Experience Helped San Diego’s EHS Get First FDA-Approved Wireless Blood Glucose Meter
(Page 2 of 3)
one of his first startups, San Diego-based Infomedix Communications, in 1999.
“It took about nine months to get it through the FDA,” Ahern says. “He had done about 100 devices before that.”
Beyond the device itself, Entra Health also offers a comprehensive, Web-based diabetes management platform that automates the process of plotting individual blood-glucose levels, giving patients more direct control of their own care. Because doctors, relatives, and caregivers also can access the online data, Entra Health says it helps clinicians stay up-to-date on patients and enhances their communications.
The startup’s rapid progress reflects some decisions that proved to be fortuitous.
Strobridge said the founders initially envisioned a device that combined a cell phone and blood glucose monitor. But they quickly realized that the cell phone business was moving so fast that the phone would be outdated by the time they could bring their product to market.
So they decided instead to develop a blood glucose meter that could plug into a mobile phone. Patients insert a test strip with a 0.3 microliter sample of their blood into the meter, which uses Bluetooth technology to transmit test results to the phone. The device then transmits the data to a Web portal at myglucohealth.net.
As it turns out, the company had a much easier time winning FDA approval because regulators only had to validate that the meter was the same as existing technology.If the company had integrated the meter in the phone, Strobridge says regulators would have gotten bogged down in the process of evaluating the entire phone.
Deciding to first apply for … Next Page »