Regulatory Approvals

Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a...

The Varisync plate is indicated for anterior screw fixation to the cervical spine of patients with deformity. Zavation Medical Products has obtained 510k clearance from the US Food...

MedWand™ Solutions Receives FDA 510(k) Clearance MedWand Solutions, Inc. is pleased to announce that the company's groundbreaking MedWand device and VirtualCare ecosystem is commercially available to...

VySpine this week announced it received FDA 510(k) clearance for its VyPlate anterior cervical plate system. Tallahassee, Florida-based VySpine designed VyPlate to stabilize the anterior cervical...

The Visibly Digital Acuity Product uses a touchscreen mobile device paired with a computer to test how sharp a user's vision is at a...

SyncThink, a neurotechnology company, and makers of the EYE-SYNC technology, has completed CE Mark certification, affirming conformity to European Medical Device Regulation (MDR). EYE-SYNC...

The Bodyport Cardiac Scale allows individuals with fluid management conditions to monitor heart function and fluid status. Digital therapeutics firm Bodyport has received 510(k) clearance from the...

Not so long ago in our very own galaxy, the FDA saw fit to expand its list of authorized robotic surgery systems—no epic interplanetary...

Endologix Receives CE Mark Certification under EU-MDR for AFX®2 Endovascular AAA System Endologix LLC, a privately held global medical device company dedicated to improving patients’...