MedTech Spectrum

Article Name Regulatory

Newronika’s AlphaDBS Secures CE Mark for Adaptive Deep Brain Stimulation System

Next-generation closed-loop DBS device now approved in Europe, offering real-time, personalized neuromodulation for Parkinson’s and other neurological disorders.

25th March, 2025

Okami Medical Secures FDA 510(k) Clearance for SENDERO MAX Delivery Catheter

Expanded SENDERO portfolio now supports LOBO occluders across 1.5mm to 9.0mm vessels, offering physicians a comprehensive embolization solution for rapid and reliable vessel closure.

25th March, 2025

Anuncia Wins FDA Breakthrough Status for ReFlow® EVD

With its expanded ReFlow® portfolio, Anuncia targets improved ICU outcomes, reduced surgical interventions, and greater global access to CSF management—from U.S. hospitals to underserved regions in Africa.

24th March, 2025

Subtle Medical’s AI-Powered SubtleHD™ Secures CE Mark, Bringing Faster, Higher-Quality MRI Imaging to Europe

Innovative software enhances MRI scan quality, reduces scan times by up to 80%, and optimizes radiology workflows without requiring hardware upgrades.

17th March, 2025

Boulder iQ Executives to Share Fast-Track Strategies for MedTech Innovation at LSI USA 25

Industry leaders Jim Kasic and Larry Blankenship to present time- and cost-efficient approaches for accelerating medical device development and market entry.

17th March, 2025

Spinal Resources Inc. Secures Patent for Bezier Parametric Curve Spinal Rod System

Innovative Spinal Rod Technology Enhances Surgical Flexibility and Patient-Specific Customization

14th March, 2025

Baird Medical Gains Indonesian Regulatory Approval for Microwave Ablation Technology

Approval paves the way for broader adoption of Baird Medical’s minimally invasive treatment for tumor ablation, expanding access to advanced cancer care in Indonesia.

11th March, 2025

Beckman Coulter Secures FDA Clearance for DxC 500i Clinical Analyzer

The integrated clinical chemistry and immunoassay system enhances efficiency, streamlines lab workflows, and delivers accurate diagnostics in a compact design.

11th March, 2025

SkinCure Oncology Submits GentleBeam™ for FDA Clearance, Expanding Noninvasive Skin Cancer Treatment

GentleBeam™ aims to enhance Image-Guided SRT for nonmelanoma skin cancer, reinforcing SkinCure Oncology’s commitment to patient-centered, nonsurgical care.

10th March, 2025

Zimmer Biomet Wins FDA Nod for Metal-Safe Knee Implant

Zimmer Biomet Secures FDA Clearance for Persona® Revision SoluTion™ Femur, Expanding Options for Metal-Sensitive Knee Implant Patients

10th March, 2025

Optellum and Volpara Health Partner to Enhance AI-Driven Cancer Risk Assessment

Strategic agreement integrates Optellum’s AI-powered lung nodule analysis with Volpara’s early cancer detection tools, enabling a more comprehensive approach to patient risk evaluation.

05th March, 2025

NAMSA acquires WuXi AppTec’s US medical device testing operations to expand expertise and capacity

The acquisition strengthens NAMSA’s leadership in medical device biological safety testing, adding expertise, lab capacity, and scientific resources to support global manufacturers.

04th March, 2025

South Korea’s DeepQure Advances Global Clinical Trials for Innovative RDN Technology

Pioneering Extravascular Renal Denervation for Resistant Hypertension

04th March, 2025

Sebelas Miudella™ Becomes First FDA-Approved Hormone-Free IUD in 40 Years

Offering a long-acting, non-hormonal birth control option, the approval marks a significant milestone in expanding contraceptive choices for individuals seeking hormone-free alternatives.

03rd March, 2025

1 in 3 at Risk: Cardiologists Urge Global Action on Pulse Day to Tackle Silent Epidemic of Heart Rhyhm Disorders

With cases of atrial fibrillation and other heart rhythm disorders rising rapidly, the European Heart Rhythm Association (EHRA) calls for greater awareness and early detection—starting with a simple pulse check on 1 March.

03rd March, 2025

Arcuro Medical Secures FDA 510(k) Clearance for SuperBall-RC™ Rotator Cuff Repair System

New device simplifies graft fixation, enhancing rotator cuff repair outcomes with a planned launch in 2025.

28th 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