, /PRNewswire/ — Copan Diagnostics, a leader in Clinical Microbiology automation solutions, has announced the third FDA clearance for its innovative pre-analytical processor, Colibrí™. The automated ID/AST preparation instrument is a key…
Category: FDA
MEDICAL IP Received US FDA 510(k) Clearance for DeepCatch, AI Software for Whole-Body Composition CT Quantification
The world’s first FDA cleared solution that automatically analyzes bone, muscle, visceral fat, subcutaneous fat, internal organ, and central nervous system in whole-body CT Validation using multi-site and multi-racial CT data in…
Cognixion Receives FDA Breakthrough Device Designation for its Brain-Computer Interface with Augmented Reality for Assistive Communication
U.S. FDA Breakthrough Device designations are granted to expedite the review of technologies with the potential to greatly impact those suffering from life threatening and debilitating diseases. Cognixion ONE Axon aims to…
Formus Labs, Pioneering Developer of AI-Powered 3D Orthopedic Surgery Planning Technology, Receives FDA Clearance
Formus combines AI and biomechanics to empower orthopedic surgeons with fully interactive 3D surgical plans that optimize the preoperative (pre-op) planning process , /PRNewswire/ — Formus Labs today announced it has received 510(k) clearance…
Alio Becomes World’s First Non-invasive Potassium Monitor
Company secures second FDA clearance for its remote patient monitoring platform, adding three new metrics , /PRNewswire/ — Alio, Inc., a medical technology company reinventing the management of chronic disease, announced its…
MCRA Assists TriReme Medical with Obtaining FDA Premarket Approval of Cardiovascular Balloon Catheter
, /PRNewswire/ — MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare…