HAV granted second RMAT designation by the FDA RMAT will support Humacyte’s lead indication in Vascular Trauma DURHAM, N.C., May 04, 2023 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue […]
Regulatory
Sequana Medical announces FDA clearance of IND application for DSR® 2.0 for treatment of congestive heart failure
MOJAVE study on track to start in Q2 2023 as planned, with initial data by year-end Randomized, controlled study in US seeking to confirm strong efficacy data seen in RED DESERT and SAHARA studies DSR well positioned as disease-modifying heart […]
Tenaya Therapeutics Receives FDA Fast Track Designation for TN-201
TN-201 Being Developed for the Potential Treatment of MYBPC3-associated HCM Dosing in Phase 1 Clinical Trial Expected to Commence in Q3 2023 SOUTH SAN FRANCISCO, Calif., May 02, 2023 (GLOBE NEWSWIRE) — Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology […]
Medtronic receives FDA approval for its next generation Micra leadless pacing systems
New pacemakers offer 40% more battery life,1 extend Medtronic legacy of pacing leadership DUBLIN – May 1, 2023 – Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has received U.S. Food and Drug Administration (FDA) […]
Concept Medical received IDE approval to investigate safety and efficacy of its MagicTouch Sirolimus Coated Balloon Catheter for the treatment of small coronary artery disease
TAMPA, Fla., May 1, 2023 /PRNewswire/ — The US FDA has granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc’s novel MagicTouch Sirolimus Coated Balloon (SCB) for the treatment of Small Vessels (SV) in coronary arteries. US FDA, on the 25th of April 2023, granted […]
Casana Receives FDA Clearance for Heart Health Smart Toilet Seat
Casana obtained FDA clearance for measuring Heart Rate (HR) and Oxygen Saturation (SpO2) Sensors embedded in the toilet seat enable effortless measurement of these vital signs Casana will pursue subsequent filings, including Systolic and Diastolic Blood Pressure (BP), with the […]
Avinger Receives 510(k) Clearance for Tigereye ST Image-Guided CTO Crossing System
REDWOOD CITY, CA / ACCESSWIRE / April 26, 2023 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of vascular disease, today announced the company has received 510(k) […]
CardieX Receives FDA 510(K) Clearance for a World-First Vascular Biometric Monitor – the CONNEQT Pulse
The world’s first, customizable vascular biometric monitor has received regulatory clearance to provide medical grade arterial heart health metrics to patients and clinicians IRVINE, Calif., April 26, 2023 /PRNewswire/ — CardieX Limited (ASX: CDX) (CardieX, the Company), today announced its new arterial health monitor, […]
Ultromics granted FDA Breakthrough Device Designation for AI-enhanced Cardiac Amyloidosis detection
OXFORD, England, April 26, 2023 /PRNewswire/ — Ultromics, a leader in the field of artificial intelligence-powered diagnostics for heart failure, has been granted FDA Breakthrough Device Status for its AI-enhanced platform for detecting cardiac amyloidosis. The platform, EchoGo Amyloidosis, uses artificial intelligence to […]
Abbott’s Life Support System Receives New FDA Clearances to Help Doctors Treat More Critically Ill Patients
Abbott’s CentriMag™ Blood Pump, previously cleared for use up to six hours, now can be used to provide longer-term life support to critically ill patients, providing doctors more time to make critical care decisions Abbott’s CentriMag™ Pre-connected Pack, which combines […]