• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Heart Force Medical Inc. Receives USFDA 510(k) Clearance of Its dBG 300 Digital Ballistocardiograph

Posted on: Tuesday, 4 August 2009, 13:40 CDT

VANCOUVER, Aug. 4 /PRNewswire/ - Heart Force Medical Inc., a Vancouver-based company that is developing a non-invasive cardiac performance monitor, announced today that it has received USFDA Clearance for its digital Ballistocardiograph (dBG (TM)).

"This further confirms the value of the dBG. We already have Health Canada approval. Receiving certification from the USFDA, which is accepted as the International Standard for regulatory compliance, gives us unfettered access to the US Market. This allows us to fully define how our product will be best used to assist physicians in their assessment of patients' cardiac performance", said Dr. Geoff Houlton, Heart Force Medical's President and CEO. "We are currently evaluating a number of business options that will enable HFM to generate revenues for the dBG 300 as quickly as possible."

"We have seen the benefits of this device in assessing cardiac performance in athletes, now we must focus on addressing physicians' and patients' needs. We believe the dBG 300 could provide significant benefit for monitoring patients in critical care as well as in assessing cardiac performance in a wide variety of patients and situations", said Dr. Edward Busse, Heart Force's Chief Medical Officer.

About Heart Force

Privately-held Heart Force Medical Inc. has its headquarters in Vancouver and is in the business of developing non-invasive medical devices to assess cardiac performance by measuring and monitoring the mechanical action of the heart. The Heart Force dBG 300 device is a standalone, portable unit containing sophisticated digital sensors.

SOURCE Heart Force Medical Inc.

Source: PR Newswire

More News in this Category