WHERE ARE YOU?

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

510(k)

Aptitude's Metrix COVID test clears 510(k) with three times the sensitivity of its EUA version

MedDevice Startups Staff · 3 days ago · 2 min read · Via Aptitude Medical Systems release

Aptitude Medical Systems won 510(k) clearance for the next generation of its Metrix COVID test on September 16. The clearance covers over the counter use and professional use in CLIA waived settings. It is the company's first 510(k). The earlier Metrix test reached the market under an emergency use authorization.

The new version is about three times more analytically sensitive than the EUA product and returns results 30 percent faster, according to the company. BARDA paid for part of the development under contract 75A50123C00013. Aptitude is a UC Santa Barbara spinout based in Goleta, California.

A Metrix COVID/Flu test sits under 510(k) review, with RSV, strep and sexually transmitted infection assays behind it. FDA is ending COVID-19 emergency use authorizations on December 26. Every EUA holder in respiratory diagnostics faces the same arithmetic: a cleared product with clinical data, or nothing to sell in January.

Questions & Answers

What did FDA clear for Aptitude Medical Systems in September 2026?

FDA granted Aptitude Medical Systems 510(k) clearance on September 16, 2026 for the next generation Metrix COVID test. It covers over the counter use and professional use in CLIA waived settings.

How much more sensitive is the new Aptitude Metrix COVID test?

Aptitude says the cleared Metrix COVID test has roughly three times the analytical sensitivity of the version it sold under emergency use authorization, and returns results 30 percent faster.

Who funded development of the Aptitude Metrix platform?

BARDA supported development of the Aptitude Medical Systems Metrix platform under contract 75A50123C00013. Aptitude is based in Goleta, California.

← Back to Newly Cleared