Regulatory

Boston Scientific Secures FDA Approval for Expanded Labeling of FARAPULSE™ PFA System

Milestone enhances clinical use of the FARAPULSE™ Pulsed Field Ablation platform for treatment of atrial fibrillation, strengthening its role in next-generation cardiac electrophysiology....

Morphic Medical Secures CE Mark for RESET® Endoscopic Therapy Device

Regulatory milestone paves the way for expanded access to Morphic’s non-implant, incisionless solution for treating acid reflux and related gastrointestinal disorders across Europe....

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....