Other News

Novo Nordisk A/S: Semaglutide 2.4 mg reduces the risk of major adverse cardiovascular events by 20% in adults with overweight or obesity in the SELECT trial

Bagsværd, Denmark, 8 August 2023 – Novo Nordisk today announced the headline results from the SELECT cardiovascular outcomes trial. The double-blinded trial compared subcutaneous once-weekly semaglutide 2.4 mg with placebo as an adjunct to standard of care for prevention of major adverse cardiovascular events (MACEs) over a period of up to five years. […]

Shockwave Medical Reports Second Quarter 2023 Financial Results

SANTA CLARA, Calif., Aug. 07, 2023 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (Nasdaq: SWAV), a pioneer in the development and commercialization of transformational technologies for the treatment of cardiovascular disease, today reported financial results for the three months ended June 30, 2023. Recent Highlights Recognized revenue of $180.2 million for […]

HeartBeam Appoints Deborah Castillo as Vice President of Regulatory Affairs

SANTA CLARA, Calif.–(BUSINESS WIRE)–HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology company that has developed the first and only credit card-size 3D-vector electrocardiogram (VECG) platform for patient use at home, allowing for the creation of rich data for AI, today announced the appointment of Deborah Castillo, PhD, as Vice President of Regulatory […]

Orchestra BioMed™ Granted FDA Approval of IDE for U.S. Pivotal Study of Virtue® Sirolimus AngioInfusion Balloon™ in Patients with Coronary In-Stent Restenosis

NEW HOPE, Pa., Aug. 08, 2023 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the U.S. Food and Drug Administration (the “FDA”) granted investigational device exemption (“IDE”) approval with conditions […]

Nyra Medical names Lori Chmura as Chief Executive Officer

ATLANTA, Aug. 8, 2023 /PRNewswire/ — Nyra Medical, an innovative medical device company developing a next generation transcatheter mitral valve repair technology, announced the appointment of Lori Chmura as Chief Executive Officer and Board Director. Lori succeeds Dr Murali Padala, who founded the company and will assume the role of Chief Scientific Officer.   Nyra […]

Game-changing Indian MRI Scanner Launched: Targets 6 billion People without Access to Cutting-edge Imaging Technologies

NEW DELHI, Aug. 7, 2023 /PRNewswire/ — In a groundbreaking development, India-based company Voxelgrids has launched an advanced and affordable MRI scanner with the potential to revolutionize healthcare accessibility not only in India but also worldwide. With funding from BIRAC (Biotechnology Industry Research Assistance Council), an institution set up by the Department of Biotechnology (DBT), Government […]

VenusP-Valve granted IDE approval for clinical trial, unveiling a new chapter for Chinese valve solutions globally

HANGZHOU, China, Aug. 6, 2023 /PRNewswire/ — Recently, Venus Medtech (Hangzhou) Inc. (“Venus Medtech”), a leading provider of integrated solutions for transcatheter structural heart valvular therapies in China, announced the Investigational Device Exemption (IDE) full approval for its in-house developed VenusP-Valve from the U.S. Food and Drug Administration (FDA). VenusP-Valve, thus, has become the […]

Avinger Announces Conversion of 12% of CRG Term Debt into Equity

REDWOOD CITY, CA / ACCESSWIRE / August 4, 2023 / Avinger, Inc. (Nasdaq:AVGR), a commercial-stage medical device company developing and marketing the first and only intravascular image-guided, catheter-based systems for diagnosis and treatment of vascular disease, today announced the conversion of approximately 12% of its existing debt with entities affiliated with CRG Partners III […]

MCRA Aids Surmodics in Obtaining FDA Pre-Market Approval for Cardiovascular Drug-Coated Balloon

WASHINGTON, Aug. 7, 2023 /PRNewswire/ — MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance, Cybersecurity, Quality Assurance, and Japan Distribution Logistics (DMAH) is pleased to announce its role in the successful […]