News

FDA warning hits Minnesota-made infusion pumps for missing regulatory checks
California-based ICU Medical failed to submit proper documents for significant changes to two devices made in Minneapolis, ...
Food Business News7h
FDA cuts might lead to fewer inspections
HAMPTON, VA. — Food plant inspections by the US Food and Drug Administration might be reduced as the result of deep staffing ...
JD Supra1d
Federal Court Blocks FDA’s Final Rule on LDTs: Key Considerations for Clinical Labs
The US District Court for the Eastern District of Texas issued a pivotal ruling in the consolidated lawsuit American Clinical Laboratory ...
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, ...
News-Medical.Net on MSN11h
Mursla Bio receives FDA breakthrough device designation for EvoLiver test
Mursla Bio, a leader in Extracellular Vesicle (EV) science on a mission to significantly improve cancer outcomes for at-risk ...
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.
National Law Review12d
District Court Strikes Down FDA’s LDT Rule, Opens the Door for Challenges to FDA’s Regulation of Other “Services” as Medical Devices
On Monday, March 31, a court in the Eastern District of Texas found unlawful and vacated the Food and Drug Administration’s ...
Endovascular Today5h
CereVasc eShunt Receives Breakthrough Device Designation for Use in Pediatric Patients to Treat Communicating Hydrocephalus
CereVasc, Inc. announced it has received its second FDA Breakthrough Device designation for the investigational eShunt system ...