MedTech Spectrum

Article Name Regulatory

ZYLOX Wins Indonesian Approval for Unicorn™ Vascular Closure Device

Regulatory clearance marks strategic expansion of ZYLOX’s innovative vascular technology in Southeast Asia.

27th May, 2025

Koning Health Partners with Sage Tap Poder to Advance Global Adoption of Koning Breast CT

New investment to accelerate global rollout of Koning’s 3D breast imaging technology.

23rd May, 2025

Median Technologies Unveils eyonis® LCS at Major North American Health Conferences

Groundbreaking Imaging Technology for Cancer Detection to Be Presented in May 2025

13th May, 2025

VUNO’s AI Cardiac Risk System Gains CE MDR and UKCA Certifications

Milestone Approvals Enable European and UK Market Access for AI-Based Cardiac Arrest Prediction Tool

12th May, 2025

Teal Health’s Teal Wand™ Receives FDA Approval as First At-Home Cervical Cancer Screening Device

Breakthrough self-collection technology offers women a more comfortable, accessible alternative to traditional in-clinic screenings, aiming to boost early detection and public health outcomes.

12th May, 2025

InMode Secures Injunction to Halt Counterfeit Morpheus8 Sales

Court Blocks Unauthorized Distribution of InMode’s RF Microneedling Devices and Cartridges in Major IP Protection Win

07th May, 2025

Turbett Surgical Secures FDA 510(k) Clearance for Enhanced Instrument Pod Portfolio

New TS1200 model supports up to 300 lbs, offering hospitals a more efficient, scalable solution for surgical instrument transport and storage.

14th April, 2025

Siemens Healthineers’ Antithrombin Blood Test Gains FDA Clearance as Qfitlia Companion Diagnostic

New Approval Supports Precision Treatment for Hemophilia Patients

31st March, 2025

Visby Medical Gains FDA De Novo Authorization for First OTC PCR Sexual Health Test

Groundbreaking Approval Expands Access to Rapid, At-Home STI Diagnostics

31st March, 2025

Abbott’s Volt™ PFA System Gains CE Mark for Treating Abnormal Heart Rhythms

Innovative Pulsed Field Ablation Technology Advances Cardiac Care in Europe

28th March, 2025

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