Financial

Eko Health Raises $41 Million to Scale AI-Driven Heart and Lung Disease Detection

Financial by Comments are Disabled

Supporting more than 500,000 U.S. healthcare professionals, Eko combines FDA-cleared algorithms with digital medical devices to enhance the early detection of cardiac and pulmonary diseases during physical exams.SAN FRANCISCO, June 5, 2024 /PRNewswire/ — Eko Health, a pioneer in applying artificial intelligence for early detection of heart and lung diseases, today announced it has raised $41 million in Series D financing. With participation by ARTIS Ventures, Highland Capital Partners, NTTVC, and Questa Capital, the funding round will be used to expand U.S. and global access to the company’s early disease detection platform.

Continue Reading

Supporting more than 500,000 U.S. healthcare professionals, Eko combines FDA-cleared algorithms with digital medical devices to enhance the early detection of cardiac and pulmonary diseases during physical exams.

The funding builds on recent commercial and clinical milestones, including U.S. FDA clearances for its structural heart murmur and low ejection fraction (Low EF) detection algorithms. Eko’s murmur detection algorithm was clinically validated in a Massachusetts General Hospital study and found to double identification rates of structural heart murmurs versus conventional practice in primary care. The low EF detection algorithm, developed with Mayo Clinic, was shown in an Imperial College London study to significantly enhance the identification of heart failure with reduced ejection fraction in GP clinics. By enhancing detection capabilities, Eko’s platform significantly reduces diagnostic bottlenecks, leading to earlier interventions and improved patient outcomes.

“Eko harnesses AI to unlock universal access to expert-level cardiac and pulmonary disease detection for patients everywhere,” said Connor Landgraf, CEO and co-founder of Eko Health. “Just as Ring transformed doorbells into home security systems, Eko has reinvented the world’s most ubiquitous medical tool into a powerful early disease detection platform, creating the world’s largest install base of professional AI-enabled cardiology devices.”
Cardiovascular and pulmonary diseases are among the leading causes of death worldwide, underscoring the critical need for early detection. Millions of patients remain unaware of their risk factors, often due to limited access to effective detection tools. Eko is addressing this gap by introducing sophisticated detection capabilities into any physical exam — from primary care exams at NCH Healthcare System in the U.S. to maternal-fetal health exams in Nigeria.”Eko has spent the past decade building an unparalleled dataset of digital heart and lung sounds, which it leverages to develop clinical AI for the physical world,” said Vas Bailey, PhD, Chair of the Board at Eko Health and Partner at ARTIS Ventures. “Like countless others, I lost a parent much too early to undetected heart disease. I am deeply inspired by the team’s dedication to saving lives by equipping hundreds of thousands—and soon millions—of clinicians worldwide with our groundbreaking early detection platform.”Eko will use the new capital to deepen its presence in the U.S. and accelerate its expansion into key international markets, supported by new strategic investments from Double Point Ventures in the U.S., Singapore-based global investor EDBI (the corporate investment arm of the Singapore Economic Development Board), and LG Technology Ventures, backed by the LG Group of South Korea. With the new funding and regulatory clearances, Eko is poised to rapidly expand access to its AI-enabled cardiac and pulmonary disease detection platform, empowering millions of healthcare professionals to improve patient outcomes in the coming years.About Eko HealthEko Health is a leading digital health company advancing how healthcare professionals detect and monitor heart and lung disease with its portfolio of digital stethoscopes, patient and provider software, and AI-powered analysis. Its FDA-cleared platform, used by over 500,000 healthcare professionals worldwide, allows them to detect earlier and with higher accuracy, diagnose with more confidence, manage treatment effectively, and ultimately give their patients the best care possible. Eko Health is headquartered in Emeryville, California, with over $165 million in funding from ARTIS Ventures, DigiTx Partners, Double Point Ventures, EDBI, Highland Capital Partners, LG Technology Ventures, Mayo Clinic, Morningside Technology Ventures Limited, NTTVC, Questa Capital, and others.Media Contact:Sam Moore[email protected]SOURCE Eko Health

