MedTech Spectrum

Article Name Regulatory

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

02nd July, 2025

PathAI Secures FDA Clearance for AISight® Dx Diagnostic Platform

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

01st July, 2025

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.

26th June, 2025

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.

25th June, 2025

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.

25th June, 2025

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

19th June, 2025

Medtech Industry Prioritizes Postmarket Quality Overhaul

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

09th June, 2025

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

09th June, 2025

ZYLOX Wins Indonesian Approval for Unicorn™ Vascular Closure Device

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

27th May, 2025

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.

23rd May, 2025

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

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

13th May, 2025

VUNO’s AI Cardiac Risk System Gains CE MDR and UKCA Certifications

Milestone Approvals Enable European and UK Market Access for AI-Based Cardiac Arrest Prediction Tool

12th May, 2025

Teal Health’s Teal Wand™ Receives FDA Approval as First At-Home Cervical Cancer Screening Device

Breakthrough self-collection technology offers women a more comfortable, accessible alternative to traditional in-clinic screenings, aiming to boost early detection and public health outcomes.

12th May, 2025