Experience Helped San Diego’s EHS Get First FDA-Approved Wireless Blood Glucose Meter

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 But they quickly realized that the cell phone business was moving so fast that the phone would be outdated by the time they could bring their product to market.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

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Author: Bruce V. Bigelow

In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University. Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.