Diagnostics and medtech.
A continuous glucose monitor is a wearable sensor that measures glucose in interstitial fluid around the clock and streams values to a smartphone app. The category hit a regulatory milestone on March 5, 2024, when FDA cleared Dexcom's Stelo as the first over-the-counter continuous glucose…
Total laboratory automation integrates a clinical laboratory's pre-analytical, analytical, and post-analytical phases into connected tracks and systems, per a 2025 review in the Annals of Laboratory Medicine. The review names Abbott, Roche, Siemens, and Beckman Coulter as the companies…
Software as a Medical Device is software intended for one or more medical purposes that performs those purposes without being part of a hardware medical device, per the definition FDA adopted from the International Medical Device Regulators Forum. The category covers standalone products, from…
Surgical robotics is the use of computer-controlled manipulators, operated by a surgeon at a console, to position instruments and cameras inside the patient. The systems in clinical use are not autonomous: they act as fully controlled remote extensions of the surgeon, master-slave manipulators…
Device reimbursement in the United States runs through Medicare's coverage machinery: an item must fall within a statutory benefit category and be reasonable and necessary for diagnosis or treatment before payment follows. National coverage determinations are made through an evidence-based…