Regulatory Approvals

The FDA has granted 510(k) clearance to the TaviPilot AI software developed by Caranx Medical, according to company officials. Pierre Berthet-Rayne, the company’s co-founder and...

AIRS Medical, a leader in AI solutions for diagnostic imaging, has received Medical Device Regulation (MDR) certification from the European Union (EU) for SwiftMR...

Mendaera has received FDA 510(k) clearance for its Focalist handheld robotic system, which enhances the precision of ultrasound-guided needle placement across multiple specialties. The San...

MatOrtho’s ReCerf hip resurfacing arthroplasty (HRA) has secured the CE mark, signifying its adherence to European safety and performance standards. The certification enables broader access...

Fasikl has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Felix NeuroAI Wristband, designed to address tremor-related functional limitations...

Methinks AI announced its non-contrast computed tomography (NCCT) Stroke software has received 510(k) clearance from the US Food and Drug Administration (FDA). A press...

Intuitive Surgical received CE mark for its da Vinci 5 surgical robotic system. The surgical robotics leader earned approval for adult and pediatric use in Europe....

Neurent Medical announced Cigna Healthcare intends to provide coverage for its Neuromark system for chronic rhinitis. Cigna will provide coverage for Neuromark for treating the...

Glaukos announced it received EU MDR certification for its iStent Infinite, along with several other technologies. Aliso Viejo, California-based Glaukos can now bring iStent Infinite...