Two valley health-tech startups win hard-fought FDA approval

Two Silicon Valley companies have received approval from the Food and Drug Administration for heart-tracking apps, marking a hard-fought and costly achievement for these startups and a victory for the fledgling health tech industry.

San Francisco-based AliveCor got the green light last week from regulators for its free mobile app and smartphone case that monitors an individual’s heart health. The technology measures electrical impulses of the heart when the user holds the smartphone encased by the AliveCor Heart Monitor case. The data is stored in the cloud and analyzed by a group of cardiac physicians, and the idea is for users to share it with their doctor or caregiver, and to make better decisions about their own health.

According to Reuters, AliveCor’s newly approved algorithm can detect atrial fibrillation, a form of cardiac arrhythmia that affects about one in four adults over the age of 40.

And Vital Connect, based in Campbell, recently celebrated FDA approval for patches that can measure heart rate, heart health, respiratory rate, skin temperature, stress levels and other vital signs. The data collected by the HealthPatch is sent via wireless bluetooth technology to a smartphone app, and is encrypted and stored in the cloud. The Band-Aid-sized patch is worn against the skin, under clothing.

Valeska Schroeder, Vital Connect vice president of product management, told Reuters that the app puts data in context — depending on whether the user is sleeping, sedentary, exercising moderately or at maximum exertion. If they opt in, physicians get notified when their patients hit or exceed set thresholds.

The FDA approval is notable because it opens the door for both companies to begin selling to doctors and other health care workers, and they are more likely to attract venture funding. Health care has notoriously been a thorny area to try and disrupt because it is so highly regulated. Any app or cloud software that collects and stores patient information may be subject to HIPPA, or Health Insurance Portability and Accountability Act, which requires encryption and high levels of security. And many startups run out of money before they complete the lengthy and laborious FDA approval process.

But from Google and Apple to startups, more companies are tackling health care, and the sector has exploded this year.  Firms invested $632 million into biotech in the second quarter, more than double the amount in the first quarter. and investments in health care service jumped rose $40.5 million. In Silicon Valley, there were 13 healthcare tech company IPOs during the first half of 2014.

Image from AliveCor

 

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