Continue Reading →

HeartSciences Regains Compliance with Nasdaq Listing Requirements

Financial by Comments are Disabled

Southlake, TX, June 04, 2024 (GLOBE NEWSWIRE) — Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced that on June 3, 2024, the Company received formal notice from the Listing Qualifications Staff of the Nasdaq Stock Market LLC indicating that HeartSciences has regained compliance with bid price requirement as set forth in Listing Rule 5550(a)(2), and that the Company is therefore in compliance with the Nasdaq Capital Market’s listing requirements and the scheduled hearing has now been cancelled. About HeartSciences Heart Test Laboratories, Inc. d/b/a HeartSciences is a medical technology company focused on applying innovative AI-based technology to an ECG (also known as an EKG) to expand and improve an ECG’s clinical utility. Millions of ECGs are performed every week and the Company’s objective is to improve healthcare by making it a far more valuable cardiac screening tool, particularly in frontline or point-of-care clinical settings. HeartSciences has one of the largest libraries of AI-ECG algorithms and is developing AI-ECG solutions to be made available on either a hardware agnostic cloud-based platform or  its proprietary MyoVista® wavECG™ device,  to help identify cardiovascular disease in any care setting worldwide in a manner to best suit different care providers. HeartSciences’ first product candidate for FDA clearance, the MyoVista® wavECG™, or the MyoVista®, is a resting 12-lead ECG that is also designed to provide diagnostic information related to cardiac dysfunction which has traditionally only been available through the use of cardiac imaging. The MyoVista® also provides conventional ECG information in the same test. For more information, please visit: https://heartsciences.com/. X: @HeartSciences Safe Harbor Statement This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are made under the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and are relating to the Company’s future financial and operating performance. All statements, other than statements of historical facts, included herein are “forward-looking statements” including, among other things, statements about HeartSciences’ beliefs and expectations. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. The expectations reflected in these forward-looking statements involve significant assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Potential risks and uncertainties include, but are not limited to, risks discussed in HeartSciences’ Annual Report on Form 10-K for the fiscal year ended April 30, 2023, filed with the U.S. Securities and Exchange Commission (the “SEC”) on July 18, 2023, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended January 31, 2024, filed with the SEC on March 14, 2024 and in HeartSciences’ other filings with the SEC at www.sec.gov. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements. Contacts: HeartSciencesGene Gephart+1-682-244-2578 (US)info@heartsciences.com InvestorsGilmartin GroupVivian Cervantesinvestorrelations@heartsciences.com

Continue Reading →

OBVIUS Robotics™ Announces Growth Into New Development and Operations Facility

Financial by Comments are Disabled

SUNRISE, Fla., June 4, 2024 /PRNewswire/ — Obvius Robotics, a medical device company developing an innovative technology platform for democratizing vascular access, today announced its move into a new development and operations facility. The South Florida facility will enable Obvius Robotics to support its growth as the company prepares for clearance and commercialization.
Obvius Robotics has developed technology that can be used with minimal training or experience, initially targeting central venous catheterization (CVC) procedures. The CERTA Access System is a hand-held, image guided device that enables clinicians to single-handedly target anatomical structures and access them with the push of a button using a proprietary targeting system and needle assembly. Early clinical use of the CERTA has demonstrated a 100% access success rate (link).
As the most common interventional procedure performed in the United States, CVC is a key platform from which to launch critical medical interventions for acutely ill patients and patients requiring surgery. The procedure involves gaining access to one of the great veins (internal jugular, subclavian, or femoral) to place a multi-lumen catheter for rapid replacement of blood volume, administration of emergency medicines and analgesics, and hemodynamic monitoring. Despite the broad use of CVC, these procedures carry a complication rate between 4% and 11% due to a lack of training and experience.
“The goal of Obvius Robotics is to democratize access, improve outcomes, and become the new standard of care in CVC,” said Russell Seiber, president and CEO of Obvius Robotics. “The new facility will not only support development and production of the CERTA Access System for CVC, but will also be a center of innovation to expand the CERTA platform into new applications”.
The CERTA Access System is not approved for clinical use at this time, but the company is currently preparing its submission to the U.S. Food and Drug Administration (FDA) for market clearance.
About Obvius Robotics
Obvius Robotics is a privately held medical device company based in South Florida with clinical offices in the Center for Device Innovation at the Texas Medical Center, Houston, that is developing technology for image-guided access of structures within the body. The platform technology, the CERTA Access System, incorporates robotics and imaging to improve the accuracy, safety, and consistency of accessing targeted anatomy.  The company’s first clinical application is central venous catheter placement, a high-volume procedure in which CERTA has the potential to aid clinicians of varying levels of training and experience in safely and effectively achieving vascular access. Note: The CERTA Access System is not approved or cleared for use in patients in any geography at this time.
SOURCE OBVIUS Robotics, Inc.

