NEWTON, Mass. and SHEFAYIM, Israel, Aug. 10, 2026 /PRNewswire/ — AQUAPASS, developer of a noninvasive, kidney-independent therapy for fluid overload management in patients experiencing heart failure and chronic or end-stage kidney disease, announced completion of enrollment in its FDA…
Coronary/Structural Heart
Acarix Receives Regulatory Approval for the CADScor® System in the UAE (United Arab Emirates)
Approval opens market access across the UAE through commercial partner UniTech Solutions, bringing rapid, non-invasive coronary artery disease rule-out to point of care OKLAHOMA CITY, Aug. 10, 2026 /PRNewswire/ — Acarix AB (publ) today announced that the CADScor® System has received…
Total Flow Medical Receives FDA Clearance for Innovative Femoral Arterial Cannula for Cardiopulmonary Bypass
The TFA Cannula incorporates a distal balloon feature designed to allow blood flow to the cannulated limb during cardiopulmonary bypass VANCOUVER, BC, July 30, 2026 /CNW/ — Total Flow Medical, a medical device company developing solutions for extracorporeal circulation, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) […]
Cleerly and Allelica Partner to Launch a Polygenic Risk Score Test for Coronary Artery Disease
SAN FRANCISCO–(BUSINESS WIRE)– #AI–Cleerly, a leader in advanced cardiac imaging analysis, and Allelica, a precision medicine company specializing in multi-ancestry polygenic risk scores (PRS), today announced a partnership to launch the Cleerly Polygenic Cardiovascular Risk Score Test, powered by Allelica. The test gives physicians a new option to identify and evaluate individuals with an inherited predisposition to coronary plaque. The Cleerly Polygenic Cardiovascular Risk Score Test can be used
VDyne Announces First Patient Treated in TRIVITA US IDE Pivotal Study of the TriNovaTM Transcatheter Tricuspid Valve Replacement System
Maple Grove, Minnesota, July 29, 2026 – VDyne Inc. (“VDyne”), a privately held medical device company developing an innovative transcatheter tricuspid valve replacement (TTVR) system, today announced that the first patient has been enrolled and treated in the TRIVITA US IDE pivotal study of the TriNovaTM system. The randomized controlled […]
FDA Clears CorVista® System PCWP Add-On as a Noninvasive Test For Elevated Pulmonary Capillary Wedge Pressure
BETHESDA, Md. & TORONTO–(BUSINESS WIRE)–CorVista Health and Analytics For Life today announced FDA clearance of the CorVista® System with Pulmonary Capillary Wedge Pressure (PCWP) Add-On. The PCWP Add-On uses an AI-based algorithm to analyze physiological signals from patients with no history of elevated PCWP or prior right heart catheterization presenting with cardiovascular symptoms, such as chest pain, dyspnea, and fatigue, to indicate the likelihood of elevated PCWP. The clearance marks a
Humacyte Announces FDA Acceptance of IND for First-In-Human Clinical Study of CTEV for Coronary Artery Bypass Grafting
– Phase 2a study of CTEV in coronary artery bypass grafting (CABG) is expected to start this quarter –
Venus Medtech Announces Completion of Patient Enrollment in Pivotal China Trial for Venus-PowerX, the World’s First Fully Recoverable Self-Expanding Dry-Valve TAVR System
The PREVAILS study, now fully enrolled, marks a critical step toward simultaneous regulatory submissions in China and Europe for the next-generation TAVR system HANGZHOU, China, July 23, 2026 /PRNewswire/ — Venus Medtech (Hangzhou) Inc. (02500.HK) today announced that patient enrollment…
Ribo Discloses Positive Data from Vortosiran Phase 2a Trial – World’s First Clinical Data on siRNA-Mediated FXI Inhibition Following Multiple Dosing in Patients with Coronary Artery Disease
SHANGHAI and MOLNDAL, Sweden, July 22, 2026 /PRNewswire/ — Suzhou Ribo Life Science Co., Ltd. (06938.HK) and its subsidiary Ribocure Pharmaceuticals AB (collectively referred to as “Ribo”) today announce at China Pharmaceutical Innovation Conference (CPIC) in Shanghai, the positive…
Evogene Ltd. and ELEO Inc. Announce Collaboration to Develop Next-Generation Oral Small-Molecule PCSK9 Pathway Inhibitors for Hyperlipidemia and Cardiovascular Diseases
Collaboration combines Evogene’s AI-driven computational chemistry platform with ELEO’s proprietary biological capabilities to accelerate the discovery of novel oral therapies targeting a multi-billion-dollar cardiovascular market opportunity REHOVOT, Israel and DAEJEON, South Korea, July…



