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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / October 2026 / K262378

510(k) cleared

Dr.AlignNavi

InnoDtech, Inc. · Oct 7, 2026 · K262378

FDA cleared the Dr.AlignNavi from InnoDtech, Inc. on Oct 7, 2026 under K262378, a traditional 510(k). The device falls under product code PNN, Orthodontic Software, regulated at 21 CFR 872.5470 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jul 13, 2026. The decision came 86 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for InnoDtech, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262378?

K262378 is the FDA 510(k) for Dr.AlignNavi, submitted by InnoDtech, Inc.. FDA's decision date was Oct 7, 2026, under product code PNN (Orthodontic Software).

Who makes the Dr.AlignNavi?

InnoDtech, Inc., based in Gwangju, is the applicant of record for K262378.

How long did the K262378 review take?

FDA received the submission on Jul 13, 2026 and issued its decision on Oct 7, 2026, 86 days later.

← All decisions in October 2026