The primary endpoint is the proportion of patients with a good outcome as a modified Rankin Score (mRS) of 0-2 on day 90 post-randomization Sovateltide is an endothelin-B receptor agonist that has been shown to increase blood flow, inhibit apoptosis, […]
Tag: FDA
Alleviant Medical Closes $75M in Financing; Receives FDA IDE Approval for Pivotal Clinical Trial
Novel technology shows potential to treat heart failure—leading cause of hospitalizations worldwide—with less invasive approach January 26, 2023 09:00 AM Eastern Standard Time AUSTIN, Texas–(BUSINESS WIRE)–Alleviant Medical, Inc., a privately-held medical device company developing a no-implant interatrial shunt for heart […]
FDA Agrees to Expanded Access Program for the BioVentrix® Revivent TC® System for the Treatment of Ischemic Heart Failure
Treatment IDE Will Provide Opportunity to Treat Additional Patients in the US SAN RAMON, Calif., Jan. 24, 2023 /PRNewswire/ — BioVentrix®, Inc., a privately held medical device company focused on the development of less invasive therapies to directly treat the dilated left ventricle […]
Understand your body better with the new ECG App from Garmin
FDA-cleared and clinically-validated app lets Venu 2 Plus customers record an ECG and check for signs of atrial fibrillation right from their smartwatch OLATHE, Kan., Jan. 24, 2023 /PRNewswire/ — Garmin (NYSE: GRMN) today announced the ECG App1, an FDA-cleared app for the Venu® 2 Plus smartwatch […]
Surmodics Provides Regulatory Update Related to its FDA Premarket Approval Application for the SurVeil™ Drug-Coated Balloon
EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced it has received a letter from the U.S. Food and Drug Administration (FDA; the Agency) related […]
Abbott Receives FDA Approval for Navitor™, a Next-Generation TAVI System Designed to Treat Aortic Stenosis
Abbott’s new Navitor device features advancements to improve patient care, including reducing or eliminating risk of blood leakage around valve implant Transcatheter aortic valve implantation (TAVI) offers minimally invasive alternative to surgery for people with aortic stenosis, a common and […]
MedAlliance SELUTION SLR is the first DEB to receive coronary de novo IDE approval, its fourth FDA IDE DEB Approval
GENEVA, Jan. 10, 2023 /PRNewswire/ — SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of coronary de novo lesions. This comes less than eight months after the company received […]
CardiacSense receives FDA Clearance for Medical Watch
CardiacSense was granted FDA clearance for Beat-by-Beat Heart Rate, and Oxygen Saturation (SpO2) Proprietary sensors enable highly accurate and reliable measurement of vital signs (99% sensitivity and specificity for beat-by-beat heart rate when comparted to Holter Monitor) CardiacSense plans to […]
Biobeat Remote Patient Monitoring Devices and Platform Receive Additional FDA Clearances for Stroke Volume and Cardiac Output
PETAH TIKVA, Israel, Jan. 9, 2023 /PRNewswire/ — Biobeat, a global leader in wearable remote patient monitoring solutions for the healthcare continuum, announced today that its wearable remote patient monitoring devices have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to […]
Cardiovascular Systems, Inc. Announces FDA 510(k) Submission of Innova Vascular, Inc.’s Thrombectomy System
System includes mechanical and aspiration thrombectomy devices to treat peripheral vascular disease ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, […]