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

THE TAPE

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 Wandercraft opens Eve exoskeleton sales with Medicare code K1007 in hand Medtronic clears a robotic LigaSure vessel sealer for Hugo, nine months after the robot FDA clears Neptune Medical's Triton 1 robotic colonoscope after a 50-patient study FDA takes pathogen-agnostic sequencing to an advisory panel on November 19 CMS adds heart failure and COPD tracks to the ACCESS model, launching spring 2027 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 Wandercraft opens Eve exoskeleton sales with Medicare code K1007 in hand Medtronic clears a robotic LigaSure vessel sealer for Hugo, nine months after the robot FDA clears Neptune Medical's Triton 1 robotic colonoscope after a 50-patient study FDA takes pathogen-agnostic sequencing to an advisory panel on November 19 CMS adds heart failure and COPD tracks to the ACCESS model, launching spring 2027

The Directory / Diagnostics & IVD

Diagnostics & IVD

Aptitude Medical Systems

Goleta, CA · Unknown · 510(k) cleared

Makes the Metrix handheld molecular diagnostic platform for point of care and over the counter respiratory and STI testing. Spun out of UC Santa Barbara.

FDA DECISIONS ON FILE

1 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Aug 7, 26	K253453510(k)	Metrix COVID Test; Metrix COVID Test Pro	Aptitude Medical Systems, Inc.	Microbiology	QWB

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Aptitude Medical Systems

FDA DECISIONS ON FILE

COVERAGE