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de novo clearance

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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
colorful brain art model

FDA clears prescription migraine app from Click Therapeutics

Apr 17, 2025 11:35am
NICU

FDA clears vibrating pad to nudge breathing in preterm newborns

Apr 8, 2025 11:00am
Visby Medical at home STI test

Visby Medical nets FDA clearance for completely at-home STI test

Mar 28, 2025 12:00pm
FDA stop sign

FDA's novel device clearances slow to a crawl

Mar 27, 2025 11:30am
green bacteria

FDA clears first automated endoscope cleaning system

Mar 25, 2025 11:51am

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