The US Food and Drug Administration (FDA) has granted approval for Valcare Medical’s investigational device exemption application, allowing it to begin an early feasibility...
The US Food and Drug Administration (FDA) has granted clearance to Caristo Diagnostics for CaRi-Plaque, an AI-assisted software application that diagnoses coronary artery disease...
The US Food and Drug Administration (FDA) has cleared Miach Orthopaedics Bridge-Enhanced ACL Restoration (BEAR) implant for expanded use in treating complete and partial...
Ronovo Surgical has received regulatory approval for its Carina surgical robotic platform in China. Shanghai-based Ronovo develops broad, cross-specialty robotic-assisted surgery (RAS) technology. It...
Cerus Corporation has obtained CE mark approval for its INT200, a light-emitting diode (LED)-based illumination device, for the Intercept Blood System for platelets and...
Phantom Neuro today announced it received FDA breakthrough device designation and Targeted Acceleration Pathway (TAP) designation for its minimally invasive neural interface Phantom X.
The...
Penderia Technologies, a company developing wireless sensor technologies for orthopedic applications and in collaboration with MRC Global, LLC, recently received the FDA’s Breakthrough Device...
ABANZA, a leader in advanced soft tissue repair solutions, shared the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its innovative...