New Clinical Data Supports Use of Biobeat ABPM Cuffless-Monitor as Reliable and Accurate Solution for Out-of-Clinic Blood Pressure Monitoring PETAH TIKVA, Israel, May 26, 2021 /PRNewswire/ — Biobeat, a global leader in wearable remote patient monitoring solutions for the healthcare continuum, announced today the launch of its new wearable and continuous ambulatory blood pressure […]
Other News
Mezzion’s New Drug Application (“NDA”) for its Orphan Drug Udenafil for the Treatment of Single Ventricle Heart Disease (“SVHD”) has been Accepted for Filing by the FDA
SEOUL, South Korea, May 25, 2021 /PRNewswire/ — Mezzion Pharma Co., Ltd. (140410.KQ) is pleased to announce today that it has received notice from the FDA that its NDA submitted on March 26, 2021 for the use of udenafil to treat SVHD patients who have undergone Fontan palliation is sufficiently complete to permit a substantive review […]
Neovasc Receives NASDAQ Notification Regarding Minimum Bid Price Deficiency
VANCOUVER and MINNEAPOLIS, May 25, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) announced today that it has received written notification (the “Notification Letter”) from The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it is not in compliance with the minimum bid price requirement set forth […]
Hello Heart Completes $45M Investment to Fuel Growth and Expand Digital Heart Health
Series C financing was led by IVP and includes existing investors MENLO PARK, Calif.–(BUSINESS WIRE)–Hello Heart, the best-in-class heart health digital therapeutics solution, has completed a $45 million Series C led by IVP. IVP is a top later-stage partner for hypergrowth companies including Coinbase, Lyra Health, Slack, Snap, Twitter, and […]
SIRONA – The world’s first and largest RCT comparing Sirolimus V/S Paclitaxel balloon for the treatment of Peripheral Arterial Disease progresses rapidly
JENA, Germany, May 24, 2021 /PRNewswire/ — Concept Medical Inc., focused on vascular intervention drug delivery devices, releases status updates of SIRONA Randomized Control Trial (RCT) which compares head-to-head, SIROlimus versus Paclitaxel Drug-Eluting BallooN Angioplasty in femoropopliteal arterial diseases (SIRONA). SIRONA is the world’s first RCT investigating the use of Sirolimus drug coated balloon (DCB) (MagicTouch PTA – Concept Medical) […]
Foldax Announces Successful First Human Use of Tria Biopolymer Mitral Heart Valve
Second Product from Tria Biopolymer Valve Portfolio to Move into Human Study SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced the successful first-in-human use of its biopolymer Tria™ heart valve in surgically replacing a diseased mitral valve. The first case was performed by David Heimansohn, MD, at Ascension St. Vincent Hospital, […]
JenaValve Technology Receives CE Mark for its Trilogy™ TAVI System for the Treatment of Aortic Regurgitation and Aortic Stenosis
IRVINE, Calif., May 25, 2021 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer, and manufacturer of differentiated transcatheter aortic valve implantation (TAVI) systems (also referred to as TAVR, or transcatheter aortic valve replacement) for the treatment of aortic valve disease, today announced that it has received CE Mark for its TrilogyTM Heart […]
Emboline Raises over $55 Million in Series D Funding for Pivotal FDA Clinical Study and Market Launch of the Emboliner™ Embolic Protection Catheter to Minimize Stroke Risk from TAVR
Financing led by Matrix Capital Management with significant investment from an undisclosed strategic investor — Eric Xiao of Matrix Capital Management to join the Emboline Board of Directors SANTA CRUZ, Calif., May 25, 2021 /PRNewswire/ — Emboline, Inc., a privately held medical device company focused on reducing stroke and other damage caused by embolic […]
Procyrion Announces Successful First-in-Human Cases in Cardiorenal Syndrome (CRS) Patients with Aortix™ Percutaneous Mechanical Circulatory Support Device
Pilot CRS Study to Evaluate Performance of Novel Aortix device in Australia and the U.S. HOUSTON, May 25, 2021 /PRNewswire/ — Procyrion, Inc., a medical device company dedicated to improving outcomes for patients with cardiac and renal impairment, announced today successful treatment of the first patients in the company’s pilot trial to evaluate […]
iRhythm® Technologies Continues to Fuel Innovation in Cardiac Monitoring and Unveils Two FDA Clearances for Superior Patient Care
The new Zio® monitor is designed to significantly improve patient comfort, while enhanced AI capabilities raise the bar on cardiac arrhythmia detection SAN FRANCISCO, May 24, 2021 (GLOBE NEWSWIRE) — iRhythm Technologies, Inc. (NASDAQ: IRTC), a leading digital healthcare solutions company focused on the advancement of cardiac care, today announced […]



