Opportunity
Federal Register #2026-20440
FDA Class II classification of HistoSonics’ Edison non-thermal focused ultrasound system
Buyer
Department of Health and Human Services / Food and Drug Administration
Posted
October 06, 2026
Identifier
2026-20440
The FDA issued a regulatory classification for HistoSonics’ Edison System, rather than a request to purchase equipment or services. - Government buyer: U.S. Department of Health and Human Services, Food and Drug Administration (FDA); no specific office is identified. - OEM: HistoSonics, Inc., manufacturer of the Edison System. - Product: Focused ultrasound system for non-thermal, mechanical ablation of soft tissue. It is not intended to thermally ablate tissue; no part number or purchase quantity is specified. - Classification and requirements: Class II medical device subject to special controls, including clinical, animal, and non-clinical performance testing; electrical safety and electromagnetic compatibility evidence; biocompatibility assessment; software verification, validation, and hazard analysis; human-factors testing; and specified labeling. - No procurement line items, services, contract value, or period of performance are identified.
Description
The FDA is classifying the focused ultrasound system for non-thermal, mechanical tissue ablation as a Class II medical device subject to special controls. The device uses focused ultrasound to mechanically ablate soft tissue and is not intended to thermally ablate tissue. The order codifies the classification and identifies requirements including clinical, animal, and non-clinical performance testing, electrical safety and electromagnetic compatibility, biocompatibility, software and human-factors testing, and labeling. FDA states that the classification provides reasonable assurance of safety and effectiveness and is intended in part to reduce regulatory burdens and enhance patient access to innovative devices.