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Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

FDA pays Cognita Imaging $1.29M to test whether a jury of LLMs can grade radiology AI CurvaFix puts a 1.45 percent removal rate on its first 3,800 pelvic implants Science Corporation names Darius Shahida president as PRIMA starts selling in Europe Aptitude's Metrix COVID test clears 510(k) with three times the sensitivity of its EUA version Sempresto's smartphone epinephrine injector heads for a 505(b)(2) after FDA answers 10 pre-IND questions FDA drafts a guided PMA submission template and sets a November 17 comment deadline FDA keeps radiology AI on the 510(k) path and denies Harrison.ai's exemption petition FIZE Medical takes a first close on a $20M Series B with its Japanese distributor co-leading Emanate clears Perio PODS, an at-home hydrogel dressing for after scaling and root planing FDA pays Cognita Imaging $1.29M to test whether a jury of LLMs can grade radiology AI CurvaFix puts a 1.45 percent removal rate on its first 3,800 pelvic implants Science Corporation names Darius Shahida president as PRIMA starts selling in Europe Aptitude's Metrix COVID test clears 510(k) with three times the sensitivity of its EUA version Sempresto's smartphone epinephrine injector heads for a 505(b)(2) after FDA answers 10 pre-IND questions FDA drafts a guided PMA submission template and sets a November 17 comment deadline FDA keeps radiology AI on the 510(k) path and denies Harrison.ai's exemption petition FIZE Medical takes a first close on a $20M Series B with its Japanese distributor co-leading Emanate clears Perio PODS, an at-home hydrogel dressing for after scaling and root planing

The Directory / Respiratory & Sleep

Happy Health

Austin, TX · Series A · 510(k) cleared

The Happy Ring is a sensor ring cleared to diagnose obstructive sleep apnea at home. The company is building a home care platform around it.

FDA DECISIONS ON FILE

1 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Sep 3, 26	K254000510(k)	Happy Health Blood Pressure Monitor	Happy Health, Inc.	Cardiovascular	DXN

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