Diagnostics and medtech.
Point-of-care testing is diagnostic testing performed at or near the patient, in a physician's office, clinic, or emergency room, rather than a central laboratory, and its legal boundary in the United States is set by CLIA. The FDA categorizes tests as waived, moderate, or high complexity; only…
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…
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…
Medical device trials run on an Investigational Device Exemption, the instrument that "allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data," per FDA — and all such evaluations, unless exempt, "must have an approved IDE before the…
AI-enabled medical imaging devices are regulated as medical devices whose software uses artificial intelligence, authorized through FDA's existing premarket pathways and tracked on the public AI-Enabled Medical Device List. The list exists, per FDA, to identify AI-enabled devices authorized for…