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Medical Devices
FDA Fast-Tracks AI Integration: Revolutionizing Scientific Reviews by June 2025
The FDA is rolling out AI tools agency-wide by June 30, 2025, to streamline scientific reviews and reduce task time from days to minutes.
Madeleine DeSpirito
May 81 min read
FDA Modernizes 510(k) Pathway: New Tools and Standards for Safer Devices
The FDA is modernizing the 510(k) Premarket Notification Program with new submission pathways, digital tools, and updated guidances to enhance medical device safety and effectiveness.
Madeleine DeSpirito
May 81 min read
Medtronic Secures FDA Approval for World’s Smallest Defibrillation Lead
Medtronic has announced FDA approval of its Omniasecure defibrillation lead, a device that connects to implantable cardioverter...
Madeleine DeSpirito
May 51 min read
Senseonics Joins Sequel to Bring 1-Year CGM to Insulin Dosing System
Senseonics is partnering with Sequel Med Tech to integrate its year-long Eversense 365 continuous glucose monitor with Sequel’s automated insulin delivery system, Twiist.
Madeleine DeSpirito
May 51 min read
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