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Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 FDA drafts surgical robot testing expectations and leaves autonomy out of scope Marani Health clears the M•care system for fetal and maternal monitoring at home FDA books December 2 and 3 for a workshop on robot autonomy and remote teleoperation Glytec wins Breakthrough designation for insulin dosing software in newborns Perfuze bench study puts Millipede88 first-pass success at 88 percent in MCA models Precision Neuroscience raises $250M Series D and takes total funding to $430M FDA calls BD's kit correction Class I over recalled saline ampules from a supplier FDA early alert flags a loose cable that reboots React Health VOCSN ventilators Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 FDA drafts surgical robot testing expectations and leaves autonomy out of scope Marani Health clears the M•care system for fetal and maternal monitoring at home FDA books December 2 and 3 for a workshop on robot autonomy and remote teleoperation Glytec wins Breakthrough designation for insulin dosing software in newborns Perfuze bench study puts Millipede88 first-pass success at 88 percent in MCA models Precision Neuroscience raises $250M Series D and takes total funding to $430M FDA calls BD's kit correction Class I over recalled saline ampules from a supplier FDA early alert flags a loose cable that reboots React Health VOCSN ventilators

510(k)

Biolinq clears Shine for over-the-counter sale a year after its De Novo

MedDevice Startups Staff · 3 days ago · 2 min read · Via Biolinq (GlobeNewswire)

FDA cleared Biolinq Shine for over-the-counter sale, and the company announced it on September 24. The clearance covers adults 22 and older who are not taking insulin. Shine reports glucose ranges and trends, not values for dosing.

Shine already held a De Novo classification, granted in September 2025 for adults with type 2 diabetes not on insulin. That De Novo created the device type. The 510(k) a year later removes the prescription.

The sensor is a coin-sized forearm patch. Its microsensor array sits in the top layers of skin, which Biolinq puts at up to 20 times shallower than filament-based CGMs. A color-coded LED on the patch shows the range with no phone in the loop, and a companion app adds detail.

That labeling puts Shine in the retail biosensor aisle with Dexcom Stelo and Abbott Lingo rather than against prescription CGM. The San Diego company raised $100M in a Series C in April 2025, after $58M in 2024.

Questions & Answers

What did Biolinq get FDA clearance for in September 2026?

Biolinq received FDA 510(k) clearance on September 24, 2026 for over-the-counter sale of Biolinq Shine, its needle-free glucose sensor. The clearance covers adults 22 and older who are not taking insulin.

Is Biolinq Shine a continuous glucose monitor for insulin dosing?

No. Biolinq Shine reports glucose ranges and trends rather than quantitative values, so it is not intended for insulin dosing or acute treatment decisions. Biolinq sells it as a metabolic health wearable that also logs activity and sleep.

When did Biolinq Shine receive its De Novo classification?

FDA granted Biolinq Shine a De Novo classification in September 2025, for adults with type 2 diabetes who are not on insulin. The September 24, 2026 510(k) extended that device to over-the-counter sale.

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