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Fitbit looking to produce 510(k) cleared devices


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In an earnings call Fitbit's CEO was asked about whether the company was looking into regulated medical devices, his answer was essentially "yes."

“Look, I think it’s a pretty massive opportunity,” he said. “I think these devices are going to get increasingly more sophisticated over time, but there is obviously a lot of legal and regulatory challenges that we’re going to have to navigate. I think the great thing is that, due to our leadership position, we are very visible in Washington and I think we’re going to have a big seat at the table in driving those discussions, so it’s going to be a pretty big opportunity for us.”

This highlights the competition that pharma and medtech companies are facing from outside their industries. Just like Tesla is an upstart Silicone Valley competitor to the big auto manufacturers we should expect smaller firms to try and compete in healthcare. Whether they can be successful remains to be seen, but consider this from FitBit:

“Our investments in software have resulted in increasing retention of our users over time,” Park said on the call. “We noted that out of 18 million new registered devices users added in 2015, 72 percent were still active users at year end.”

Other stories from MobiHealthNews:

Source: MobiHealthNews

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