Regulatory Approvals

FDA outlines best practices for healthcare AI, alongside Canada, U.K. regulators

The FDA is joining hands with fellow regulators in Canada and the U.K. to present 10 principles outlining best practices in the development of...

Cheek swab COVID-19 test receives CE mark

Intelligent Fingerprinting’s saliva-based COVID-19 test now carries CE marking. The new VSS-GP COVID-19 Saliva Test uses a swab to collect saliva from just inside the cheek, providing...

Trice Medical nabs first FDA go-ahead for disposable arthroscope with 25-degree view

Though disposable needle arthroscopes have become increasingly popular due to their lower risk of contamination and less invasive profile, full-size reusable arthroscopes are still the...

AI-powered ‘Test-To-Go’ system receives CE mark

Clinical AI company Sensyne Health’s licence and development partner, Excalibur Healthcare Services, has received European regulatory certification, which includes the UK, for its ‘Test-To-Go’ COVID-19...

Luminopia scores FDA De Novo for VR treatment for lazy eye

The tool uses virtual reality to modify media content in order to help children boost their visual acuity. Massachusetts-based Luminopia landed an FDA De Novo...

Kerecis Announces First-Ever Fish-Skin Implantable Medical Product for Surgery

Fish graft used in human plastic and reconstructive surgery to reinforce soft tissue Kerecis®, the company pioneering the use of fish skin and fatty acids...

HistoSonics Receives FDA “Breakthrough Device Designation” for Novel Sonic Beam Therapy

HistoSonics, (www.histosonics.com), the developer and manufacturer of a non-invasive platform and novel sonic beam therapy called histotripsy, announced today that the U.S. Food and...

Q’Apel Medical Secures U.S. Patent for its SelectFlex™ Technology

Q’Apel Medical, Inc. has announced that the United States Patent & Trademark Office has granted the company U.S. Patent No. 11,123,522 covering important features of...

Life Spine Announces FDA 510(k) Clearance for the ProLift® Micro Expandable Spacer System

Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it...
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