Article Name Regulatory
Postmarket Surveillance of Medical Devices: Ensuring Safety and Efficacy
Medical devices play a crucial role in modern healthcare, ranging from simple tools like thermometers to complex devices such as pacemakers and imaging equipment. Ensuring the safety and efficacy of these devices throughout their lifecycle is of paramount importance.
11th December, 2023
FDA Safety Communication Does Not Impact BD Syringes
Company Committed to Support U.S. Health Care Needs
04th December, 2023
FDA Greenlights Medtronic's Minimally Invasive Device for Hypertension Treatment
Medtronic plc a global leader in healthcare technology, announced that the United States Food and Drug Administration (FDA) has approved the Symplicity Spyral™ renal denervation (RDN) system, also known as the Symplicity™ blood pressure procedure, for the treatment of hypertension. With this approval, Medtronic will immediately begin commercialization.
20th November, 2023
MONARCH Platform for Bronchoscopy Receives Regulatory License for China
The MONARCH™ Platform is the first minimally invasive, robotic-assisted technology approved for bronchoscopy in a country with significant burden of lung cancer.
15th November, 2023
First and only metered-dose cannabis inhaler to obtain ARTG approval in Australia
A historic milestone in the field of medicinal cannabis treatment
06th November, 2023
BD introduces next-generation needle-free blood draw technology
New peripheral line draw solution delivers first and only compatibility with integrated catheters
06th November, 2023
Boston Scientific's AGENT™ Drug-Coated Balloon Outperforms Uncoated Balloon in IDE Trial
Data from first coronary DCB study in U.S. meet 12-month primary endpoint, demonstrate low adverse event rates with AGENT DCB
26th October, 2023
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 officially received FDA 510K approval.
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
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
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 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
Medtech Special
© 2023 MM Activ Sci-Tech Communications. All rights reserved | Disclaimer