For how we live.
A final order published 5 November classifies wearable devices that apply targeted mechanical vibration to the skeleton to reduce loss of bone strength or density, setting the evidence such products must meet.
A final order published 5 November creates a class II category for prognostic software that weighs multiple clinical inputs to gauge the chance of progression from mild cognitive impairment — for adjunctive use only.
A final order published 5 November creates a device category for digital cervical cytology imaging systems with AI, letting future versions clear through the 510(k) route instead of the strictest class III review.
A final order published 9 October classifies systems that let people collect their own specimens for non-viral STI testing as class II, moving them out of the automatic class III that demands premarket approval.
A final order codifies Class II status for high-throughput DNA sequencing systems that detect germline mutations in cancer genes, built on Invitae's panel. It becomes a predicate other makers can clear against.
A final order codifies a new Class II category for systems that destroy soft tissue with sound rather than heat, built on HistoSonics Edison System. It becomes a predicate other makers can clear against.
The Aletta still needs a trained supervisor in the room, but it locates the vein, inserts the needle and fills the tubes on its own — and one person can now watch three of them at once.