Regulatory

Anumana Receives U.S. FDA Breakthrough Device Designation for its Cardiac Amyloidosis Algorithm

Developed in collaboration with Mayo Clinic, with support from Pfizer, this ECG-AI algorithm aims to aid physicians in earlier identification of cardiac amyloidosis CAMBRIDGE, Mass.–(BUSINESS WIRE)–Anumana, Inc., a leading AI-driven health technology company, has received Breakthrough Device Designation from the […]

DiaMedica Therapeutics Announces that the FDA Has Removed The Clinical Hold On DM199 Phase 2/3 Trial For Ischemic Stroke

MINNEAPOLIS–(BUSINESS WIRE)–DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, announced today that the U.S. Food and Drug Administration (FDA) has removed the clinical hold placed on the investigational […]

Owlet Announces FDA-Clearance of the First Prescription Pulse Oximetry Sock for Infants

LEHI, Utah–(BUSINESS WIRE)–Owlet (NYSE: OWLT, “the Company”), the pioneer of smart baby monitoring, announces clearance from the U.S. Food and Drug Administration (“FDA”) of BabySat™, the first medical pulse-oximetry device featuring its advanced, wire-free sock design. Owlet is a leader in infant […]

FDA Approves Innovative 4D Flow MRI Blood Flow Analysis Software from Cardio Flow Design Inc. (Japan) – Enhance Cardiovascular Diagnostic Accuracy

SAN FRANCISCO–(BUSINESS WIRE)–The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis. The FDA approval is significant as it recognizes the safety and effectiveness of iTFlow® in analyzing blood flow through 4D Flow MRI […]

U.S. Food and Drug Administration Approves Addition of Positive Data from Phase 3 VALOR-HCM Study to CAMZYOS® (mavacamten) Label

CAMZYOS is the first and only FDA-approved cardiac myosin inhibitor that specifically targets the underlying source of obstructive HCM VALOR-HCM is the second Phase 3 trial in which CAMZYOS demonstrated significant improvement in symptoms of obstructive HCM June 15, 2023 08:23 PM Eastern […]

Avertix’s Guardian™ System, First and Only FDA-Approved Implantable Heart Attack Detection and Warning System, Now Available at AdventHealth Orlando

AdventHealth Orlando performs their first implant of Guardian™ System, revolutionizing cardiac care in Central Florida EATONTOWN, N.J. and ORLANDO, Fla., June 13, 2023 (GLOBE NEWSWIRE) — Avertix Medical, Inc. (“Avertix” or the “Company”), formerly known as Angel Medical Systems, Inc., a company […]

Rocket Pharmaceuticals Receives FDA Fast Track and Orphan Drug Designations for RP-A601 Gene Therapy for PKP2 Arrhythmogenic Cardiomyopathy (ACM)

CRANBURY, N.J.–(BUSINESS WIRE)–Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a leading late-stage biotechnology company advancing an integrated and sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast […]

Endologix Receives FDA Approval of the DETOUR™ System to Treat Long Complex Superficial Femoropopliteal Lesions in Patients with PAD

IRVINE, Calif.–(BUSINESS WIRE)–Endologix LLC, a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, announced today that the U.S. Food and Drug Administration (FDA) has granted approval for the DETOUR System […]