Continue Reading →

Amarin Board of Directors Announces CEO Transition

Financial by Comments are Disabled

— Board Appoints Aaron Berg as President & CEO — — Patrick Holt to Step Down as President & CEO to Pursue Other Opportunities — DUBLIN and BRIDGEWATER, N.J., June 04, 2024 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced that the Company’s Board of Directors has appointed Aaron Berg, currently Amarin’s Executive Vice President and President of the U.S. Business, as President and Chief Executive Officer (CEO). The appointment of Mr. Berg follows the resignation of Patrick Holt as President & CEO of the Company. “On behalf of the Company’s Board of Directors, I thank Pat for his contributions to Amarin, and I welcome working closely again with Aaron as President & CEO,” said Odysseas Kostas, MD, the Chairman of the Board. “No one knows the company better than Aaron, and we look forward to him contributing meaningfully as CEO.” “As I begin this new role, my focus is clear – to find ways to deliver value for investors, and to maximize the potential of VASCEPA®/VAZKEPA for patients,” said Aaron Berg, President & CEO, Amarin. “I look forward to continuing to work with our Board of Directors and our tremendous team focusing on these priorities for the Company as we move forward.” Mr. Berg joined Amarin in November 2012 and has more than 30 years of biopharmaceutical industry experience. Mr. Berg initially served as Amarin’s Vice President, Marketing and Managed Care. He was promoted to Senior Vice President, Marketing and Sales in February 2014, and to the position of Senior Vice President and Chief Commercial Officer in April 2018. Before joining Amarin, Mr. Berg served as President and Chief Executive Officer for Essentialis, Inc., a development stage pharmaceutical company where he led the company’s work on triglyceride management. Prior to joining Essentialis, Mr. Berg served as Vice President of Marketing and Sales at Kos Pharmaceuticals (Kos), where he was instrumental in driving annual revenues approaching $1 billion. Mr. Berg worked at Kos until it was acquired by Abbott Laboratories in December 2006 for $3.7 billion. About Amarin Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world.   Forward-Looking Statements   This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about the potential for VASCEPA (marketed as VAZKEPA in Europe); beliefs about icosapent ethyl (IPE)’s role concerning appropriate patients suffering from cardiovascular disease (CVD) and  potential population health impact, as well as general beliefs about the safety and effectiveness of VASCEPA. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including Amarin’s annual report on Form 10-K for the full year ended 2023. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate. Availability of Other Information About Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (amarincorp.com/investor-relations), including but not limited to investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.    Availability of Other Information About Amarin Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.  Amarin Contact Information    Investor & Media Inquiries:    Mark Marmur  Amarin Corporation plc    PR@amarincorp.com 

Continue Reading →

Microbot Medical Announces $2.35 Million Registered Direct Offering Priced At-The-Market under Nasdaq Rules

