DarioHealth Receives 510(k) Clearance for Apple Lightning-Compatible Blood Glucose Monitor
Diabetes management startup DarioHealth announced yesterday that the company had received 510(k) market clearance for a new version of its Blood Glucose Monitoring System and app that is designed to be compatible with newer iPhones. 510(k) clearance is a type of premarket approval that medical device manufacturers must receive before marketing their product, and it attests that the product is “substantially equivalent” to another product that has already been cleared by the FDA- in this case, to previous versions of DarioHealth’s Blood Glucose Monitoring System.
“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.
Although the device had already received FDA clearance for traditional smartphones, the device was not previously compatible with Apple’s new Lightning smartphones, which replaced the traditional headphone jack with Apple’s proprietary Lightning connector.
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.
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.