Author: Ken Dropiewski

EHRA 2026 Studies Reveal Why False Positives Persist in AI-Equipped Implantable Cardiac Monitors

Research identifies guideline-based interpretation gaps and signal-detection issues behind non-actionable alerts and shows how an additional cloud-based AI layer can significantly reduce clinician review burden while maintaining high sensitivity April 14, 2026 08:00 ET  | Source: Implicity CAMBRIDGE, Mass., April 14, 2026 (GLOBE NEWSWIRE) — Implicity, a leader in remote patient monitoring […]

SCAI Reappoints JSCAI Founding Editor-in-Chief Alexandra J. Lansky, MD, MSCAI, for Second Term

WASHINGTON—The Society for Cardiovascular Angiography & Interventions (SCAI) today announced that Alexandra J. Lansky, MD, MSCAI, has been reappointed to a second five-year term as Editor-in-Chief of JSCAI, the official peer-reviewed journal of SCAI. SCAI launched JSCAI in 2022 as a fully digital platform to advance interventional cardiology research and practice, appointing Dr. […]

New STORM-PE Data Show Computer Assisted Vacuum Thrombectomy with Anticoagulation Resulted in Significantly Better Functional Outcomes at 90 Days Compared to Anticoagulation Alone for Pulmonary Embolism Patients

ALAMEDA, Calif., April 13, 2026 /PRNewswire/ — Penumbra, Inc. (NYSE: PEN) announced 90-day results of the landmark STORM-PE randomized controlled trial (RCT), which found that patients with acute intermediate-high risk pulmonary embolism (PE) who were treated with computer assisted vacuum thrombectomy (CAVT™) plus anticoagulation achieved greater functional improvement, including walking significantly further and […]

Radical™ Catheter Technologies Announces U.S. FDA 510(k) Clearance for its 6F Neurovascular Catheter — Broadening Access Across a Wide Range of Applications

Radical Catheter Technologies Continues to Expand its Best-in-Class Patented Platform and Scale its Specialized Neurovascular Commercialization Team Radical Catheter Technologies Continues to Expand its Best-in-Class Patented Platform and Scale its Specialized Neurovascular Commercialization Team

Transeptal Mitral Annuloplasty With the AMEND System: 6-Month Results of First in Man Cohort in Circulation: Cardiovascular Interventions

Transeptal Mitral Annuloplasty With the AMEND System: 6-Month Results of First in Man Cohort, by Drs. Melica, Carasso, Butnaru, Gogorishvili, Metreveli, Modine, Kurashvili, Farkash, Meerkin, has been accepted for publication in Circulation: Cardiovascular Interventions. Background: The AMEND implant is a semi-rigid closed D-shaped annuloplasty ring deployed through a transvenous transeptal […]

Sirtex Medical’s DOORwaY90 Study Demonstrates 100% Local Tumor Control with SIR-Spheres®, Setting a New Benchmark in Y-90 for HCC

The DOORwaY90 study met its prespecified co-primary endpoints, achieving a best overall response rate (ORR) of 99% WOBURN, Mass., April 13, 2026 /PRNewswire/ — Sirtex Medical (“Sirtex”), a leading manufacturer of interventional oncology and embolization solutions, today announced…

Heartflow Files Patent Infringement Lawsuit Against Cleerly

Heartflow asserts that Cleerly infringed foundational patented technology central to the Heartflow PlatformMOUNTAIN VIEW, Calif., April 13, 2026 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), today announced that it has filed a patent infringement lawsuit against Cleerly, Inc. in the United States District Court for the Eastern District of Texas. The complaint seeks permanent injunctive relief and damages arising from Cleerly’s unauthorized and continued use of Heartflow’s patented technology. Heartflow asserts that Cleerly’s Ischemia, Plaque Analysis, and Compare products infringe six of Heartflow’s patents with priority dates from 2012 to 2018, protecting Heartflow innovations developed years before the introduction of any Cleerly product. The filed complaint can be accessed on Heartflow’s website here. “Heartflow pioneered a significant medical technology that has touched over 600,000 patients’ lives. Our team has worked tirelessly since 2010 to develop the Heartflow Platform, a first-of-its-kind AI solution that has been used to detect and manage coronary artery disease,” said John Farquhar, CEO of Heartflow. “We take seriously our responsibility to protect the intellectual property that supports this field and the clinicians and patients it serves.” Heartflow maintains a robust intellectual property portfolio comprising over 600 granted patent assets worldwide. The Company remains focused on advancing its platform and expanding access to precise, non-invasive cardiovascular care. About Heartflow’s Technology and ResearchHeartflow’s technology is redefining precision cardiovascular care through clinically-proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,800 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by ACC/AHA guidelines and supported by more than 600 peer-reviewed publications, Heartflow has redefined how clinicians manage care for over 600,000 patients worldwide.1 Key benefits include: Proprietary data pipeline: Built from more than 160 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible insights across diverse patient populations.Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been validated through clinical evidence in over 200 studies assessing over 365,000 patients. Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 97%.Seamless clinical integration via upgraded workflow: Heartflow delivers final quality-reviewed analyses instantly upon order, enabling clinicians to move from diagnosis to decision without delay.Quality system, global security and patient-data integrity compliance: Heartflow meets or exceeds leading international standards, including HITRUST, SOC 2 Type 2, ISO 13485, and ISO 27001. About Heartflow, Inc.Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow — all without invasive procedures. Discover how we’re shaping the future of cardiovascular care at heartflow.com. Media ContactElliot Levyelevy@heartflow.com Investor ContactNick Laudiconlaudico@heartflow.com _______________________ 1 Gulati, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation & Diagnosis of Chest Pain. J Am Coll Cardiol.

