amg International GmbH, a Q3 Medical Devices Ltd Company, Receives European CE Mark Approval for UNITY-B™ Biodegradable Stent
amg International GmbH ("amg" or the "Company"), a wholly owned subsidiary of Dublin, Ireland based Q3 Medical Devices Limited (Q3), further establishes its leadership role in...
U.S. FDA Approves Aptar’s Proprietary Activ-Film™ Technology for use with Rechargeable Implantable Neurostimulator
Sophisticated implantable medical device for urinary and bowel dysfunction leverages Aptar’s groundbreaking 3-Phase Activ-Polymer™ technology to control moisture and extend use life.Aptar CSP Technologies,...
CorVent Medical Secures CE Mark Approval For Its Critical Care RESPOND-19™ Ventilator
CorVent Medical, a private medtech company focused on developing versatile, lifesaving ventilators for critical care, announced that it has received CE Mark approval and...
Biorez Granted FDA 510(k) Clearance of BioBrace Soft Tissue Scaffold
Biorez received FDA 510(k) clearance to market two sizes of the BioBrace™ Implant. This new biocomposite soft tissue scaffold is intended to be used in a...
Acutus Medical Announces CE Mark Approval for Suite of Next Generation EP Products in Europe
Expanded and Product Portfolio Strengthens Offering in Access and Therapy GuidanceAcutus Medical, Inc. (“Acutus”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the...
Neuromodulation treatment for chronic migraine given CE mark
Chordate Medical Holding AB, a Swedish medtech company, has developed and patented an innovative treatment method: K.O.S. The company's existing EC-certificate for K.O.S has...
Orthofix Announces FDA Clearance of the OrthoNext Digital Platform for the JuniOrtho Plating System
Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and orthopedics focus, today announced expansion of its pediatric offerings with the U.S. Food...
Gut health startup Viome gets breakthrough device designation for mRNA analysis tool
Viome has adapted its technology to search for the presence of oral squamous cell carcinoma and oropharyngeal cancer in users’ saliva samples.Viome, maker of at-home...
Bigfoot Biomedical wins FDA clearance for smart insulin pen cap system
Bigfoot Biomedical announced today that it received FDA 510(k) clearance for its Bigfoot Unity diabetes management system.Milpitas, Calif.-based Bigfoot’s first-of-its-kind Bigfoot Unity system features connected...