The Latest Cardiac and Vascular News
Aalborg University-led research, published in PLOS Digital Health, found the CADScor System’s acoustic sensing platform identified heart failure with diagnostic accuracy comparable to a leading blood test, and with significantly fewer false positives OKLAHOMA CITY, Sept. 11, 2026…
IRVINE, Calif.–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today issued the following statement in response to the national coverage determination (NCD) for transcatheter aortic valve replacement (TAVR) released by the Centers for Medicare & Medicaid Services (CMS):“Edwards is pleased that this updated policy represents an important step toward improving and expanding patient access to TAVR while reinforcing the value of a multidisciplinary Heart Team. Aortic stenosis is a serious, pro
RODEN, Netherlands–(BUSINESS WIRE)–Interventional Medical Device Solutions (IMDS), a specialty catheter company developing purpose-built solutions for complex PCI, CHIP, and CTO procedures, today announced the U.S. launch of NHanceIT™, an over-the-wire, single-lumen microcatheter built on proprietary Skeleton Backbone™ technology. Engineered to improve lesion crossing in challenging coronary anatomy, NHanceIT is part of the IMDS portfolio designed to address distinct procedural challenges thr
SAN FRANCISCO–(BUSINESS WIRE)–Epsilon Health (“Epsilon”), the AI-native radiology practice reinventing how radiology is delivered, today emerged from stealth with $27.6 million in funding led by AlleyCorp, with participation from Uncork Capital, Renegade Partners, SemperVirens, and Jack Altman, who invested while serving as Managing Partner at Alt Capital. Epsilon is tackling one of the most urgent crises in American healthcare.Medical imaging is a foundational pillar of the U.S. healthcare sy
— Advancing global expansion, pediatric robotic surgery and telesurgery — — Growing SSi Mantra installations, procedures and utilization — FORT LAUDERDALE, Fla., Sept. 10, 2026 (GLOBE NEWSWIRE) — via IBN — SS Innovations International, Inc. (the “Company” or “SS Innovations”) (NASDAQ: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today provided an update on the Company’s continuing progress and milestones. Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “Our advanced, cost-effective SSi Mantra surgical robotic system (the “SSi Mantra”) is benefitting lives globally, one patient at a time, from a 45-day old baby needing kidney surgery in India to a cardiac patient in Sri Lanka. Our progress in democratizing access to state-of-the-art surgical robotic care continues to be reflected in growing SSi Mantra installations, procedures and utilization.” Recent Company Progress and Milestones: Global Expansion Colombia. On July 29, 2026, Dr. Sudhir Srivastava officially launched the robotic cardiac surgery program at La Fundación Cardiovascular de Colombia (FCV) in Bucaramanga, Colombia, performing the country’s first Totally Endoscopic Beating-Heart Bypass Surgery using the SSi Mantra surgical robotic system. Sri Lanka. On August 23, 2026, Kings Hospital Colombo installed the first SSi Mantra surgical robotic system in Sri Lanka, marking the official launch of the medical center’s robotic surgery program. Following its installation at Kings Hospital, the SSi Mantra has been utilized to perform the country’s first robotic-assisted cardiac surgery and over 25 other robotic surgeries within the first three weeks of operation. Global Installed Base. With the installation in Sri Lanka, the SSi Mantra’s global installed base now spans 12 countries, including a leading presence in the Company’s immense home market of India. US and EU Regulatory Review. Looking ahead, SS Innovations expects that the U.S. Food and Drug Administration will complete its review of the Company’s 510(k) premarket notification for the SSi Mantra by the end of the first quarter of 2027 and believes that a European Union CE marking certification can be obtained by the end of 2026. Pediatric Robotic Surgery Intricate Robot-Assisted Pediatric Surgery. On August 14, 2026, the Company’s SSi Mantra surgical robotic system and 5-millimeter instrumentation were utilized by Dr. M. Ramalingam to perform a robotic pyeloplasty on a 45-day-old baby at Hindusthan Hospital in Coimbatore, India. The infant recovered rapidly after successful completion of the complex yet minimally invasive kidney procedure. This accomplishment represents another proof point for the SSi Mantra’s capabilities in pediatric robotic surgery, which involves the smallest patients and requires superior precision and control during suturing and cutting, among other surgical tasks. Cumulative Pediatric Surgeries. As of August 31, 2026, a total of 258 pediatric robotic surgeries have been completed with the SSi Mantra. Robotic Telesurgery Longest-Distance Telesurgery. On July 29, 2026, a team of surgeons led by Dr. Sudhir Srivastava utilized the SSi Mantra to perform a successful robotic telesurgery between Colombia and India, spanning more than 13,600 miles (22,000 kilometers) of fiber network distance and eclipsing the previous longest-distance telesurgery record also held by the Company. The telesurgery, a robotic sleeve gastrectomy, was performed remotely from Hospital Internacional de Colombia in Bucaramanga, Colombia