Article Name Regulatory
UroMems Secures FDA and ANSM Clearance to Begin Pivotal Study of UroActive® Smart Implant for Male SUI
Landmark trial to evaluate world’s first autonomous, electronic artificial urinary sphincter for stress urinary incontinence in men
18th July, 2025
Medtronic Secures CE Mark for LigaSure™ Integration on Hugo™ Robotic System, Advancing the Future of Surgery
The regulatory milestone enables the use of Medtronic’s trusted vessel sealing technology on its Hugo™ robotic-assisted surgery platform, enhancing precision and expanding clinical versatility across Europe.
16th July, 2025
HistoSonics Secures Expanded Insurance Coverage for Liver Tumor Therapy
Non-Invasive Histotripsy Treatment Now Accessible to 7 Million Blue Cross Blue Shield Highmark Members Across U.S.
15th July, 2025
Zimmer Biomet to Acquire Monogram Technologies in Strategic Move to Enhance Robotic Surgery Portfolio
Definitive agreement strengthens Zimmer Biomet’s position in orthopedic innovation by integrating autonomous robotic technology into its surgical solutions suite.
14th July, 2025
Medtronic Responds to CMS Proposed National Coverage Determination for Symplicity Spyral™ RDN System
Company Welcomes Milestone Toward Expanding Medicare Access to Innovative Renal Denervation Therapy for Uncontrolled Hypertension
14th July, 2025
AirLife and Vyaire Recall Infant Ventilation Circuits Over Life-Threatening Disconnection Risk
FDA issues Class I recall for AirLife Infant Heated Wire Circuits following reports of adapter disconnections that could lead to hypoxia or respiratory failure in neonatal patients.
14th July, 2025
FDA Lists 200+ Sensor-Based Digital Health Devices Cleared Between 2014–2025, Redefining Remote Patient Monitoring
From smartwatches to continuous glucose monitors, the growing FDA list highlights how wearable sDHTs are transforming healthcare beyond the clinic into homes and everyday life
14th July, 2025
FDA Lists 90+ AR/VR Medical Devices Approved Between 2015–2025, Cementing a Decade of Immersive Tech in Clinical Care
With dozens of approved devices across neurology, orthopaedics, and radiology, the FDA underscores its commitment to guiding safe, innovative integration of augmented and virtual reality in healthcare
14th July, 2025
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
Medtech Special
© 2023 MM Activ Sci-Tech Communications. All rights reserved | Disclaimer