Article Name Regulatory

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 Symplic...Read more

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....Read more

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...Read more

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...Read more

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...Read more

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 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 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

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