DarioHealth Shares Jump

DarioHealth (DRIO) shares surged in pre-market trading Monday after the digital health company said the US Food and Drug Administration (FDA) has granted pre-market notification (510(k)) clearance for the company’s lightning-enabled version of the acclaimed Dario Blood Glucose Monitoring System which enables the use of the Dario app on iPhone 7, 8 and X smart mobile devices.

“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,” CEO Erez Raphael said in a statement.

Shares rose as much as 32% in pre-market activity.

Consumers in the US market will now be able to receive the same quality user experience with DarioHealth on the latest Apple devices, including the iPhone X.

With Monday’s announcement, DarioHealth can now successfully offer to US consumers its proprietary meter with either a 3.5mm headphone jack or Lightning connector.

This news opens a significant US market opportunity for DarioHealth, as it enables DarioHealth to provide its diabetes management platform and expand the sales of the Dario Blood Glucose Monitoring System to iPhone 7, 8 and X.