Financial by Comments are Disabled

HINGHAM, Mass., June 03, 2024 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT) today announced that it has entered into definitive agreements for the purchase and sale of 1,566,669 shares of the Company’s common stock at a purchase price of $1.50 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, the Company will issue unregistered series F preferred investment options. The series F preferred investment options to purchase up to 3,133,338 shares of common stock have an exercise price of $1.50 per share and are immediately exercisable following issuance for a period of two years thereafter. The closing of the registered direct offering and the concurrent private placement is expected to occur on or about June 4, 2024, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offerings. The gross proceeds to the Company from the offerings are expected to be approximately $2.35 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the offerings for the continued development, commercialization and regulatory activities for the Company’s LIBERTY® Robotic System, expansion and development of additional applications derived from the Company’s existing IP portfolio, and for working capital and other general corporate purposes. The shares of common stock described above (but not the series F preferred investment options issued in the concurrent private placement or the shares of common stock underlying such series F preferred investment options) are being offered by the Company pursuant to a “shelf” registration statement on Form S-3 (File No. 333-275634) previously filed with the Securities and Exchange Commission (the “SEC”) and declared effective by the SEC on December 4, 2023. The offering of the shares of common stock is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 865-5711 or e-mail at placements@hcwco.com. The series F preferred investment options described above are being issued in a concurrent private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the series F preferred investment options, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the series F preferred investment options and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About Microbot Medical Microbot Medical Inc. (NASDAQ: MBOT) is a pre-clinical medical device company that specializes in transformational micro-robotic technologies, with the goals of improving clinical outcomes for patients and increasing accessibility through the natural and artificial lumens within the human body. The investigational LIBERTY® Endovascular Robotic Surgical System aims to improve the way surgical robotics are being used in endovascular procedures today, by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The Company believes the LIBERTY® Endovascular Robotic Surgical System’s remote operation has the potential to be the first system to democratize endovascular interventional procedures. Further information about Microbot Medical is available at http://www.microbotmedical.com. Safe Harbor Statements to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects” and “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, the completion of the offerings, the satisfaction of customary closing conditions related to the offerings, the intended use of proceeds from the offerings, market conditions, risks inherent in the development and/or commercialization of the LIBERTY® Endovascular Robotic Surgical System, the outcome of its studies to evaluate LIBERTY® Endovascular Robotic Surgical System, uncertainty in the results of pre-clinical and clinical trials or regulatory pathways and regulatory approvals, including whether the Company’s pivotal study in humans is successful, any failure or inability to recruit physicians and clinicians to serve as primary investigators to conduct regulatory studies which could adversely affect or delay such studies, disruptions resulting from new and ongoing hostilities between Israel and the Palestinians and other neighboring countries, any lingering uncertainty resulting from the COVID-19 pandemic, need and ability to obtain future capital, and maintenance of intellectual property rights. Additional information on risks facing Microbot Medical can be found under the heading “Risk Factors” in Microbot Medical’s periodic reports filed with the Securities and Exchange Commission (SEC), which are available on the SEC’s web site at www.sec.gov. Microbot Medical disclaims any intent or obligation to update these forward-looking statements, except as required by law. Investor Contact: Michal Efraty +972-(0)52-3044404 IR@microbotmedical.com

Continue Reading →

HeartFlow AI Plaque Analysis Achieves Major Milestone Towards Medicare Coverage

Coronary/Structural Heart Financial by Comments are Disabled

MOUNTAIN VIEW, Calif., June 03, 2024 (GLOBE NEWSWIRE) — HeartFlow, a leader in cardiovascular healthcare technology, is pleased to announce a key Medicare policy development, which should allow for future expanded patient access to their Plaque Analysis product. Five Medicare Administrative Contractors (MACs), CGS, NGS, Noridian, Palmetto GBA, and WPS, released draft Local Coverage Determinations (LCD) for Artificial Intelligence Enabled CT Based Quantitative Coronary Topography (AI-QCT)/Coronary Plaque Analysis (AI-CPA). These draft LCDs recognize the importance of quantifying coronary artery plaque, which underscores the pivotal role HeartFlow technology plays in diagnosing and managing treatment for patients in need of cardiovascular care. HeartFlow’s accurate and actionable Plaque Analysis aligns with the Centers for Medicare & Medicaid Services (CMS) commitment to supporting technologies that enhance diagnostic accuracy and patient care: HeartFlow Plaque Analysis is the only FDA cleared plaque analysis with a reported 95% agreement prospectively compared to the gold standard, IVUS.¹Two out of three patients had their medical management changed and more precisely tailored with HeartFlow Plaque Analysis.² Plaque Analysis is a major function of the HeartFlow portfolio, which offers the only comprehensive, AI-driven, precision coronary care solution based on the guideline-directed cardiac CT pathway, backed by robust clinical evidence and guidelines. HeartFlow FFRCT has an established reimbursement pathway which is covered for 99% of people in the US with health insurance. Leveraging our expertise and proven success creating new AI reimbursement categories as done with HeartFlow FFRCT, similar coverage and adoption for Plaque Analysis is anticipated, ensuring it becomes an integral part of coronary care. “We are excited about this milestone, as it highlights the critical importance of accurately quantifying plaque in cardiovascular disease management,” said John Farquhar, chief executive officer at HeartFlow. “This recognition by the MACs in the draft policies is a testament to the clinical value of Plaque Analysis and its potential to revolutionize how cardiovascular disease is diagnosed and treated, for all.” The release of these draft LCDs mark the first step in integrating accurate plaque measurement into standard clinical practice. Next steps toward coverage include a period for input from clinicians and other stakeholders before policy is finalized and released. “We are confident that Plaque Analysis will not only meet but exceed the rigorous standards of Medicare,” added Cara Santillo, Senior Vice President of Market Access and Reimbursement at HeartFlow. “This nod of support from the MACs underscores the importance of access and equity in cardiovascular care by ensuring that all patients, regardless of background, receive the critical insights needed for treatment for cardiovascular disease.” About HeartFlow, Inc.HeartFlow is transforming precision coronary care with the only AI-powered non-invasive integrated heart care solution across the CCTA pathway. As the pioneer of FFRCT, which is now supported by the ACC/AHA Chest Pain Guideline, HeartFlow continues to advance the diagnosis and management of CAD. HeartFlow’s suite of non-invasive technologies includes its FFRCT Analysis, RoadMap™Analysis, and Plaque Analysis. To date, more than 500 peer-reviewed publications have validated our approach and, more importantly, our technologies have helped clinicians diagnose and manage over 250,000 patients. For more information, visit www.heartflow.com. Media Contact Linly Ku Digital Marketing Manager media@heartflow.com Investor Contact Nick Laudico VP of Business Development and Investor Relations nlaudico@heartflow.com 1 Narula et al. Prospective Deep Learning-based Quantitative Assessment of Coronary Plaque by CT Angiography Compared with Intravascular Ultrasound EHJ 2024. ² Rinehart et al. JSCAI 2024. https://doi.org/10.1016/j.jscai.2024.101296

