Philips has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an automated merged B-lines feature for its Lumify ultrasound system.
The company said the automated merged B-lines feature can be used on all three Lumify transducers. It added that this feature can be used to evaluate the severity of lung conditions along with clinical and radiological information.
Philips has been working with the Biomedical Advanced Research and Development Authority (BARDA) on the POCUS system, with BARDA saying this most recent clearance marks the 74th FDA approval, clearance, and licensure for medical countermeasures supported by the authority under novel public-private partnerships.
The FDA clearance for the B-mode feature expands upon a previous 510(k) clearance for the B-lines counting algorithm that assesses lung injury. BARDA and Philips entered into a partnership in 2020 to expand the capabilities of the Lumify system. The FDA clearance is a step in BARDA's overarching strategy in its 2022-2026 strategic plan.
