CAPTION HEALTH: FDA Grants Caption Health Landmark Authorization for First AI-Guided Image Acquisition System
Caption Guidance™ uses artificial intelligence to empower medical professionals without specialized training to perform cardiac ultrasound
Caption Guidance™ uses artificial intelligence to empower medical professionals without specialized training to perform cardiac ultrasound
U.S. Food and Drug Administration authorized marketing of software to assist medical professionals in the acquisition of cardiac ultrasound, or echocardiography, images.
“Genome editing is a groundbreaking technology used to introduce intentional genomic alterations in animals and has the potential to improve human and animal health, animal well-being and to enhance food production and quality. It is paramount, however, that as we move forward, we maintain standards of safety and effectiveness.
CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), today announced that the company has submitted a pre-market approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) for the HeartLight X3 Endoscopic Ablation System for the treatment of AFib.
Koura's Zephex® 152a facilitates greater than 90% reduction in inhaler carbon footprints compared to current MDIs
The U.S. Food and Drug Administration and the Federal Trade Commission today signed a joint statement regarding enhanced collaboration in support of a robust marketplace for biological products, including the critical adoption of biosimilars and interchangeable products.
Interactive tool offers information on ARVs eligible for purchase under the President’s Emergency Plan for AIDS Relief program
Elixicure's Over-The-Counter Drug Registration has been Certified by the U.S. Food and Drug Administration (FDA) for its Elixicure CBD-Infused Pain Relief products following a successful year-long process, announced Elixicure Chief of Business Development Yaniv Kotler.
Sony Electronics has received FDA 510(k) clearance from the Food and Drug Administration for the company's NUCLeUS™ Operating Room, Imaging Management and Collaboration Control platform.
GOJO took immediate action to respond to FDA claim requirements after receiving a warning letter from the agency on January 17.
The American Association of Orthodontists (AAO) - in the interests of the health, safety, and well-being of patients seeking orthodontic care - reports that on January 6, nine members of the U.S. House of Representatives authored a letter to the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) "to express [their] concern regarding SmileDirectClub."
Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has granted priority review for the New Drug Application (NDA) for selpercatinib (LOXO-292), for the treatment of patients with advanced RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer.
American Regent, Inc. announced the introduction of FDA approved Zinc Sulfate Injection, USP.
An effortless patient experience combined with actionable clinical intelligence to bring medical-grade care to the home
The Access PCT strengthens industry's most extensive portfolio of in-vitro diagnostic testing for sepsis identification and management
Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) seeking approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and for the treatment of bipolar I disorder.
Minneapolis FDA delays reporting to the patients in Chicago the non-exempt testing of the device affecting 667 patients
Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, today announced the receipt of formal acceptance from the U.S. Food and Drug Administration (FDA) to proceed with its CNM-Au8 as one of the first three drug regimens in the HEALEY ALS Platform Trial being conducted by the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital.
Regulatory approval enables company to expand reach of at-home kits, empowering consumers nationwide to take control of their health
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven" or the "Company"), a biopharmaceutical company with multiple late-stage neuroscience drug candidates in development, announced today that the U.S. Food and Drug Administration (FDA) has notified its collaborators at the Sean M. Healey & AMG Center for Amyotrophic Lateral Sclerosis (ALS) at Massachusetts General Hospital (MGH) that they may proceed with clinical investigation of verdiperstat, Biohaven's novel myeloperoxidase (MPO) inhibitor, in ALS.