Readings were mixed on what the ultimate impact will be on the medical device industry and on patient safety of FDA's 510(k) reform plan announced January 19.
Many device executives and analysts saw the agency's final decisions as a net positive for industry compared to last year's set of proposed 510(k) reforms. The tweaks, they said, respond to the aggressive lobbying by manufacturers and some members of Congress, and delay the more controversial changes for at least a number of months by pushing them over for consideration by the Institute of Medicine. Others say that the agency's game plan, while lacking in detail, should in no way be interpreted as soft on industry.
Readings were mixed on what the ultimate impact will be on the
medical device industry and on patient safety of FDA's 510(k)
reform plan announced January 19.
Many device executives and analysts saw the agency's final decisions as a net positive for industry compared to last year's...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on In Vivo for daily insights
Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.
Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access In Vivo, or if you love it how it is, now is the time to have your voice heard.
The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.
Annual survey of patients and professionals shows how attitudes to health system transformation are evolving and what stakeholders are demanding as acceptance of AI tools accelerates.
BioWales in London 2025 showcased the efforts healthtech innovators are making to meet investors on their own turf, illustrating changing attitudes and evolving needs.
Metsera CEO Whit Bernard applies an unconventional leadership philosophy to develop next-generation obesity therapeutics, including monthly GLP-1 injections and oral peptides.