on a patient located at Mohak Bariatrics and Robotics in Indore, India. Expanding Ecosytem in India. On August 9, 2026, Ahmedabad, India-based Shalby Hospital joined an expanding ecosystem of healthcare institutions utilizing the SSi Mantra to perform robotic-assisted telesurgery. Three surgical procedures were successfully performed remotely from SS Innovations’ headquarters in Gurugram, India, more than 590 miles (950 kilometers) from the patients at Shalby Hospital. Launch of Telesurgery in the Philippines. On September 5, 2026, the SSi Mantra was used to perform the first telesurgery within the Philippines between Pampanga and Cotabato, a distance of approximately 1,070 miles (1,710 kilometers). Cumulative Telesurgeries. As of August 31, 2026, a total of 188 robotic telesurgeries have been completed with the SSi Mantra. Increasing Utilization and Scale 50 Robot-Assisted Surgeries in a Single Day. On August 15, 2026, the surgical team at Mohak Bariatrics and Robotics in Indore, India utilized five separate SSi Mantra systems to successfully complete 50 robotic general surgery procedures in a single day, demonstrating the robustness of the Company’s technology. Practice and Hospital Milestones. Numerous practices and hospitals across India and abroad are surpassing the 200+, 100+ and 50+ procedure milestones with the SSi Mantra, indicating growing utilization and ability to scale. Growing Installations and Procedures More than 14,000 Successful Procedures. As of September 8, 2026, the SSi Mantra cumulative installed base totaled 238, up 42% from 168 at the end of 2025 and the number of multi-specialty procedures completed with the SSi Mantra totaled 14,103, up 79% from 7,885 at the end of 2025. Broad Pool of Surgeon Users. To date, approximately 1,500 physicians have been trained on the SSi Mantra, which has been utilized to perform over 170 different types of surgical procedures. About SS Innovations SS Innovations International, Inc. (Nasdaq: SSII) develops innovative surgical robotic technologies with a vision to make the benefits of robotic surgery affordable and accessible to a larger segment of the global population. The Company’s product range includes its proprietary “SSi Mantra” surgical robotic system and its comprehensive suite of “SSi Mudra” surgical instruments, which support a variety of surgical robotic procedures including cardiac surgery. Headquartered in India, SS Innovations is a U.S. company focused on expanding the global presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions. Visit the Company’s website at ssinnovations.com or LinkedIn for more information and updates. About the SSi MantraThe SSi Mantra surgical robotic system is a user-friendly, modular, multi-arm system with advanced technology features, including: 3 to 5 modular robotic arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, a touch panel monitor for all patient related information display, a virtual real-time image of the robotic patient side arm carts, and the ability for superimposition of 3D models of diagnostic imaging. The optional SSi MantrAsana tele-surgeon console is a portable, compact alternative to the SSi Mantra’s standard surgeon command center that provides equivalent control functionality while enabling enhanced portability, ergonomic flexibility, and telesurgery capability. The SSi Mantra utilizes over 40 different types of robotic endo-surgical instruments to support different specialties, including cardiac surgery, and 5mm instruments for the pediatric population and ENT surgeries. A vision cart provides the table-side team with the same magnified 3D 4K view as the surgeon to provide better safety and efficiency. The SSi Mantra has been clinically validated in India in more than 170 different types of surgical procedures. Forward Looking StatementsThis 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’ 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. Investor Contact:The Equity Group Kalle Ahl, CFA T: (303) 953-9878 kalle.ahl@theequitygroup.com Devin Sullivan, Managing Director T: (212) 836-9608devin.sullivan@theequitygroup.com Media Contact:RooneyPartners LLCKate BarretteT: (212) 223-0561kbarrette@rooneypartners.com Corporate Communications: IBNAustin, TexasIBN.Ai512.354.7000 OfficeEditor@IBN.Ai
New research builds on earlier findings showing HFSA’s OMT-HF program improves clinician confidence in delivering guideline directed medical therapy WASHINGTON, Sept. 10, 2026 /PRNewswire/ — New research published in the Journal of Cardiac Failure provides additional evidence that…
HOUSTON–(BUSINESS WIRE)–XCath Robotics, a medical device company advancing endovascular surgical robotics, announced today the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its Iris Surgical Robotic System for remote robotic-assisted mechanical thrombectomy in patients with acute ischemic stroke. The FDA’s Breakthrough Devices Program is designed to support the development of medical devices that have the potential to provide more effective treatment f
