{"id":"c766aef1-c6ef-4b93-8459-f4a9ecc72c7e","slug":"vitestro-aletta-fda-de-novo-2026-08-19","kind":"regulatory_action","headline":"FDA grants De Novo authorization to Vitestro Aletta, first standalone robotic blood draw device","summary":"The FDA granted De Novo classification to Vitestro Aletta, the first standalone robotic device that can draw blood from a patient arm without hands-on operator intervention. Clinical data showed Aletta achieves successful blood draw rates comparable to or better than trained human phlebotomists across a broad range of patients. The device includes onboard sensors that can pause the procedure and alert a supervising phlebotomist if unsafe conditions are detected.","occurredAt":"2026-08-19T00:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"55a81e13-fb85-4bd8-8951-c16d2bd50eff","dataCenterId":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"moderate","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":null,"regulatoryAction":"other","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":null,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"formFactor":null,"latitude":null,"longitude":null,"autonomyClass":null,"legalOutcomeClass":"unknown","createdAt":"2026-08-27T14:06:21.755Z","updatedAt":"2026-08-27T14:06:21.755Z","model":null,"deployment":null,"company":{"id":"55a81e13-fb85-4bd8-8951-c16d2bd50eff","name":"Vitestro","slug":"vitestro","description":"Dutch medical-robotics company; maker of Aletta, billed as the [World](/companies/world-labs)'s first autonomous robotic phlebotomy device, combining AI, ultrasound imaging, and robotics to locate veins and draw blood, with ~94.5% first-stick success and EU MDR approval. 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