Becker's ASC

Medical Device Industry Generally Positive About FDA’s Proposed Changes to Medical Device Approval Process

The medical device industry has generally expressed satisfaction with the Food & Drug Administration’s move to revise the 510(k) device approval process, according to a Mass Device news report. • ...

Abbott secures FDA approval for CardioMEMS HERO device

Abbott has secured the US Food and Drug Administration (FDA) approval for its next-generation CardioMEMS HERO device, which ...
JD Supra

UK Proposes Approving Medical Devices Based on Approval in Other Countries

Device manufacturers may soon have access to a new framework for marketing and selling medical devices in the United Kingdom. On May 21, 2024, the UK Medicines and Healthcare products Regulatory ...
Seeking Alpha

Envoy Medical Receives FDA Approval To Initiate Pivotal Clinical Study for Breakthrough Hearing Device

The Acclaim® Fully Implanted Cochlear Implant is differentiated from existing cochlear implants and may offer new option for hearing loss patients WHITE BEAR LAKE, Minnesota, Nov. 01, 2024 (GLOBE ...

FDA Clearance for HeartBeam (NASDAQ: BEAT) Highlighted in Medical Device Approvals Roundup

HeartBeam (NASDAQ: BEAT) was among the medical device companies highlighted in a Jan. 8 report by Modern Healthcare by ...
Becker's ASC

Is There a Middle Ground for Medical Device Approval?

Bloggers at the Millennium Research Group’s blog compared the FDA and the European CE mark and the effects on innovation in both markets. According to industry experts the MRG authors interviewed, the ...
Becker's Hospital Review

Medical devices approved in EU before US have more safety issues, study finds

Safety issues occur more often in medical devices first approved by the European Union when compared to devices first approved in the U.S., according to a recent study published in The BMJ. In the EU, ...
PBS

FDA-approved medical device raising safety concerns

Americans rely on the Food and Drug Administration to make sure that medical devices are safe. Reporting by KFF Health News has raised questions about how the FDA has dealt with some products, ...
PBS

One medical device is raising questions about FDA’s approval process

Americans rely on the Food and Drug Administration to make sure that medical devices are safe. Reporting by KFF Health News has raised questions about how the FDA has dealt with some products, ...
MD&M East

Mexico’s Shortened Regulatory Timetable Attracts Medical Device Manufacturers

An accelerated regulatory pathway in Mexico has positioned the country as a priority launch market for medical devices. Guerreschi: This pathway is designed to reduce approval timelines by the Federal ...
Univeristy of Iowa Daily Iowan

Navigating Regulatory Strategies in Korea’s Medical Device Sector

South Korea’s medical device market is rapidly expanding, driven by technological innovations and increasing healthcare demands. As the market grows, understanding Korean medical device regulations is ...