MINNEAPOLIS--(BUSINESS WIRE)--MedicalCV, Inc. (OTCBB:MCVI), www.medcvinc.com, announced today that it has received correspondence from the U.S. Food and Drug Administration commenting on the company’s 510(k) application for its minimally invasive surgical ablation system. The company expects to respond to such comments within the next 30 days. As a consequence of the continued review of the company’s application, the company no longer expects to receive 510(k) clearance on a timeline that would permit commercial launch of its minimally invasive system this calendar year.
