FDA Decisions & Milestones
FDA Decisions & Milestones
New technology needs a clear account of what regulators have decided, what the evidence shows and what is still being studied. This Reading Room area separates products authorized for use from those still under review.
Authorized for use
A robot draws the blood, a phlebotomist remains in charge
Aletta | De Novo authorized | FDA action: August 19, 2026 | Status checked: September 30, 2026
FDA authorized Aletta's robotic blood-draw device for adult outpatients, with trained phlebotomist oversight. This is permission to market the device within its authorized use, not proof of widespread deployment or a replacement for laboratory judgment.
Read Dr. Mohan's take: https://doctorsdocmd.com/4-aletta-robot-phlebotomy FDA order: https://www.accessdata.fda.gov/cdrh_docs/pdf25/DEN250046.pdf FDA announcement: https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-its-kind-robotic-blood-draw-device
Under review
Galleri: a favorable FDA panel vote, not approval
Galleri | Under review | Advisory panel: September 23, 2026 | Status checked: September 30, 2026
An FDA panel voted favorably on Galleri, but an advisory vote is not FDA approval. The next question is the complete diagnostic journey, including the trial evidence, follow-up and patient benefit.
Reading the status labels
"Approved", "cleared" and "authorized" describe different FDA pathways. Each entry names the actual action and its date. An advisory vote, Breakthrough Device designation, study authorization or registration is not permission to market a product for a new use. Research and marketing claims are labeled separately.
For education only. This page does not offer personal medical advice.