FDA to Accept Deidentified Real-World Evidence for Select Medical Device Applications
In new guidance FDA said it will accept real-world evidence (RWE) for certain medical device submissions without requiring that identifiable...
FDA
FDA clears Mode Sensors’ fluid monitoring wearable
According to a 2023 report from GlobalData, the wearable technology market is forecast to grow from $99.5bn in 2022 to...
FDA issues position on PFAS and PTFE in medical devices
Medtech manufacturers are increasingly launching PFAS-free catheters and other medical devices. The FDA said this week that it has found...
FDA Alerts Patients to Regularly Check Diabetes-Related Smartphone Device Alert Settings, Especially Following Phone Hardware or Software Changes
Date Issued: February 5, 2025The U.S. Food and Drug Administration (FDA) is alerting patients who use diabetes devices and their...
Cybersecurity | FDA
On December 29, 2022, the Consolidated Appropriations Act, 2023 ("Omnibus") was signed into law. Section 3305 of the Omnibus --...
FDA grants approval for trial of NEXTBIOMEDICAL’s Nexsphere-F
The trial will demonstrate the performance of the system in easing pain and improving mobility for knee osteoarthritis subjects. Credit:...
FDA Issues New Guidance For AI In Medical Devices
InnovationRx is your weekly digest of healthcare news. To get it in your inbox, subscribe here. getty This week, the...
FDA plan would alert public sooner on high-risk device recalls
Listen to the article 3 min This audio is auto-generated. Please let us know if you have feedback. The Food...
FDA names new head of medical device evaluation and quality
Listen to the article 3 min This audio is auto-generated. Please let us know if you have feedback. The Food...
