PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has extended the review of the New Drug Application (NDA) for mavacamten for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to April 28, 2022. The FDA notified Bristol Myers Squibb on […]
Regulatory
Cardialen Receives FDA Approval to Conduct Clinical Trial of Low-Energy Atrial Fibrillation Treatment
U.S. Food and Drug Administration approval of a clinical trial of Cardialen’s low-energy defibrillation and cardioversion therapy expands the number of leading clinical institutions evaluating its promising MultiPulse™ Therapy. MINNEAPOLIS–(BUSINESS WIRE)–Cardialen, Inc., has received approval from the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) to begin a […]
US FDA accepts supplemental New Drug Application and grants Priority Review for Jardiance® for adults with heart failure independent of left ventricular ejection fraction
If approved, Jardiance would be the first clinically proven treatment for adults across the full spectrum of heart failure regardless of ejection fraction RIDGEFIELD, Conn. and INDIANAPOLIS, Nov. 11, 2021 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Jardiance® (empagliflozin) 10 […]
HeartVista Receives FDA 510(k) Clearance to Deliver One Click MRI™ on Siemens Healthineers MRI Scanners
– FDA 510(k) Clearance Creates Multi-Vendor, One Click MRI™ Automation Platform to Increase Real-Time MRI Imaging Access and Accuracy for Patients – New AHA and ACC Guidelines, Making Cardiac MRI a Class I Recommendation for Chest Pain, Will Increase CMR Use to Widely Impact the Practice of Cardiology PALO ALTO, Calif.–(BUSINESS WIRE)–HeartVista, […]
Vektor Medical Receives FDA Clearance for vMap™, First Technology Designed to Identify Arrhythmia Hot Spots Anywhere in Heart in Minutes Using Only ECG Data
Non-Invasive Technology Requires No Vests, CT or MRI Imaging, or Invasive Mapping SAN DIEGO–(BUSINESS WIRE)–Vektor Medical, Inc. today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for its novel computational ECG mapping system, vMap™. vMap is designed to map potential arrhythmia sources (hot spots) associated with stable or unstable […]
DiaMedica Therapeutics Announces Addition of Stroke Recurrence as a Second Independent Primary Endpoint in ReMEDy2 Phase 2/3 AIS Trial
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 accepted and concluded that DiaMedica “may proceed” with the proposed clinical investigation using its amended protocol adding stroke […]
FDA Clears 12 New XO Cross Microcatheters
12 new hydrophilic-coated micro and support catheters cleared by FDA for broad use in the peripheral vasculature. PARK CITY, Utah, Nov. 2, 2021 /PRNewswire/ — Transit Scientific announced the FDA clearance of new hydrophilic-coated XO Cross Microcatheters for guidewire support, exchange, and contrast media injection in the peripheral vasculature. “The XO Cross devices […]
IMPULSE DYNAMICS RECEIVES FDA APPROVAL TO MODIFY LABELING FOR OPTIMIZER SMART MEDICAL DEVICES
FDA Authorizes Removal of “NSR” From Indications for Use MARLTON, N.J., Oct. 26, 2021 (GLOBE NEWSWIRE) — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), today announced that the U.S. Food and Drug Administration approved a modification of labeling for […]
Stealth BioTherapeutics Receives Refusal to File Letter from the FDA
BOSTON, Oct. 20, 2021 /PRNewswire/ — Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced that it received a Refusal to File letter from the United States Food and Drug Administration (FDA) regarding Stealth’s New Drug Application […]
FEops HEARTguide Authorized by FDA for Unprecedented LAAo Planning Capabilities
GENT, Belgium–(BUSINESS WIRE)–FEops today announced that it received De Novo authorization from the U.S. Food and Drug Administration (FDA) for FEops HEARTguide™ pre-operative planning of left atrial appendage occlusion with the Boston Scientific WATCHMAN™ device*. FEops HEARTguide™ will enable physicians to virtually model clinical scenarios with different implant positions and sizes […]
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