Regulatory Approvals

 Vesalio announces CE Approval for new NeVa NET™, the first integrated clot micro-filtration technology for stroke thrombectomy patients   NeVa Net™ micro-filtration technology coupled with NeVa’s...

The D-Tect MT accessory recognises movement in three hand areas and does not require cords or sensors. Neuronetics has received 510(k) clearance from the US Food and...

Omnipod 5 is the first tubeless AID System cleared in the U.S. for preschool children Insulet Corporation, the global leader in tubeless insulin pump technology with its...

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...