FDA: Transducer Test A Key Element In Ultrasound Guidance

The US agency lifted 510(k) requirements for many diagnostic ultrasounds via a June guidance document. But a new focus on transducer element safety is still posing some challenges, FDA staff said during a recent webinar on the policy changes.

Past adverse events prompted the US Food and Drug Administration to recommend additional transducer checks in a recent ultrasound guidance document, an agency official said during a recent webinar.

Shahram Vaezy, a biomedical engineer in the FDA’s Center for Devices and Radiological Health (CDRH), discussed “Marketing Clearance of...