Continue Reading →

UltraSight collaborates with Mayo Clinic to advance next generation cardiac care with AI

Financial by Comments are Disabled

New collaboration formed to enhance detection and diagnosis of cardiovascular disease
TEL AVIV, Israel , June 3, 2024 /PRNewswire/ — UltraSight, a pioneer in digital health transforming cardiac imaging with artificial intelligence, is collaborating with Mayo Clinic on a new endeavor with the goal of enhancing cardiac care by harnessing the power of AI in point-of-care ultrasound.UltraSight and Mayo Clinic will jointly develop algorithms for analyzing and interpreting cardiac ultrasound images. This collaboration aims to create a new end-to-end solution and decision support to help healthcare providers make more informed diagnoses and treatment decisions using point-of-care ultrasound (PoCUS) devices. By gaining access to Mayo Clinic’s team of researchers, clinicians and data, UltraSight will be best positioned to enhance and scale its introduction of new cardiac solutions to the market.
With cardiovascular disease affecting approximately 130 million people globally, according to the American Heart Association, the demand for timely cardiac diagnosis and access to consistent cardiac care is on the rise.
“According to the American Heart Association, the prevalence of cardiovascular disease is more than 75 percent in individuals over 60,” said Paul Friedman, M.D., Chair of the Department of Cardiovascular Medicine at Mayo Clinic in Rochester, Minnesota. “Early detection may prevent the progression of heart disease or stroke.  The addition of AI to point-of-care ultrasound, widely available and inexpensive, stands to eliminate significant barriers to adoption by guiding users in image acquisition and supporting image interpretation – making the approach highly scalable for early diagnosis and periodic cardiac monitoring.”
“UltraSight Real-time Guidance software harnesses the power of AI to allow more medical practitioners to capture images with confidence,” said Davidi Vortman, CEO of UltraSight. “However, obtaining diagnostic quality cardiac images at the patient point of care is only the first step needed to increase patient access to quality care. We firmly believe that point-of-care ultrasound, when enhanced by the capabilities of AI, holds potential to optimize patient care. Through this collaboration, we plan to enhance our solution to detect and manage cardiac conditions in a more scalable and cost-effective way, ultimately helping more patients receive timely treatment.”
“We know that over the next decade, training programs around the world will not graduate enough specialists and technologists to meet the demands of an aging population,” said John Halamka, M.D., President of Mayo Clinic Platform. The best option in our toolkit is to embrace AI in a way that democratizes access to knowledge. Mayo Clinic and UltraSight will work together to enable a wider spectrum of caregivers to obtain cardiac ultrasound data and understand the results, serving many more patients globally.”
Mayo Clinic is now an investor at UltraSight and has a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.
For more information about UltraSight, visit www.ultrasight.com. For more information about Mayo Clinic, visit www.mayoclinic.org
About UltraSightUltraSight’s mission is to make diagnostic imaging more accessible by empowering medical professionals to successfully acquire timely and accurate cardiac ultrasound images anywhere. UltraSight’s AI-driven software offers real-time guidance, making cardiac ultrasound accessible and efficient, which may lead to quicker diagnoses and improved patient care. The company was awarded a patent for its real-time guidance solution for ultrasound devices. UltraSight’s software has FDA 510(k) Clearance, is UKCA and CE Marked, and has Israeli AMAR Clearance to assist medical professionals in performing cardiac ultrasound scans. For more news and information, visit our website or follow UltraSight on LinkedIn and Twitter
SOURCE UltraSight

