Regulatory

FDA Approves Medtronic's PulseSelect™ for Atrial Fibrillation Treatment

Safe, efficient, and effective treatment for both paroxysmal and persistent atrial fibrillation...

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. ...

FDA Safety Communication Does Not Impact BD Syringes

Company Committed to Support U.S. Health Care Needs...

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....

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....

BD introduces next-generation needle-free blood draw technology

New peripheral line draw solution delivers first and only compatibility with integrated catheters...

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...

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....

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...