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FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first

The Tracker / September 2026 / K262390

510(k) cleared

BoneXpert

Visiana · Sep 22, 2026 · K262390

FDA cleared the BoneXpert from Visiana on Sep 22, 2026 under K262390, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 13, 2026. The decision came 71 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Visiana in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262390?

K262390 is the FDA 510(k) for BoneXpert, submitted by Visiana. FDA's decision date was Sep 22, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the BoneXpert?

Visiana, based in Horsholm, is the applicant of record for K262390.

How long did the K262390 review take?

FDA received the submission on Jul 13, 2026 and issued its decision on Sep 22, 2026, 71 days later.

← All decisions in September 2026