Continue Reading →

Medtronic announces closing of public offering of €3.0 billion of senior notes

Financial by Comments are Disabled

DUBLIN, June 3, 2024 /PRNewswire/ — Medtronic plc (the “Company”) (NYSE: MDT) announced today that its wholly-owned indirect subsidiary, Medtronic, Inc., has closed a registered public offering (the “Offering”) of €850,000,000 principal amount of 3.650% senior notes due 2029, €850,000,000 principal amount of 3.875% senior notes due 2036, €600,000,000 principal amount of 4.150% senior notes due 2043, and €700,000,000 principal amount of 4.150% senior notes due 2053 (collectively, the “Notes”). All of Medtronic, Inc.’s obligations under the Notes are fully and unconditionally guaranteed by the Company and Medtronic Global Holdings S.C.A., a wholly-owned subsidiary of the Company and the indirect parent of Medtronic, Inc., on a senior unsecured basis.
The net proceeds from the Offering are approximately €2.97 billion, after deducting underwriting discounts and estimated expenses related to the Offering payable by Medtronic, Inc. The net proceeds of the Offering are expected to be used for general corporate purposes, which may include repayment of outstanding commercial paper and other indebtedness.
Citigroup Global Markets Limited, J.P. Morgan Securities plc, Merrill Lynch International and Mizuho International plc were the joint book-running managers for the Offering, Barclays Bank PLC, Deutsche Bank AG, London Branch, Goldman Sachs & Co. LLC and HSBC Bank plc were the senior co-managers for the Offering, and Drexel Hamilton, LLC, Guzman & Company, Independence Point Securities LLC and Siebert Williams Shank & Co., LLC were the co-managers for the Offering.  The Offering was made by means of a prospectus dated March 3, 2023 and prospectus supplement (together, the “Prospectus”), copies of which may be obtained for free by visiting EDGAR on the U.S. Securities and Exchange Commission website at www.sec.gov. Alternatively, copies of the Prospectus may be obtained by contacting Citigroup Global Markets Limited, toll-free at +1 800 831 9146, J.P. Morgan Securities plc at +44-20 7134-2468 (non-U.S. investors), or J.P. Morgan Securities LLC collect at +1-212-834-4533 (U.S. investors), Merrill Lynch International, toll free at +1 800 294 1322 and Mizuho International plc, at +44 20 7248 3920.
About MedtronicBold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary.
Forward-Looking Statements
This press release may be deemed to contain forward-looking statements regarding future events that are subject to the safe harbor created under Private Securities Litigation Reform Act of 1995 and other safe harbors under the Securities Act and the Securities Exchange Act of 1934. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including but without limitation, statements relating to the expected use of proceeds from the Offering.
You should pay particular attention to the important risk factors and cautionary statements referenced in the “Risk Factors” section of the prospectus related to the offering referenced above, as well as the risk factors and cautionary statements described in Medtronic plc’s filings with the SEC, including the risk factors contained in Medtronic plc’s most recent Annual Report on Form 10-K. Medtronic plc does not undertake to update its forward-looking statements.

