Regulatory Approvals

icotec gets FDA clearance for extended VADER Pedicle System

The approval granted for the system includes Ø 4.5mm pedicle screws and extended long Carbon/PEEK rods. Swiss medical device manufacturer icotec ag has received 510(k)...

Infinity Neuro Receives CE Mark Approval for Their First Device to Treat Stroke

Infinity Neuro announced that its Inspira™ aspiration catheters received CE Mark approval and are now commercially available in Europe. This is the first offering from...

Realize Medical wins FDA clearance for VR-based surgical planning software

Realize Medical announced that it received FDA 510(k) clearance for its Elucis virtual reality (VR) software for surgical planning. The Ottawa, Canada-based startup designed Elucis...

Proclaim XR Spinal Cord Stimulation Wins Approval for Painful Diabetic Peripheral Neuropathy

The Abbott system previously earned approval for chronic pain in 2019, and adds another option for a patient population with no disease-modifying agents available...

Varian Receives Investigational Device Exemption for RADIATE-VT™ Clinical Trial

Varian, a Siemens Healthineers company, has announced that the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) for the pivotal...

PENTAX Medical obtains CE marks for video processor and endoscope series

PENTAX Medical INSPIRA combines the latest functionalities in one solution, which can be controlled with a touch panel. HOYA Group division PENTAX Medical has received CE marks for...

Abbott wins FDA nod for its Navitor transcatheter aortic valve implant

Abbott (NYSE:ABT) announced that it received FDA approval for its latest-generation transcatheter aortic valve implantation (TAVI) system. The company designed the Navitor system for treating people...

EndoTheia Inc. Announces FDA Breakthrough Device Designation for Technology to Improve Endoscopic Surgery

EndoTheia Inc. Announces FDA Breakthrough Device Designation for Technology to Improve Endoscopic Surgery EndoTheia’s Breakthrough Device leverages foundational technology that was originally invented at Vanderbilt and...

Opticyte Earns FDA Breakthrough Device Designation for the First Cell O2 Patient Monitor for Organ Failure

 Opticyte, a medical device start-up, announced that its Cell O2 Patient Monitor received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA)...
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