DarioHealth granted 510(k) clearance for Apple Lightning-compatible glucose monitor

By Dave Muoio
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Israel-based DarioHealth has been granted 510(k) clearance for a version of its Blood Glucose Monitoring System that, alongside the Dario app, is compatible with iPhone 7, 8, and X, according to a statement from the company.

“We’ve been working tirelessly to bring forth a solution that would meet the rigorous standards required to achieve the FDA clearance,” DarioHealth CEO and Chairman Erez Raphael said in a statement. “This is a big breakthrough to receive the FDA’s marketing clearance for the Dario product on iPhone 7, 8, and X, and allows many of our past users who upgraded to these new iPhones to renew their Dario experience. This continues DarioHealth’s US market progress, and truly opens the door for wide-scale expansion in this pivotal market.

Dario’s system consists of a pocket-sized device that includes a glucose meter, disposable test strip cartridge, a lancing device, and a companion smartphone app.

DarioHealth initially received FDA clearance for the digital diabetes monitoring system in December 2015, but due to the hardware’s reliance on a 3.5mm headphone jack, the company was among the many health device companies left out in the cold when Apple announced its controversial decision to remove the jack in favor of the Apple-specific Lightning connector alone.

"This [3.5mm jack removal] news comes as no surprise to us, and we've been working on a solution for quite some time now," Raphael said in 2016. "Our team's agility to navigate the complex mobile ecosystem showcases DarioHealth's versatility and passion to be at the forefront of cutting-edge technology in general, and the diabetes healthcare market specifically."

DarioHealth’s Lightning-compatible system received a CE Mark in October, and within the US has been available on certain Android smartphones, such as the Samsung Galaxy S series, the Samsung Galaxy Note series, and the LG G series, since September. With the most recent clearance, the company said that it intends to expand its US sales within the coming weeks.

The move toward Lightning compatibility and expanded US sales efforts were among several leading topics discussed by Raphael on an earnings call last November. His additional comments included points on DarioHealth’s German market launch the company’s new B2B platform, Dario Engage.