TGA approval for Uscom BP+ Central Blood Pressure
THE ROADHOUSE PHARMACY: Uscom (ASX: UCM) announced the listing of the company’s Uscom BP+ device on the Australian Register of Therapeutic Goods.
The Australian Therapeutic Goods Administration (TGA) lists devices which meet Australian Government standards of quality, safety, efficacy and timely availability on the Australian Register of Therapeutic Goods.
Listing on the TGA register is essential prior to sale of a medical device in Australia.
Uscom explained the Uscom BP+ uses patent protected suprasystolic oscillometry to measure the blood pressure at the heart, information previously only provided by cardiac catheterization, and which better predicts cardiovascular risk and provides better treatment guidance.
The company claims the patent protected Uscom suprasystolic oscillometric central blood pressure technology has advantages over simple sub systolic oscillometry, which only measures the cuff blood pressure in the arm.
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.
“Regulatory approval is becoming a significant hurdle for market entry as the regulatory process becomes increasingly complicated,” Uscom executive chairman Dr Rob Phillips said in the company’s announcement to the Australian Securities Exchange.
“We are delighted to have FDA, CE and now TGA approval for the Uscom BP+, and are currently preparing for Chinese CFDA submission.
“Australian Doctors are responsive to new and improved technologies and the Uscom supra systolic oscillometric central blood pressure device, the BP+, represents a breakthrough technology in the field.
“We are now targeting Hospitals, cardiovascular researchers, clinics and individuals with hypertension or heart failure that require highly accurate clinical blood pressure measurements and improved management.”
Website: www.uscom.com.au