BioCentury
ARTICLE | Clinical News

Biofield regulatory update

March 3, 1997 8:00 AM UTC

The FDA did not accept for filing BZET's PMA for the Alexa 1000 System for breast cancer diagnosis, citing deficiencies in the application. BZET does not yet know whether it will be required to conduct additional trials. The company will seek a meeting with the FDA to discuss the deficiencies.

The FDA cited issues concerning the study design and the development and selection of the algorithms used on the supporting data set. The agency also stated that a clinical trial design should include the impact on patient management. ...