Dive Brief:
- FitBit has its eye on the digital health market, which could complicate things for the fitness tracker company, especially since it is currently involved in a class-action lawsuit alleging its heart-monitoring technology is "wildly inaccurate," Bloomberg Technology reports.
- FitBit's CEO James Park, however, remains focused on clinical technology, has boosted its annual research and development budget to $150 million, and increased its software developer and hardware engineer staff.
- Two of the largest U.S. health insurers use Fitbit devices in diabetes and weight-management programs and the company is developing more advanced sensors that could ultimately monitor blood pressure, blood sugar, and even diagnose diseases, according to Bloomberg.
Dive Insight:
The company is also currently seeking to acquire digital health companies as part of its strategy.
Analysts say the focus on clinical technology will be more expensive to develop and take more time due to FDA regulations. “If they choose to make clinical claims and seek FDA approval, then they’ll probably find that it will cost more and take longer,” Steven Wardell, an analyst at Leerink Partners, told Bloomberg.
Company shares fell more than 40% this year but the heart monitor lawsuit does not seem to dissuade the Fitbit's focus to move towards clinical technology. Fitbit says the case has no merit and plans to vigorously contest it, Reuters reported.
The FDA has not regulated "general wellness devices" to date but said it would move to start regulating technology if Fitbit made claims of diagnoses and treatment of specific conditions.