FDA authorized Vitestro's Aletta on August 19 through the De Novo pathway, and took the rare step of issuing its own press release. Aletta places the tourniquet and finds a vein with near-infrared imaging and Doppler ultrasound. It then cleans the skin, inserts the needle, swaps collection tubes and applies the bandage, with no operator's hands involved. One phlebotomist can supervise up to three units.
FDA said successful draw rates were comparable to or better than trained phlebotomists when the device proceeds with a stick. That held across skin tones and patients with difficult access, and device-related adverse events were uncommon and mild. MassDevice reported a 94.5% first-stick success rate from the European trial and mild adverse events in 0.6% of patients. The grant sets special controls for labeling, performance testing and clinical testing that future 510(k)s in the category will have to follow.
Vitestro, based in Utrecht, closed an oversubscribed $70M Series B on March 10. Labcorp Venture Fund, Mayo Clinic and Sutter Health led as strategics, joined by InterVest, PGGM, EIC Fund and Intuitive co-founder Fred Moll. Aletta has held a CE mark since 2024 with a limited European release. CEO Toon Overbeeke said a U.S. multicenter study will precede commercial availability, with manufacturing scale-up already under way.
An FDA press release for a De Novo is rare. CDRH director Michelle Tarver said the authorization advances devices that help meet a critical public health need. The labs that led the Series B are the ones with that staffing problem.