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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

510(k)

RingConn clears blood oxygen measurement on its smart ring under K260490

MedDevice Startups Staff · Oct 10 · 2 min read · Via PR Newswire

RingConn cleared non-invasive blood oxygen measurement on its smart ring under K260490. The company announced the 510(k) on October 10 and said FDA found the measurement substantially equivalent to legally marketed predicates.

The ring reads SpO2 with a photoplethysmography sensor, the same optical method behind consumer finger and wrist oximeters. RingConn belongs to Shenzhen Ninenovo Technology, founded in 2021, and already carries CE, FCC, UKCA, MIC and RCM marks across more than 190 countries. The company says clinical research is still running to build validation data.

The release gives no accuracy figure. For a pulse oximeter that number is the whole conversation, and the 510(k) summary will carry a root mean square error against arterial blood gas even where the press release skips it. Read that before the marketing copy.

Questions & Answers

What did RingConn get FDA clearance for?

RingConn received FDA 510(k) clearance under K260490 for non-invasive blood oxygen (SpO2) measurement on its smart ring. The company announced the clearance on October 10, 2026.

Who makes the RingConn smart ring?

RingConn is a brand of Shenzhen Ninenovo Technology Limited, founded in 2021. The ring is sold in more than 190 countries and carries CE, FCC, UKCA, MIC and RCM marks.

How does the RingConn ring measure blood oxygen?

The RingConn smart ring measures SpO2 with a photoplethysmography sensor, the same optical method used in consumer finger and wrist pulse oximeters. RingConn says clinical research is continuing to build validation data.

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