Signostics Receives FDA Clearance For World's Smallest Ultrasound Product

Main Category: MRI / PET / Ultrasound
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 20 May 2009 - 2:00 PDT

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Pioneering medical device company Signostics announced it has secured clearance from the U.S. Food and Drug Administration (FDA) for its palm-sized personal ultrasound device, the 'Signos'.

Signostics has developed a cost-effective device that for the first time makes it affordable for individual health professionals to use ultrasound in their clinical practice. Just as handheld devices transformed the business world, it is anticipated the Signos will change the way healthcare professionals practice medicine.

Retailing at a fraction of the cost of larger machines, the Signos is the world's smallest and lightest ultrasound device. With a weight of approximately half a pound, its portability and low price point appeals to a large range of medical markets, including emergency medicine, primary care, remote healthcare, critical care, pediatrics, musculo-skeletal, palliative care and sports medicine. This breakthrough product is the first ultrasound platform technology that clinicians can place in their pocket or wear around their neck like a stethoscope.

The device delivers high-resolution images anywhere, at any time for general medical applications, including: abdominal assessments such as bladder, abdominal aortic aneurysm screening, and trauma assessment; musculoskeletal; and basic obstetrics, such as pregnancy viability and fetal positioning.

According to McGregorTan Research in their 2005 Market Assessment, the global personal ultrasound market is estimated to be worth around $3 billion, with the U.S. market worth about $1 billion.

"Securing FDA clearance is a huge milestone for our company," Dr. Bartlett said. "The global financial crisis over the last six months has put pressure on health costs around the world, with a need for more affordable medical devices that can deliver results rapidly and conveniently. The 'Signos' meets the requirement."

"The level of physician interest in the Signos at industry events and amongst industry leaders has been remarkable, and we are very optimistic about the sales outlook for the company."

Signostics has received funding from angel investors, Australian government grant providers and Playford Capital. The company will shortly close a round of funding at almost US$4 million, having raised a total of US$12 million to date.

The brainchild of physician-engineer Dr. Neil Bartlett, Signostics was established in Adelaide, Australia in January 2005. Signostics employs a cutting edge development team including physicians, sonographers as well as biomedical, electronic and software engineers. Signostics' global sales and marketing headquarters is located in the United States in Silicon Valley, California.

Source: Signostics

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