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Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Modular Medical clears software changes to the Pivot patch pump before its Q4 launch Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Vara wins first CE mark for AI that reports mammograms as normal without a radiologist Stryker to buy ZuriMED and its FiberLocker rotator cuff patch Novocure tells the SEC an August intrusion exposed data on more than 1,400 patients Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Modular Medical clears software changes to the Pivot patch pump before its Q4 launch Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Vara wins first CE mark for AI that reports mammograms as normal without a radiologist Stryker to buy ZuriMED and its FiberLocker rotator cuff patch Novocure tells the SEC an August intrusion exposed data on more than 1,400 patients

510(k)

Modular Medical clears software changes to the Pivot patch pump before its Q4 launch

MedDevice Startups Staff · 4 days ago · 2 min read · Via Modular Medical release

Modular Medical said on September 3 that FDA cleared a set of software changes to Pivot, its tubeless insulin patch pump. The headline change is customizable bolus dosing, which lets a user set how much insulin each button press delivers. The clearance also covers an updated user interface and other software upgrades.

Pivot itself cleared in April 2026. The San Diego company (Nasdaq: MODD) is aiming at people with diabetes who have never adopted a pump, and it delivers basal and bolus insulin over a three-day wear period. CEO Jeb Besser said the clearance arrived in advance of a planned fourth quarter launch.

The sequencing is worth copying. Clear the device on the smallest software configuration you can defend, launch, then file the feature set as a follow-on 510(k) against your own predicate. Each round is a narrower review than trying to clear the full roadmap at once, and the second submission has real use behind it.

Questions & Answers

What did Modular Medical get FDA clearance for in September 2026?

FDA cleared software enhancements to Modular Medical's Pivot tubeless insulin patch pump on September 3, 2026. The changes include customizable bolus dosing, an updated user interface and other software upgrades.

When will Modular Medical launch the Pivot insulin patch pump?

Modular Medical plans a full commercial launch of Pivot in the fourth quarter of 2026. The pump itself received its original FDA 510(k) clearance in April 2026.

What is the Modular Medical Pivot patch pump?

Pivot is a tubeless insulin patch pump from Modular Medical (Nasdaq: MODD) of San Diego. It delivers continuous subcutaneous basal and bolus insulin over a three-day wear period.

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