Microbot Medical® Commences Full Market Release (FMR) of the LIBERTY® Endovascular Robotic System in the U.S. at the Society of Interventional Radiology (SIR) Annual Scientific Meeting

Successful Execution of the Limited Market Release (LMR) Includes Adoption by Globally Recognized Healthcare Systems in the U.S. Market and Demonstrates Broad Market Scalability in Key Endovascular ProceduresHINGHAM, Mass., April 13, 2026 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT), developer and distributor of the innovative LIBERTY® Endovascular Robotic System, announced today that it has successfully executed its limited market release (LMR) and will commence its full market release (FMR) in the U.S. as planned. To date, LIBERTY has been adopted by multiple healthcare systems with dozens of hospitals in their networks, including globally recognized hospitals such as Emory Healthcare and Tampa General Hospital. Microbot considers this achievement a reflection of the highly effective execution of the LIBERTY System’s LMR and positions the Company to commence the FMR of the LIBERTY System as originally planned, at the Society of Interventional Radiology (SIR) Annual Scientific Meeting, being held in Toronto, ON, Canada, from April 11-15. The LIBERTY system is creating an entirely new category as the only FDA-cleared, single-use, remotely operated robotic system. It has been successfully used commercially across a variety of procedures, including Prostate Artery Embolization (PAE), Uterine Fibroid Embolization (UFE), Genicular Artery Embolization (GAE), Y90 mapping, Y90 deliveries, and peripheral arterial interventions. Physicians have highlighted LIBERTY’s precision, short learning curve, fast setup, the ability to use their preferred wires and catheters, as well as the potential to improve efficiency by reducing procedure time and number of instruments used to perform such procedures. In preparation for the FMR, the Company has further enhanced its commercial team core capabilities by adding salespeople in key locations and broadening its sales footprint from four to eight sales territories, with a goal of having 12 territories across the U.S. by the end of 2026. “We successfully achieved our goals for the limited market release of the LIBERTY System, including its adoption by leading hospitals across multiple peripheral procedures, giving us the momentum to commence, as planned, the full market release at the SIR conference,” commented Harel Gadot, Chairman, President & CEO. “It’s exciting to see the level of enthusiasm among our existing customers, first when they initially use LIBERTY, utilizing it across multiple procedures, and then as they expand it to other hospital sites within their network. The variety of case types shows the system’s flexibility, and its ease of use is generating high customer satisfaction. I also believe the level of customer adoption during the limited market release in such a short time further demonstrates a shorter sales cycle compared to traditional surgical robots, which is another key differentiator and one we believe will lead to accelerated adoption.” SIR represents over 8,000 practicing interventional radiology physicians, trainees, medical students, scientists, and clinical associates. This will be the first opportunity for the Company to showcase the LIBERTY system at the conference, which features its primary addressable U.S. target market. SIR, along with the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) have recently adopted new guidelines, which were published in CardioVascular and Interventional Radiology (CVIR), and endorsed by at least eight other medical societies. These guidelines cover updated evidence, address new exposure sources such as CT-guided procedures and radioembolization, and radiation protection during pregnancy for female practitioners, as well as addresses musculoskeletal risks for interventional radiology staff. This follows a recent American Medical Association (AMA) policy adopted late last year to strengthen protections for health care professionals from occupational exposure to ionizing radiation. “This year’s SIR conference is a pivotal moment for Microbot Medical, and the timing of the conference represents an optimal opportunity for our team to leverage the market feedback to commence the full market release of the LIBERTY System,” added Mr. Gadot. “Our targeted end users will be in attendance, and we plan to engage with them directly, enhancing our opportunities over the coming months as we broaden our presence in existing territories and expand into new ones.” The Company plans to meet with physicians and other stakeholders, to showcase the LIBERTY system at booth #423, and to further educate physicians on the system’s full capabilities to accelerate market adoption in the U.S. LIBERTY is the only FDA cleared, single-use, remotely operated robotic system for peripheral endovascular procedures. It is designed for precise vascular navigation while aiming to reduce radiation exposure and physical strain, addressing key clinical and operational challenges faced by interventional radiology teams. About Microbot Medical Microbot Medical Inc. (NASDAQ: MBOT) is a commercial stage medical device company focused on transforming endovascular procedures through advanced robotic technology. Microbot’s LIBERTY® Endovascular Robotic System is the world’s first FDA cleared single-use, remotely operated robotic solution designed for precision, efficiency and safety. Backed by a strong intellectual property portfolio and a commitment to innovation, Microbot is driving the future of endovascular care. Learn more at www.microbotmedical.com and connect on LinkedIn and X. Safe Harbor Statements to future financial and/or operating results, future adoption of products, future growth in research, technology, clinical development, commercialization 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 “contemplates,” “continues,” “could,” “forecasts,” “intends,” “may,” “might,” “possible,” “potential,” “predicts,” “projects,” “should,” “would,” “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates” and similar expressions) should also be considered to be forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements involve risks and uncertainties, including, without limitation, market conditions, risks inherent in the commercialization of the LIBERTY® Endovascular Robotic System, and in the development of future versions of or applications for the system, uncertainty in the results of regulatory pathways and regulatory approvals, uncertainty resulting from political, social and geopolitical conditions, particularly any changes in personnel or processes or procedures at the FDA and announcements of tariffs on imports into the U.S., disruptions resulting from new and ongoing hostilities between Israel and the Palestinians, Iran and other neighboring countries, 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. Contacts: IR@microbotmedical.comMedia@microbotmedical.com

