FDAnews Device Daily Bulletin

Edap Withdraws 510(k) Device Application to Redo Clinical Data

July 24, 2017

Edap has withdrawn its application for 510(k) clearance from the FDA for its Focal One prostate cancer device.

The French company announced the decision following talks with the agency, noting that alterations to biopsy protocol are complicating comparing biopsy data under the current application. The company plans to submit a new application with new clinical data.

The company will also submit a 510(k) filing for its Ablatherm Fusion device for prostate tissue ablation.