Future LUMOback posture devices to seek FDA clearance

By Brian Dolan
05:00 am

gh98g98fewIn recent weeks LUMOback, the startup developing a wearable sensor and companion app that help users become more aware of their posture, raised more than $100,000 on crowdfunding site, Kickstarter. As we noted in a previous post, LUMOback managed to raise funds on the site even though it has rejected many other health and wellness-related projects in recent months. More recently Shiv Gaglani at Medgadget interviewed LUMOback co-founder Monisha Perkash who revealed some of the company’s future plans and strategy.

Perkash told Medgadget that LUMOback decided to “kickstart” its device to raise funds to pay for the production of its first run of devices. As we reported in April, LUMOback has already received more than $1 million in funding this year so the crowdfunding move is perhaps somewhat surprising. Still, the company now has more than 1,000 backers who have already paid up for their sensor, so the move was a smart one.

Most interesting of all was Perkash’s take on the device’s regulatory situation: Since the FDA specifically wrote that posture devices fall outside of the its regulatory purview in its mobile medical apps draft guidance last year, she said the initial device will not be submitted for FDA clearance. However, LUMOback does plan to develop and market devices that would require FDA clearance and a CE Mark in the future.

The investors that backed LUMOback's initial round of funding included Innovation Endeavors, Morado Venture Partners and Russell Siegelman --a former partner at Kleiner Perkins Caufield Byers

Be sure to read the Medgadget interview here.


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