KIRKLAND, Wash., Sept. 10, 2026 (GLOBE NEWSWIRE) — Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a leading wearable medical device and digital healthcare company, announced today that Daniel Finney has been named Vice President of Research & Development and appointed to the company’s executive leadership team. “Research and development is central to advancing our mission and expanding the role of wearable protection for at-risk patients during critical periods of recovery,” said Brian Webster, President and Chief Executive Officer. “The Cardiac Recovery System® platform was designed from the outset to evolve. Dan’s hands-on role in developing the ASSURE® WCD, together with his technical depth, product experience, and demonstrated leadership, positions him to guide our next phase of innovation and extend the platform’s value for patients and providers.” Mr. Finney succeeds Phillip D. Foshee, Jr., who led Kestra’s research and development organization from 2016 until his recent retirement. During his nearly decade-long tenure, Mr. Foshee spearheaded the development of the ASSURE WCD and helped establish the technical foundation on which Kestra continues to build. The appointment comes as Kestra advances an integrated product strategy across the Cardiac Recovery System platform. Building on its extensible architecture, Mr. Finney will lead initiatives spanning internal research and development, strategic partnerships, and the application of AI, with priorities informed by clinical evidence and real-world insights from patients and clinicians. This evidence base includes findings from the ASSURE Clinical Evaluation Post-Approval Study (ACE-PAS), the largest prospective real-world study of wearable cardioverter defibrillators conducted to date. “It has been incredibly rewarding to be part of the team that brought the ASSURE WCD from concept to market and to see firsthand its impact on patients and its role in expanding the wearable defibrillator category,” said Mr. Finney. “That experience gives me confidence in the strength and potential of the Cardiac Recovery System platform. I’m genuinely excited about our vision and roadmap, and I look forward to leading this team as we advance the next generation of wearable cardiac protection.” Mr. Finney has more than 20 years of experience in Class III medical device development, engineering management, and project management. Most recently, he served as Kestra’s Senior Director of New Product Development, leading engineering teams and product development initiatives. Before joining Kestra, he held product development roles with Stryker, Physio-Control, and Medtronic. About KestraKestra Medical Technologies, Ltd. is a commercial-stage wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. For more information, please visit www.kestramedical.com. Forward-Looking StatementsExcept where otherwise noted, the information contained in this press release is as of April 22, 2026. Statements in this press release that express a belief, expectation or intention, as well as those that are not historical fact, are forward-looking statements. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions, and we cannot ensure that any outcome expressed in these forward-looking statements will be realized in whole or in part. You can identify these statements by the fact that they use future dates or use words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek,” “potential,” “hope” and other words and terms of similar meaning. Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following: risks related to our limited operating history and history of net losses; our ability to successfully achieve substantial market adoption of our products; competitive pressures; our ability to adapt our manufacturing and production capacities to evolving patterns of demand, governmental actions and customer trends; product defects or complaints and related liability; our ability to obtain and maintain adequate coverage and reimbursement levels for our products; our ability to comply with changing laws and regulatory requirements and resulting costs; our dependence on a limited number of suppliers; and other risks and uncertainties, including those described under the heading “Risk Factors” in Kestra’s Annual Report on Form 10-K for the fiscal year ended April 30, 2026 filed with the U.S. Securities and Exchange Commission (“SEC”) on July 14, 2026, and in other periodic reports filed by Kestra with the SEC. These filings are available on the Investor Relations section of our website at https://investors.kestramedical.com/ and on the SEC’s website at https://sec.gov/. CONTACT: Media contact
Rhiannon Pickus
rhiannon.pickus@kestramedical.com
Investor contact
Neil Bhalodkar
neil.bhalodkar@kestramedical.com
CHICAGO–(BUSINESS WIRE)–Tempus AI, Inc. (NASDAQ: TEM) today announced that it has been selected by the Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services, to receive an award of up to $9.5 million to build the first autonomous clinical AI agent capable of providing safe and effective care to patients suffering from heart failure. Funding provided through ARPA-H’s ADVOCATE (Agentic AI-EnableD CardioVascular CAre TransfOrmati
The round is led by growth fund IRIS alongside Five Arrows. Funding will fuel Implicity’s next phase of growth in the US through local commercial hires, build on its established leadership across Europe, and accelerate further AI investment. Implicity already serves over 250 medical centers and monitors 120,000+ patients daily […]
