Wednesday, 24 September 2025

Regulatory

ReCerf Receives CE Mark, Expanding Access to Advanced Hip Resurfacing in Europe

Ceramic-based hip resurfacing implant gains European regulatory approval, offering patients a bone-preserving, metal-free alternative for hip joint restoration....

BCC Research Publishes 2024 Review of Global Medical Devices Market

Comprehensive Report Highlights Emerging Trends, Market Drivers, and Forecasts Shaping the Future of the Medical Devices Industry....

Philips Secures FDA Clearance for SmartSpeed Precise, Advancing MRI Speed and Image Precision

Dual AI-Powered Imaging Software Set to Enhance Diagnostic Confidence and Workflow Efficiency in MRI...

Median Technologies Advances AI-Powered Lung Cancer Screening with CE Mark Filing for eyonis® LCS

Regulatory submission for Class IIb CE Mark and ISO 13485 certification paves the way for European launch of Median’s AI-driven SaMD platform targeting early lung cancer detection....

ANA5 Funnel Catheter by ANACONDA Biomed Gets CE Mark, Unlocking New Era in Stroke Thrombectomy

CE Mark Approval Advances Precision Thrombectomy with Vessel-Conforming Design for Improved Stroke Outcomes Across Europe...

PathAI Secures FDA Clearance for AISight® Dx Diagnostic Platform

Regulatory Approval Enables AISight® Dx Use in Primary Diagnosis, Advancing AI-Powered Pathology Solutions...

Cook Recalls Beacon Tip Angiographic Catheters Over Tip Separation Risk Flagged as Class I by FDA

Tip separation during angiographic procedures may lead to life-threatening complications including embolism, sepsis, and cardiac arrhythmia; three serious injuries reported, prompting urgent recall. ...

Medtronic’s Bravo Device Under Fire: FDA Flags High-Risk Flaw After 33 Safety Incidents Reported

Misapplied adhesive in Bravo CF capsule delivery systems linked to 33 serious injuries; Medtronic initiates urgent recall as FDA warns of high-risk complications including aspiration, perforation, and delayed diagnosis....

42 Olympus Medical Devices Face FDA Import Alert Over Quality Violations

Following multiple unresolved warnings, the U.S. FDA enforces import restrictions on 42 Olympus endoscopic devices, spotlighting persistent quality system lapses at its Aizu facility in Japan and triggering global scrutiny of manufacturing and patient safety standards. ...

ANACONDA Biomed Earns CE Mark for ANA5 Funnel Catheter

Next-Gen Stroke Device Aims to Enhance Clot Removal and Improve Outcomes in Ischemic Stroke Treatment Across Europe...