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Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target 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 Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target 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

The Tracker / August 2026 / DEN250046

510(k) cleared

Aletta® Autonomous Robotic Phlebotomy Device (ARPD) (Gen1 US)

Vitestro · Aug 19, 2026 · DEN250046 · In the directory

FDA cleared the Aletta® Autonomous Robotic Phlebotomy Device (ARPD) (Gen1 US) from Vitestro on Aug 19, 2026 under DEN250046, a direct 510(k). The review panel was Unknown.

FDA logged the submission as received on Sep 26, 2025. The decision came 327 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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

Questions & Answers

What did FDA clear under DEN250046?

DEN250046 is the FDA 510(k) for Aletta® Autonomous Robotic Phlebotomy Device (ARPD) (Gen1 US), submitted by Vitestro. FDA's decision date was Aug 19, 2026, under product code SIW.

Who makes the Aletta® Autonomous Robotic Phlebotomy Device (ARPD) (Gen1 US)?

Vitestro, based in Utrecht, is the applicant of record for DEN250046. The company is listed in the MedDevice Startups directory.

How long did the DEN250046 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Aug 19, 2026, 327 days later.

← All decisions in August 2026