Regulatory Approvals

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 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...

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 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...

RenovaCare, Inc., announced that its Investigational Device Exemption (IDE) application has been granted full approval by the U.S. Food and Drug Administration (FDA). This...

HANNOVER, Germany and SAN DIEGO, CA, April 28, 2021 / B3C newswire / -- Implandata Ophthalmic Products, a digital health company with offices in Germany...

Pixee Medical received FDA 510(k) clearance to market its Knee+ AR computer assisted orthopedic solution. Knee+ is designed to help orthopedic surgeons perform surgeries better...

IpsiHand exoskeleton uniquely leverages brain-computer interface technology for chronic stroke rehabilitation IpsiHand also has been granted U.S. FDA Breakthrough Device Designation Neurolutions, Inc., a medical device company...

EDGe Surgical, Inc., a company focused on developing and manufacturing smart orthopedic and spine surgical instruments, announced today that its next-generation Awl-in-One Tap™ device...