Regulatory Approvals

Amber Implants received FDA 510(k) clearance for its VCFix Spinal System. The Netherlands-based company designed VCFix to treat vertebral compression fractures. The system is a...

Novocuff, Inc., a clinical-stage, maternal health medical device company, today announced approval from the U.S. Food and Drug Administration of its Investigational Device Exemption...

Womed Leaf Resorbable Adhesion Barrier receives PMA approval for women suffering from moderate to severe intrauterine adhesions, a major cause for female infertility. Womed, the...

Novocure received regulatory approval in Japan for its Optune Lua wearable device. Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Optune Lua for concurrent...

Avita Medical, a leading therapeutic acute wound care company, today announced it has received the CE Mark under the European Union Medical Device Regulation...

B. Braun acquired True Digital Surgery (TDS), a company specialising in digital robotic-assisted 3D surgical microscopy. The company said its acquisition highlights its commitment to...

Pulnovo Medical announced it received two FDA investigational device exemption (IDE) approvals for its technology. Shanghai-based Pulnovo won IDEs for its pulmonary artery denervation (PADN)...

Centinel Spine, the leading global medical device company focused exclusively on treating cervical and lumbar spinal disease with the most complete and clinically-proven total...

UK-based Naitive Technologies has gained 510(k) clearance from the US Food and Drug Administration (FDA) for OsteoSight, an artificial intelligence (AI)-powered software for bone...