News

The Heartland Institute11d
Congress Looks at Fast-Tracking Drugs, Devices Approved in Other Countries
The legislation would allow the FDA to approve drugs and devices that have already been approved in other industrialized ...
FDA Cuts Threaten New Drugs as Reviewers Saddled With Extra Jobs
HHS Secretary Robert F. Kennedy Jr.’s sweeping layoffs across federal health agencies are disrupting the work of drug, ...
Indianapolis Business Journal13d
FDA upheaval worries local companies
The Trump administration’s recent announcement that it plans to eliminate about 3,500 FDA jobs is creating uncertainty among ...
Medical Device Network on MSN3d
FDA approves Medtronic’s Simplera Sync sensor for MiniMed system
The US FDA has granted approval for the use of Medtronic’s disposable Simplera Sync sensor with the MiniMed 780G system.
MedTech Dive4h
Medtronic seeks FDA nod for insulin pump, furthering Abbott collab
Receiving FDA clearance would allow Medtronic to pair its pumps with a glucose monitor being developed for the company by ...
Crain's Cleveland Business10h
Cleveland women's healthtech startup secures $3M, doubling initial target
The newly secured $3 million in funding will help to accelerate the company’s development and bring its flagship product, ...
AI in Software as Medical Devices (SaMD): Navigating Patent and Regulatory Challenges in the US, Europe
The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical ...
When AI In Medical Devices Evolves Faster Than Regulations: How Do We Keep Up?
The question is not whether AI will transform healthcare; it’s whether regulators can keep pace with that transformation.