MedTech Spectrum

Article Name Regulatory

MicroPort EverPace's Columbus™ 3D EP Navigation System Receives CE MDR Certification

MicroPort EverPace's latest generation Columbus™ 3D EP Navigation System (Columbus™) has recently received CE MDR approval.

06th February, 2024

FDA Reveals Revolutionary Overhaul of Quality Management System Regulations for Medical Devices in Pursuit of Global Harmonization

In a significant stride towards harmonization with international standards, the U.S. Food and Drug Administration (FDA) announced the issuance of a final rule amending the Quality System (QS) Regulation, titled "Quality Management System Regulation (QMSR)," on January 31, 2024.

05th February, 2024

Enhatch Receives FDA Clearance for AI-Enhanced TKA Instrumentation System

Enhatch Inc. is excited to announce the U.S. Food and Drug Administration (FDA) 510(k) clearance of a patient specific instrumentation system for Total Knee Arthroplasty. This state-of-the-art system is redefining total knee arthroplasty with its AI-driven approach, encompassing both anatomic model generation and treatment planning

26th January, 2024

Olympus Closes the Acquisition of Korean Gastrointestinal Stent Company, Taewoong Medical Co., Ltd

Olympus Strengthens its Medical Portfolio with Successful Acquisition of Taewoong Medical Co., Ltd, a Leading Korean Gastrointestinal Stent Company

24th January, 2024

Aya Healthcare Expands into UK with ID Medical Acquisition

Aya Healthcare's Global Expansion: ID Medical Acquisition Marks Strategic Entry into the UK Healthcare Market

17th January, 2024

3M receives $34.2 million award to improve treatment of traumatic wounds from point-of-injury to hospital

Advancing Trauma Care: 3M Secures $34.2 Million Grant to Enhance Treatment of Traumatic Wounds Throughout the Entire Healthcare Journey

12th January, 2024

Lucem Health Launches Reveal for Faster AFib-Related Stroke Treatment

Groundbreaking Solution Identifies Undiagnosed AFib and Speeds Treatments Proven to Prevent Strokes

18th December, 2023

FDA Approves Medtronic's PulseSelect™ for Atrial Fibrillation Treatment

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

14th December, 2023

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