Stryker signs definitive agreement to acquire Amplitude Vascular Systems to add next-generation IVL technology to peripheral vascular portfolio

Portage, Michigan, April 13, 2026 (GLOBE NEWSWIRE) — Stryker (NYSE:SYK), a global leader in medical technologies, announced that it has signed a definitive agreement to acquire Amplitude Vascular Systems, Inc. (AVS), a privately held medical technology company developing a next-generation intravascular lithotripsy (IVL) platform designed to treat calcified peripheral arterial disease. The acquisition will strengthen Stryker’s Peripheral Vascular (PV) portfolio by adding revascularization technology. Once cleared for use in applicable markets, the product will complement Stryker’s existing PV offerings and support the company’s strategy to expand its presence in arterial disease treatment. “This acquisition represents an important step in advancing our vision to build a comprehensive peripheral vascular platform and address significant unmet clinical needs,” said Kevin Lobo, Chair and CEO, Stryker. “Combining this innovation with Stryker’s scale and clinical expertise, we believe we can help expand treatment options for physicians and improve care for patients with calcified peripheral arterial disease.” AVS’ technology is designed to use pulsed CO₂-generated pressure waves uniformly delivered through an IVL balloon catheter, to fracture calcium and optimize luminal gain. The platform is designed to enhance catheter deliverability, treatment speed and therapy efficiency. IVL is a fast-growing technology in cardiovascular intervention and is used to treat calcified peripheral and coronary lesions. It is expected to experience strong growth as physicians adopt IVL-based calcium modification in complex procedures. This transaction is subject to customary closing conditions. Stryker and AVS will continue to operate as separate entities and proceed with business as usual until the transaction closes. About Stryker Stryker is a global leader in medical technologies and, together with our customers, we are driven to make healthcare better. We offer innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside our customers around the world, we impact more than 150 million patients annually. More information is available at www.stryker.com. About Amplitude Vascular Systems (AVS) Amplitude Vascular Systems (AVS) is a medical device company based in Boston, Mass., focused on treating severely calcified arterial disease. AVS is backed by global investors including BioStar Capital, Cue Growth Partners, and others. It was founded in 2017 by Hitinder Gurm, M.D., Interventional Cardiologist and Chief Clinical Officer at the University of Michigan, and Robert Chisena, Ph.D., Chief Technical Officer at AVS. More information is available at www.avspulse.com. Contacts For investor inquiries:Jason Beach, Vice President, Finance and Investor Relations at 269-385-2600 or jason.beach@stryker.com For media inquiries:Kim Montagnino, Vice President, Chief Communications Officer at 269-385-2600 or kim.montagnino@stryker.com