AUSTRALIAN medical device company Uscom says its BP+ device has been listed on the Australian Register of Therapeutic Goods.
The list contains devices which meet Australian Government standards of quality, safety, efficacy and timely availability. Listing on the register is an essential part of the process to get a medical device on sale in Australia.
The Uscom BP+ uses suprasystolic oscillometry to measure the blood pressure at the heart, information which provides better predictions of cardiovascular risk and provides better treatment guidance. This information was previously only provided by intrusive cardiac catheterisation.
The Uscom suprasystolic oscillometric central blood pressure technology has advantages over simple sub systolic oscillometry, which only measures the cuff blood pressure in the arm.
According to Uscom, as the regulatory process becomes increasingly complicated, regulatory approval is becoming a significant hurdle for market entry.
The TGA listing now means the Uscom BP+ can be sold in Australia by distributors and directly by the Company to Hospitals, clinics, researchers and consumers concerned with improved management of hypertension and other diseases related to blood pressure abnormalities such as heart failure.
The current global BP device market is estimated at approximately $2b USD and growing at 11.5% per year.