Author: Ken Dropiewski

FDA Grants Breakthrough Device Designation to Ascyrus Medical Dissection Stent (AMDS)

Ascyrus Medical receives Breakthrough Device Designation from the FDA for its Ascyrus Medical Dissection Stent (AMDS) to treat acute Type A aortic dissections. BOCA RATON, FLA. (PRWEB) AUGUST 14, 2019 Ascyrus Medical announced today that it has received Breakthrough Device Designation from the FDA for its Ascyrus Medical Dissection Stent (AMDS) […]

V-Wave’s Interatrial Shunt Receives FDA Breakthrough Device Designation for Heart Failure

CAESAREA, Israel, Aug. 15, 2019 /PRNewswire/ — V-Wave Ltd., a privately held medical device company developing novel implantable interatrial shunt devices, today announced that the U.S. Food and Drug Administration (FDA) has just granted the company a Breakthrough Device Designation for its interatrial shunt for Heart Failure (HF). V-Wave’s minimally invasive, implanted interatrial […]

Renovacor Closes $11 Million Series A Financing to Advance First Gene Therapy for a Rare Cardiovascular Disease

– Funding supports preclinical development through IND submission for its BAG3 gene therapy, the first gene replacement product for genetic forms of dilated cardiomyopathy – Company announces leadership team and board of directors with leading scientists, physicians and experienced venture investors in cardiovascular and gene therapy fields August 14, 2019 10:11 AM […]

Silk Road Medical Announces Closing of Follow-on Public Offering and Full Exercise of the Underwriters’ Option to Purchase Additional Shares

SUNNYVALE, Calif., Aug. 13, 2019 (GLOBE NEWSWIRE) — Silk Road Medical, Inc. (Nasdaq: SILK) (“Silk Road Medical”), a company focused on reducing the risk of stroke and its devastating impact, today announced the closing of a public offering of 4,200,000 shares of its common stock sold by selling stockholders, and […]

DynoSense Corp. Announces FDA Approval of Its Cloud Based Vital Signs Measurement System

SAN JOSE, Calif., Aug. 13, 2019 /PRNewswire/ — DynoSense Corp. announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance for its patented Vital Signs Measuring System, the world’s first most integrated and cloud-based vital signs measuring and recording platform. Its unique worldwide patented and award-winning design is as simple […]

Windtree Announces FDA Fast Track Designation for Istaroxime

WARRINGTON, Pa., Aug. 13, 2019 /PRNewswire/ — Windtree Therapeutics, Inc. (OTCQB: WINT), a biotechnology and medical device company focused on developing drug product candidates and medical device technologies to address acute cardiovascular and pulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for istaroxime for the […]

Cardiovascular Systems, Inc. to Feature LIBERTY 360° Three-year Outcomes Data at 2019 Amputation Prevention Symposium

Company introduces Diamondback 360° Exchangeable Series to treat multi-level PAD ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today announced that the three-year outcomes from its LIBERTY 360° study will […]

Philips’ response to updated FDA letter to healthcare providers on paclitaxel devices to treat peripheral artery disease

Amsterdam, The Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced its response to the U.S. Food and Drug Administration’s (FDA) Letter to Health Care Providers regarding treatment of peripheral artery disease (PAD) in the superficial femoropopliteal artery (SFA) with paclitaxel-coated devices.    Importantly, the FDA recommendation continues […]