Regulatory Approvals

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Tempus AI’s ECG-Low (ejection fraction) EF software. This software utilises AI to detect...

Synchrony Medical received FDA 510(k) clearance for its LibAirty airway clearance system. LibAirty addresses a need for patients with chronic lung diseases such as chronic...

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Exactech’s Equinoxe scapula reconstruction system for treating acromial and scapular spine fractures. These...

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...