Regulatory

Pharmazz, Inc. Announces US FDA Clearance for a Phase III Clinical Trial of Sovateltide (PMZ-1620) in Acute Cerebral Ischemic Stroke Patients

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, and induce neurovascular remodeling WILLOWBROOK, III., Feb. 13, 2023 /PRNewswire/ — Pharmazz, […]

Northeast Scientific Inc. awarded 510(k) clearance to reprocess the Eagle Eye Platinum RX Digital IVUS Catheter

WATERBURY, Conn., Feb. 06, 2023 (GLOBE NEWSWIRE) — Northeast Scientific Inc., the pioneers in reprocessing single use peripheral vascular catheters, announced this week it has received FDA 510(k) clearance for reprocessing the Philips IVUS Eagle Eye Platinum RX Digital catheter. CEO and Founder, Craig Allmendinger shared his thoughts on the […]

DiA Secures FDA Clearance for New AI-Powered Software, Assisting Ultrasound Users To Capture High-Quality Images

DiA Imaging Analysis’s LVivo IQS, a vendor-neutral AI-powered software provides cardiac ultrasound users with real-time image quality feedback while scanning BEER SHEVA, Israel, Feb. 6, 2023 /PRNewswire/ — DiA Imaging Analysis, a leading provider of advanced AI-based software solutions for ultrasound image analysis, announced today that the U.S. Food and Drug Administration (FDA) […]

Occlutech Continues its Progress in US FDA Study OCCLUFLEX – Enrolls First Patient in Europe

SCHAFFHAUSEN, CH / ACCESSWIRE / January 31, 2023 / Occlutech Holding AG Occlutech Holding AG (“Occlutech”), one of the world’s leading providers of minimally invasive structural heart disease devices, continues its progress in the US market. The first patient has now been enrolled in the global US study OCCLUFLEX in […]

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 failure, today announced the closing of a $75 million equity […]

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 and reverse the left ventricular remodeling process of progressive heart […]

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 that allows users to record their heart rhythm and check […]

Cadrenal Therapeutics (Nasdaq: CVKD) Granted FDA Fast Track Designation for Tecarfarin for Prevention of Systemic Thromboembolism of Cardiac Origin in Patients with End-Stage Renal Disease and Atrial Fibrillation

PONTE VEDRA, Fla., Jan. 23, 2023 /PRNewswire/ — Cadrenal Therapeutics (Nasdaq: CVKD), a biopharmaceutical company focused on developing tecarfarin, a clinical-stage novel cardiorenal therapy with orphan drug designation, announced today that the U.S. Food and Drug Administration (FDA) has granted a Fast Track designation to tecarfarin for the prevention of systemic thromboembolism, more commonly referred […]

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 to its premarket approval (PMA) application for the SurVeil™ drug-coated […]

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 life-threatening heart valve disease ABBOTT PARK, Ill., Jan. 17, 2023 /PRNewswire/ — […]