Regulatory Approvals

Alabama-based technology company Curiteva announces the first FDA 510(k) cleared 3D-printed PEEK implant, the Inspire Porous PEEK Cervical Interbody System with HAFUSE Technology. The Inspire platform is...

Belgium-based scale-up, Sunrise, announced the U.S. Food and Drug Administration (FDA) has cleared for use its second generation at-home sleep apnea test that uses artificial...

The IDE approval will enable data on the safety and efficacy of the Magic Touch PTA Sirolimus Coated Balloon to be collected. The US Food...

AI-powered image analysis tool expedites oral health analysis and measures radiographic signs of periodontal disease VideaHealth, the trusted dental artificial intelligence (AI) platform, announced the...

Catalyst is first-to-market with a fully convertible system that features an ellipsoid anatomic head Catalyst OrthoScience Inc. (Catalyst), a medical device company focused on the upper...

Stratasys (NASDAQ: SSYS) introduced its TrueDent resin for making 3D-printed dentures. TrueDent is the first FDA-cleared medical device for the company, which is based in Eden Prairie,...

Boston Scientific Corporation announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System, the first ureteroscope...

SPR Therapeutics, a private medical device company focused on treating pain and improving the quality of life for patients managing acute or chronic pain,...

Avingtrans medical imaging technology associate firm Adaptix has received US Food and Drug Administration (FDA) 510(k) clearance for its orthopaedic medical imaging product. The Digital Tomosynthesis Orthopaedic imaging system, which...