Article Name Regulatory

JINGHAO MEDICAL's self-fitting OTC hearing aids received FDA 510(k) approval

As the first hearing aid manufacturer to be listed in China, JINGHAO MEDICAL has once again taken a historic step. On September 26, 2023, the self-fitting OTC hearing aid developed and manufactured by JINGHAO MEDICAL off...Read more

24th October, 2023


Medtronic FDA Approved for Extravascular Defibrillator for Heart Rhythms

First-of-its-kind Aurora EV-ICD™ system offers single device, single procedure with lead placed outside of heart and veins...Read more

24th October, 2023


DeepTek.ai secures US FDA clearance for groundbreaking Chest X-ray AI solution

This AI model accelerates decision-making by detecting and locating suspicious lesions in chest X-rays...Read more

22nd October, 2023


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


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