Author: Ken Dropiewski

FDA Grants the Doraya AHF Catheter Breakthrough Designation

NETANYA, Israel, July 14, 2020 /PRNewswire/ — Revamp Medical, a medical device company developing a percutaneous device for the treatment of acute heart failure (AHF), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the Doraya™ device. The Doraya is a temporary catheter, placed in the […]

HD Medical Awarded FDA Clearance For HD Steth

Intelligent Stethoscope with Integrated ECG delivers Instant Cardiac Insights SANTA CLARA, Calif.–(BUSINESS WIRE)–HD Medical, Inc. of Silicon Valley today announces that its flagship product, HD Steth, has received FDA clearance for all three product classification codes of DQD, DQC and DPS for Electronic Stethoscope, Phonocardiograph and Electrocardiograph combined into one device. HD Steth utilizes […]

SINOMED® Completes One-Year Follow-Up of the PIONEER-III European, US and Japanese Trial of the BuMA Supreme® Coronary Drug-Eluting Stent

TIANJIN, China, July 13, 2020 /PRNewswire/ — SINOMED, a developer of innovative neuro- and cardiovascular technologies, announced the completion of the 1-year follow-up in the PIONEER-III, randomized global trial evaluating the BuMA Supreme Drug-Eluting Coronary Stent (DES). Once completed, the company plans to submit the data to the U.S. Food and Drug […]

Neovasc Announces Circulatory System Devices Panel Meeting Date for Neovasc Reducer™ Device

VANCOUVER and MINNEAPOLIS, July 09, 2020 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — Neovasc, Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), announced today that it has been informed by the U.S. Food and Drug Administration (FDA) that the Circulatory System Devices Panel of the Medical Devices Advisory Committee will review the premarket approval application (PMA) for […]

Somalogic and NEC Solution Innovators Announce Launch of Foneslife Corporation

New company will deliver blood tests based on large-scale protein measurements to people in Japan BOULDER, Colo., July 09, 2020 (GLOBE NEWSWIRE) — SomaLogic, Inc. and NEC Solution Innovators, Ltd. of Japan, a subsidiary of NEC Corporation, announced today the establishment of FonesLife Corporation, a new Tokyo-based company that will […]

Shockwave Announces Decisions From the U.S. Patent and Trademark Office on Inter Partes Review Proceeding

SANTA CLARA, Calif., July 08, 2020 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, announced today that the company received the initial rulings related to two of the inter partes review (IPR) cases that were initiated by […]

Philips and BioIntelliSense form strategic collaboration to enhance remote patient monitoring for at-risk patients from the hospital into the home

July 9, 2020 Philips integrates the BioIntelliSense FDA-cleared BioSticker™ sensor as part of its remote patient monitoring solutions for patients outside the hospital Multi-parameter sensors aid monitoring across multiple chronic conditions with medical-grade vital signs for physicians to remotely track core symptoms, including COVID-19   Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, […]

Anteris Technologies to Host TAVR Key Opinion Leader Symposium Moderated by Matt Miksic of Credit Suisse on July 20th, 2020

Next Generation Technologies for the era of TAVR in Younger Low-Risk Patients with Aortic Stenosis BRISBANE, Australia and EAGAN, Minn., July 09, 2020 (GLOBE NEWSWIRE) — Anteris Technologies Limited (ASX:AVR), a structural heart company advancing the DurAVR™ valve, a novel aortic valve replacement solution, announced today that it will host a […]

AliveCor Expands Telemedicine Services to Support Heart Care at Home

New subscription service, KardiaCare, helps users manage heart conditions, understand symptoms, and reduce risk for heart disease MOUNTAIN VIEW, Calif., July 9, 2020 /PRNewswire/ — AliveCor, the leader in personal ECG technology, today announced the launch of KardiaCare, a digital health subscription service that offers members the control and convenience of managing heart […]