Smartphone Ultrasound Hits Market After Regulatory Delays

A smartphone-enabled ultrasound device is on the market after lengthy regulatory delays, showing an emerging need for balance between federal regulators, medical device manufacturers, and the pace of technology.

The device allows healthcare professionals to perform ultrasounds using a smartphone with a plug-in wand. It received approval from the U.S. Food and Drug Administration in February, after a lengthy wait, and then it took manufacturer Mobisante eight months to implement FDA-mandated controls.

Due to the gap between conception and commercial debut of Mobisante's mobile ultrasound, the device only works with the two-year-old Toshiba Windows Mobile TG01 phone and requires a USB 2.0 probe for the port. As a result, it isn't compatible with widely used iPhones and Android phones.

In July, the FDA released guidelines regarding the use of medical apps in practicing medicine, basically saying that these apps turn smartphones and tablets into "medical devices," which are then subject to the regulatory body's approval process.

The FDA's main regulatory aim is public safety, a desire that's shared by device makers and healthcare professionals alike. However, a disconnect may be growing as a lengthy approval process goes head-to-head with lightning-fast advances in mobile technology.

The FDA approval process for drugs and medical devices has been known to take years and be costly for manufacturers. The FDA clearance process for the Mobisante device may have cost the company hundreds of thousands of dollars.

Use of smartphones, tablets, and other mobile devices is increasing in health and hospital settings. At the same time, health costs are growing and large hospital systems, clinics and private practices are looking for ways to save money, creating a market for mobile medical device makers estimated to be worth $2 billion.

The smartphone-enabled ultrasound costs just under $7,500 for the Toshiba smartphone, probe and software, as compared to full-size machines that can cost in excess of $100,000. It can also send images wirelessly for consultation or storage.

Mobisante co-founder and CTO David Zar said the development and approval process for the mobile ultrasound imaging system took "a lot longer than expected."

But, he also admitted the extra time and additional protocols imposed by federal regulators allowed them to refine the product and were ultimately positive.

Medical device companies are eager to get new products out and jump into a growing market created by the widespread use of mobile technology. As the pace of innovation picks up, pressure on federal regulators to speed the approval process is likely to increase as well.