The Latest Cardiac and Vascular News
First clinical gene therapy program for PKP2-ACM, a devastating inherited heart disease affecting approximately 50,000 people in the U.S. and EU Robust preclinical proof of concept studies showed RP-A601 decreased arrhythmias and increased survival in the PKP2 knockout mouse model Initiating Phase 1 trial start-up activities and rapidly working towards first […]
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 at commercial scale, has been recently granted the U.S. Food […]
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 failure therapy Ghent, Belgium – 02 May 2023 – Sequana Medical NV (Euronext […]
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 company with a mission to discover, develop and deliver potentially […]
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) approval of its Micra™ AV2 and Micra™ VR2, the next […]
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 the third IDE approval for Concept Medical’s Sirolimus Coated Balloon […]
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 target of an initial product market launch by the end […]
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) clearance from the U.S. Food & Drug Administration (FDA) for […]
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, the CONNEQT Pulse (Pulse), has received 510(k) clearance from the […]
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 analyse echocardiograms and detect the presence of cardiac amyloidosis, a […]
