Heart Force Medical Inc announced that it has received USFDA Clearance for its digital Ballistocardiograph (dBG).
Dr. Geoff Houlton, Heart Force Medical’s President and CEO commented, 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. We are currently evaluating a number of business options that will enable HFM to generate revenues for the dBG 300 as quickly as possible.
Dr. Edward Busse, Heart Force Medical’s Chief Medical Officer further commented, We have seen the benefits of this device in assessing cardiac performance in a range of individuals, now we must focus on addressing physicians’ and patients’ needs. We believe that the dBG 300 could provide significant benefit for monitoring patients in critical care as well as in assessing cardiac performance.