MedTech Spectrum

Article Name Regulatory

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 narrowest and thinnest plating system amongst all plates on the global spine market.

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 provide exceptional imaging at the right dose for visible impact in complex cardiology interventions regardless of patient size.

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

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

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 safety profile to other fenebrutinib trials. The late-breaking data were featured in an oral presentation at the 9th Joint ECTRIMS-ACTRIMS Meeting (European and Americas Committees for Treatment and Research in Multiple Sclerosis).

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 implants and abutments.

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

03rd October, 2023

4WEB Medical Receives 510k Clearance to Market New Integrated Cervical Plate

Company Continues to Build Momentum with Most Recent Portfolio Expansion.

28th September, 2023

Saluda Medical Receives FDA Approval for Evoke® System MRI Labeling

Patients implanted with the Evoke® System now eligible for full-body MRI scans

27th September, 2023

Qure.ai receives 510(k) FDA clearance for chest X-ray solution for Pneumothorax and Pleural Effusion

A monumental step towards getting healthcare AI to augment critical care and emergency care

18th September, 2023

Genesis MedTech Introduces China's First NPMA-Approved Antibacterial Sutures

Genesis MedTech, a leading medical device company, announced that its absorbable sutures with antibacterial protection have successfully obtained approval from the China's National Medical Products Administration (NMPA) for market release.

12th September, 2023

Alveofit receives US FDA clearance for alveoair spirometer

Marking a significant advancement in respiratory care

11th September, 2023

"We are coming up with CoEs for health science & medical devices": Priyank Kharge

Priyank Kharge, Minster for IT BT, Government of Karnataka speaking at the Global Innovation Alliance (GIA) Partners Meet held on August 28, 2023 in Bangalore

07th September, 2023

Bio-Gate AG signs LOI with North American medical device manufacturer for trauma implants

Bio-Gate AG (ISIN DE000BGAG981), a leading provider of innovative technologies and individual solutions for health and hygiene, has concluded a preliminary agreement (LOI, Letter-of-Intent) with a North American medical device manufacturer focusing on the trauma sector. The medical device manufacturer intends to use Bio-Gate's "HyProtectTM " coating process for its own implants in human medicine following the FDA approval process.

22nd August, 2023

CathVision's AI EP Recording System Gains FDA Clearance for Cardiac Ablation Success Measurement

ECGenius System with CARDIALYTICS Algorithms Provides Unprecedented Levels of Automated Analyses Derived from High-Fidelity, Low-Noise Cardiac Signals

16th August, 2023

CareBand Obtains US Patent for IoT Wearable System Safeguarding Vulnerable Individual

CareBand, a pioneer in low-powered location-based health and safety wearable solutions, celebrates the granting of US Patent No 11,714,197. This milestone further strengthens CareBand's position as a leading innovator in the rapidly growing LPWAN market.

16th August, 2023