Regulatory

Humacyte’s Human Acellular Vessel™ (HAV™) Receives FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation for Urgent Arterial Repair Following Vascular Trauma

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 […]

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 […]

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 […]