Regulatory

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...

Medtech Industry Prioritizes Postmarket Quality Overhaul

88% of Companies Set Modernization Plans in Motion Within Three Years ...

JBA AI Secures FDA Recognition for Software as a Medical Device (SaMD)

Regulatory Milestone Validates JBA AI’s Clinical-Grade Software for Advanced Diagnostic Support...

ZYLOX Wins Indonesian Approval for Unicorn™ Vascular Closure Device

Regulatory clearance marks strategic expansion of ZYLOX’s innovative vascular technology in Southeast Asia....

Koning Health Partners with Sage Tap Poder to Advance Global Adoption of Koning Breast CT

New investment to accelerate global rollout of Koning’s 3D breast imaging technology....

Median Technologies Unveils eyonis® LCS at Major North American Health Conferences

Groundbreaking Imaging Technology for Cancer Detection to Be Presented in May 2025...