Regulatory Approvals

Hyalex Orthopaedics’ supplemental investigational device exemption (IDE) application has received approval from the US Food and Drug Administration (FDA) for a clinical trial of...

Atia Vision received FDA investigational device exemption (IDE) approval to study its OmniVu lens system. The Shifamed portfolio company can now begin a traditional feasibility...

Gradient Denervation Technologies announced its pulmonary denervation system has received Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This program creates...

Ophthalmic technology developer Intalight has received the CE mark for its DREAM OCT platform, allowing the company to commercialise it within the European...

Trax Surgical received FDA 510(k) clearance to market its Linkt Compression Staple System. According to the Stoughton, Massachusetts-based orthopedic product development and distribution company, the...

Elucent Medical, a leading innovator in the field of guided surgical technologies, announced today that the U.S. Food and Drug Administration (FDA) has granted...

RebrAIn, a pioneering France based medtech company, with commercial operations in Europe and the United States, announced the achievement of its CE certification under...

South Korean company VUNO’s Med-DeepCARS (DeepCARS) solution has secured CE MDR certification in the European Union (EU), along with the UK Conformity Assessed (UKCA)...

The US Food and Drug Administration (FDA) has secured approval to Teal Health’s at-home vaginal sample self-collection device, Teal Wand, for cervical cancer screening. This...