Article Name Regulatory
The 2025 Index: 100 FDA-Approved AI-Driven Medical Devices
Spanning Radiology, Cardiology, Neurology, and More, the List Highlights FDA’s Ongoing Commitment to Advancing Safe and Effective AI Integration in Healthcare
14th July, 2025
SimBioSys Earns Third FDA Clearance for TumorSight™ Viz
AI-Powered 3D Surgical Planning Tool Advances Precision Breast Cancer Surgery with Latest Regulatory Milestone
10th July, 2025
U.S. FDA Grants Breakthrough Device Designation to Artera’s AI-Powered Prostate Cancer Decision Support Tool
Innovative software platform leverages artificial intelligence to personalize therapy decisions and improve clinical outcomes for prostate cancer patients.
10th July, 2025
MediView Launches Multicenter Study to Validate XR90™ Extended Reality Surgical Navigation
Study to Evaluate Accuracy and Clinical Impact of XR-Guided Soft Tissue Biopsy Across Leading U.S. Medical Centers
09th July, 2025
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.
08th July, 2025
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.
08th July, 2025
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.
04th July, 2025
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.
04th July, 2025
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
03rd July, 2025
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.
03rd July, 2025
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
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