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de novo clearance
MedTech
FDA clears Clairity's 5-year breast cancer risk prediction tool
The FDA’s de novo clearance paves the way for Clairity to launch the risk prediction platform with leading health systems through 2025.
Heather Landi
Jun 5, 2025 1:00pm
FDA clears prescription migraine app from Click Therapeutics
Apr 17, 2025 11:35am
FDA clears vibrating pad to nudge breathing in preterm newborns
Apr 8, 2025 11:00am
Visby Medical nets FDA clearance for completely at-home STI test
Mar 28, 2025 12:00pm
FDA's novel device clearances slow to a crawl
Mar 27, 2025 11:30am
FDA clears first automated endoscope cleaning system
Mar 25, 2025 11:51am