MedTech Spectrum

Article Name 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.

27th February, 2025

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.

26th February, 2025

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.

26th February, 2025

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.

26th February, 2025

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).

26th February, 2025

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

25th February, 2025

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.

25th February, 2025

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.

25th February, 2025

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.

24th February, 2025

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.

21st February, 2025

South Korea’s PranaQ Secures FDA Clearance for AI-Powered Sleep Apnea Wearable, Backed by NAVER D2SF

With FDA 510(k) clearance for TipTraQ, PranaQ is set to transform home-based sleep diagnostics. The AI-driven wearable, supported by NAVER D2SF, delivers clinical-grade sleep and respiratory insights, ensuring accessible, multi-night testing and seamless remote monitoring. With FDA 510(k) clearance for TipTraQ, PranaQ is set to transform home-based sleep diagnostics. The AI-driven wearable, supported by NAVER D2SF, delivers clinical-grade sleep and respiratory insights, ensuring accessible, multi-night testing and seamless remote monitoring.

21st February, 2025

Medcrypt Enhances Helm to Help Medical Device Manufacturers Streamline Cybersecurity Compliance

With advanced SBOM management, automated vulnerability tracking, and FDA-ready reports, Helm reduces risk, lowers costs, and accelerates regulatory approval for medical device manufacturers.

20th February, 2025

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

With CE Mark certification, the AI-powered ECGenius System is now approved for commercialization in the European Economic Area, enhancing real-time electrogram recording and clinical decision-making for healthcare providers.

20th February, 2025

Philatron Wire & Cable Unveils FlexyCord™ – The Ultimate Retractile Cord for Medical & Healthcare Applications

Engineered for precision, durability, and space efficiency, the patented FlexyCord™ coiled cable delivers unmatched reliability in critical medical environments.

18th February, 2025

QuantalX Secures CE MDR Approval for Delphi-MD, Paving the Way for EU Commercialization

Breakthrough Neurodiagnostic Device Aims to Transform Early Detection and Treatment of Neurological Disorders Across Europe

18th February, 2025

NX Taiwan Secures TFDA Certification for Medical Device Quality Management—A First for a Japanese Company

Nippon Express (Taiwan) Co., Ltd. earns medical device QMS certification for its NEXT3 warehouse in Taoyuan, reinforcing its capabilities in compliant storage, packaging, and labeling of medical devices to meet Taiwan’s stringent quality control standards.

17th February, 2025

Sanofi’s Merilog Wins FDA Approval as First Rapid-Acting Insulin Biosimilar for Diabetes

The U.S. FDA has approved Merilog (insulin-aspart-szjj), Sanofi’s biosimilar to Novolog, marking a significant step toward expanding access to affordable insulin. The approval strengthens competition in the diabetes treatment market, offering a new rapid-acting insulin option for millions of patients.

17th February, 2025

Navi Medical Secures FDA Clearance for Neonav® Pediatric Vascular Access System

The first-of-its-kind system, designed specifically for neonatal and pediatric patients, leverages real-time ECG signal analysis to improve CVAD placement, enhance patient safety, and reduce complications, marking a major milestone in global pediatric healthcare.

17th February, 2025