Regulatory
MiRus Receives FDA Clearance for MoRe® Low-Profile Spinal Plating Systems
MiRus® announced that it has received FDA 510(k) clearance of the CYGNUS™ MoRe® Anterior Cervical Plate and MiRus® 3DR™ Lateral Lumbar Interbody Fusion System with Integrated MoRe® plate fixation, both being the narro...Read more
19th October, 2023
GE Healthcare Gets FDA Clearance for Allia IGS Pulse: Next-Gen Cardiac Imaging System
GE HealthCare (Nasdaq: GEHC) announced US FDA 510(k) clearance of Allia IGS Pulse - the latest addition to the company’s image guided system (IGS) offerings. Allia IGS Pulse features a new imaging chain engineered to pro...Read more
17th October, 2023
Werfen Secures FDA 510(K) Clearance for Aptiva® Tissue Disease Reagent
New Reagent Aids in Diagnosis of Connective Tissue Disease in Hard-to-Diagnose Autoimmune Diseases, Reducing Time to Diagnosis and Improving Patient Outcomes ...Read more
17th October, 2023
Boston Scientific Gets FDA Nod for Spinal Cord Stimulation in Diabetic Neuropathy
Nearly 50% of American adults living with diabetes will be affected by diabetic neuropathy complications in their lifetime...Read more
14th October, 2023
Roche's Fenebrutinib Shows Brain Penetration and Lesion Reduction in Multiple Sclerosis Patients: Late-breaking Data
Roche announced new data from the Phase II FENopta study showing that investigational, oral fenebrutinib is brain penetrant and reduces brain lesions in people with relapsing multiple sclerosis (RMS) with a consistent s...Read more
14th October, 2023
Neoss® Group receives EU Medical Device Regulation (MDR) certifications for implants and abutments
Neoss Group, a leading innovator in dental implant solutions, is proud to announce that it has received EU Medical Device Regulation (MDR) certification by its Notified Body, the BSI Group, the Netherlands B.V. for its i...Read more
13th October, 2023
Indian Medtech Startup Sigtuple Earns First FDA Approval in India's Space
SigTuple’s AI100 with ShonitTM receives U.S. FDA 510(k) Clearance...Read more
03rd October, 2023
4WEB Medical Receives 510k Clearance to Market New Integrated Cervical Plate
Company Continues to Build Momentum with Most Recent Portfolio Expansion....Read more
28th September, 2023
Saluda Medical Receives FDA Approval for Evoke® System MRI Labeling
Patients implanted with the Evoke® System now eligible for full-body MRI scans...Read more
27th September, 2023
Qure.ai receives 510(k) FDA clearance for chest X-ray solution for Pneumothorax and Pleural Effusion
A monumental step towards getting healthcare AI to augment critical care and emergency care...Read more
18th September, 2023
Medtech Special
- Lunit AI Boosts Cancer Detection in Largest Single-Reading Mammography Study
- Baird Medical Gains Indonesian Regulatory Approval for Microwave Ablation Technology
- Medtronic’s SMART Trial Confirms Evolut™ TAVR’s Superior Valve Performance at Two Years
- Zimmer Biomet Wins FDA Nod for Metal-Safe Knee Implant
- SkinCure Oncology Submits GentleBeam™ for FDA Clearance, Expanding Noninvasive Skin Cancer Treatment
- Stryker’s Inari Medical Introduces Artix Thrombectomy System to Enhance Arterial Clot Removal
- Closing the Gap: Advancing Women’s Health Through Equity and Innovation
Artificial Intelligence Breakthroughs
- MoveUP Acquires Deep Structure AI to Elevate AI-Powered Orthopedic Care
- CLEW Launches AI-Powered Sepsis Virtual Unit to Strengthen SEP-1 Compliance
- Lunit AI Boosts Cancer Detection in Largest Single-Reading Mammography Study
- Zimmer Biomet Wins FDA Nod for Metal-Safe Knee Implant
- OSE Immunotherapeutics and Scienta Lab partner to advance AI-driven Precision Immunotherapy
- Optellum and Volpara Health Partner to Enhance AI-Driven Cancer Risk Assessment
- Synergy Laboratories Introduces AI-Powered Genius™ Digital Diagnostics System for Advanced Cervical Cancer Screening
Robots In Medtech
- Australia's University of Queensland Unveils shape-shifting Liquid Metal Robotics
- India's SS Innovations makes history with first robotic cardiac surgery in Indonesia
- Momentis Surgical Secures FDA Clearance for Advanced Anovo® Robotic Platform, Setting New Standards in Single-Incision Surgery
- Momentis Surgical expands to general surgery market with FDA 510(k) clearance for its Anovo Robotic system
- Intuitive and India-based KIMS Hospitals sign MoU to launch 25 new robotic surgery programmes
- ZEISS introduces its latest Robotic Visualisation System for neuro surgery
- Surgical robotics pioneer Intuitive opens Global Capability Centre in Bengaluru, India
Asia Pacific
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