LexaGene Holdings, Inc., (TSX-V: LXG; OTCQB: LXXGF) (the “Company”), a molecular diagnostics company that develops fully automated rapid pathogen detection systems, is pleased to announce that it has started a series of studies required by the FDA for Emergency Use Authorization (EUA) testing for its COVID-19 assay in a point-of-care (POC) environment using its fully automated MiQLab™ system.
Interscope, Inc. and Micro-Tech Endoscopy signed a partnership agreement focused on the distribution of Interscope's unique EndoRotor System for gastroenterology.
The following quote is attributed to Amber McCoig, D.V.M., M.P.H., deputy director of the FDA's Center for Veterinary Medicine (CVM) Division of Compliance
FDA Sets PDUFA Target Action Date of June 1, 2021
The First and Only System Designed and Indicated for DEN now Available in the United States and Europe
Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce an update on the Company’s U.S. Food & Drug Administration (“FDA”) Phase 3 clinical trial (the “Study”) to evaluate the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19.
The U.S. Food and Drug Administration issued five warning letters to companies for selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts
Occlutech, a privately-held company, announced today that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for Pulmonary Arterial Hypertension (PAH).
Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts
The following is attributed to FDA Commissioner Stephen M. Hahn, M.D.
Test system is authorized for at-home sample collection with laboratory test processing
Novel radial artery occlusion device removes the guesswork from achieving Patent Hemostasis
Ensemble Orthopedics Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its Ensemble CMC Implant. The Ensemble CMC was designed to treat patients with early-stage osteoarthritis of the carpometacarpal (CMC) joint using a minimally invasive, simple surgical procedure.
3B Medical announced receiving Emergency Use Authorization from the FDA to permit use of Lumin, a UVC system, on N95 respirators during the COVID-19 pandemic.
COVID-19 Testing Efforts Immediately Expanded with Scalable Platform
