Medical Devices

China Approves ZEISS VISUMAX® 800 with SMILE® Pro, Elevating Laser Vision Correction Standards

The next-generation femtosecond laser enhances surgical precision, reduces treatment time, and integrates AI-driven features, reinforcing ZEISS’ leadership in refractive surgery innovation....

OrthoNovis Secures FDA Clearance for BPS Wrist Fracture System

The 510(k) clearance enables OrthoNovis to enter the U.S. orthopedic fracture fixation market with its innovative locking wrist plates, advancing treatment options for distal radius fractures and fusions. ...

Averto Medical’s ColoSeal™ Wins FDA Breakthrough Device Designation for Colorectal Surgery

Minimally invasive ICD system aims to eliminate temporary ostomies, improving recovery and quality of life for patients undergoing colorectal surgery....

Allwin Medical Devices and Esco Forge Strategic Partnership to Strengthen IVF Solutions and Expand Global Reach

The collaboration enhances Esco's IVF instrument portfolio with Allwin's consumables, offering a comprehensive solution for IVF clinicians and embryologists while expanding market presence in India....

Olympus APAC Expands Availability of iTind™ for BPH Treatment Across Asia-Pacific

With an upcoming launch in Korea, Olympus strengthens access to its minimally invasive iTind procedure, enhancing patient care and easing hospital capacity pressures for men with benign prostatic hyperplasia (BPH)....

Medtronic Secures FDA Approval for BrainSense™ Adaptive DBS, Pioneering Largest BCI-Enabled Therapy Launch

New real-time, self-adjusting deep brain stimulation system transforms Parkinson’s care with personalized neuromodulation...

CathVision Secures CE Mark for ECGenius System, Expanding Electrophysiology Solutions Across Europe

With CE Mark approval, CathVision’s AI-powered ECGenius System is set to launch in the European market, enhancing real-time electrogram recording and clinical decision-making for healthcare providers....

IceCure Medical Seeks Israeli Regulatory Approval for Next-Gen XSense™ Cryoablation System

Building on FDA clearance, IceCure files for Israeli approval of its XSense™ System, expanding minimally invasive cryoablation solutions across multiple medical specialties in line with the growing trend of surgical de-escalation. ...

Co-Diagnostics Withdraws 510(k) Submission for COVID-19 Test to Pursue Enhanced Version

Following constructive discussions with the FDA, Co-Dx shifts focus to an improved test submission, incorporating platform advancements and optimizing long-term performance....

SurgiBox Secures Two U.S. Patents to Advance Mobile Surgery Innovation

Cambridge-based medical device startup SurgiBox Inc. receives utility and design patents for its SurgiField™ technology, enhancing mobile surgical capabilities with advanced airflow and smart control innovations....