Contacts:

Erika Winkels

Ryan Weispfenning

Public Relations

Investor Relations

+1-763-526-8478

+1-763-505-4626

SOURCE Medtronic plc

Continue Reading →

SS Innovations Engages BDO as its new Auditor

Financial by Comments are Disabled

FORT LAUDERDALE, Fla., May 31, 2024 (GLOBE NEWSWIRE) — SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), a developer of innovative surgical robotic technologies dedicated to making world class robotic surgery affordable and accessible to a global population, today announced that it has engaged BDO India LLP (“BDO”) as its independent registered public accounting firm. The Company believes that the selection of BDO will facilitate SS Innovations’ strategy to uplist its common stock to a National Securities Exchange. In addition, the engagement of BDO reflects the Company’s commitment to transparent financial and accounting practices and regulatory compliance. SS Innovations has demonstrated significant operational success, reporting 32 successful installations of its flagship SSi Mantra Surgical Robotic System in medical facilities across India. This innovative robotic surgical system has been integral to the launch of four cardiac surgery programs, broadening the spectrum of robotic cardiac surgeries available in India. For the quarter ended March 31, 2024, SS Innovations sold 8 SSi Mantra Surgical Robotic Systems and reported revenues of approximately US $7 million, which exceeds revenues reported for the entire year ended December 31, 2023. “SS Innovations is committed to democratizing access to quality healthcare while ensuring transparency for our shareholders,” stated SS Innovations’ Founder, Chairman and Chief Executive Officer, Dr. Sudhir Srivastava. “The engagement of an audit firm of the caliber and reputation of BDO is a crucial component of this commitment, serving as a bridge to our uplisting strategy and reflecting our dedication to open and transparent financial and accounting practices. This initiative is part of our broader mission to bring advanced, precise surgical solutions to every corner of the globe and to make top-tier medical care accessible to all.” Barry Cohen, COO of the Americas for SS Innovations, added, “Engaging BDO as our auditor is a strategic move which we believe will facilitate our journey to uplist our common stock to a National Securities Exchange. Our operational achievements, demonstrated by over 1,200 operations performed using the SSi Mantra, showcase our readiness for sustained, long-term growth. This is not just a procedural step but an instrumental one, which will help prepare us for the next phase of expansion, and help solidify our market position.” Mr. Cohen further noted, “The SSi Mantra has been clinically validated in 70 types of surgical procedures, demonstrating mitigation of R&D risk. We are targeting a global market, beginning with India, which alone has a population of 1.4 billion people and about 70,000 hospitals. We have begun to capture market share in India with our 32 SSi Mantra installations. We look forward to continuing to showcase SSi Mantra’s affordability, reliability and unique capabilities in a diverse and demanding healthcare environment.” About SS Innovations International, Inc. SS Innovations International, Inc. (OTC: SSII) is a developer of innovative surgical robotic technologies with a vision to make the benefits of robotic surgery affordable and accessible to a larger part of the global population. SSII’s product range includes its proprietary “SSi Mantra” surgical robotic system, and “SSi Mudra”, its wide range of surgical instruments capable of supporting a variety of surgical procedures including robotic cardiac surgery. SSII’s business operations are headquartered in India and SSII has plans to expand the presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions, globally. For more information, visit SSII’s website at ssinnovations.com or LinkedIn for updates. About SSi Mantra Supporting advanced, affordable, and accessible robotic surgery, the SSi Mantra Surgical Robotic System provides the capabilities for multi-specialty usage including cardiothoracic, head and neck, gynecology, urology, general surgery and more. With its modular arm configuration, 3D 4K vision open-console design and superior ergonomics, the system engages with the surgeon and surgical teams to improve safety and efficiency during procedures. The SSi Mantra has received Indian Medical Device regulatory approval (CDSCO) and is clinically validated in India in more than 60 different types of surgical procedures. The Company has initiated the regulatory approval process in the United States and the EU, with approvals anticipated in 2025. Forward-Looking Statements This press release may contain statements that are not historical facts and are considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. The words “anticipate,” “assume,” “believe,” “estimate,” “expect,” “will,” “intend,” “may,” “plan,” “project,” “should,” “could,” “seek,” “designed,” “potential,” “forecast,” “target,” “objective,” “goal,” or the negatives of such terms or other similar expressions to identify such forward-looking statements. These statements relate to future events or SS Innovations International’s future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. For more information: PCG AdvisoryJeff Ramsonjramson@pcgadvisory.com

Continue Reading →
1 … 79 80 81 82 83 … 485