DarioHealth introduces iPhone 8-friendly blood glucose meter
DarioHealth on Monday announced that the United States Food and Drug Administration has granted pre-market notification (510(k)) clearance for the New York-based company's Lightning-enabled version of the Dario Blood Glucose Monitoring System.
The launch of Apple's smartphones with only a Lightning connector posed a unique challenge to the entire mobile ecosystem. With today's announcement, DarioHealth can now successfully offer to U.S. consumers its proprietary meter with either a 3.5mm headphone jack or Lightning connector.
"We've been working tirelessly to bring forth a solution that would meet the rigorous standards required to achieve the FDA clearance," Erez Raphael, chairman and CEO DarioHealth, said. "We are proud that our organization worked with agility to ensure connectivity to the latest Apple 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. This continues DarioHealth's U.S. market progress, and truly opens the door for wide-scale expansion in this pivotal market."
This news opens a significant U.S. 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 SMDs.
The diabetes company has been marketing the product in the U.S. exclusively for Apple iOS 6.1 platform and higher since the FDA first granted clearance for the Dario Blood Glucose Monitoring System in December 2015, and certain leading Android SMD's including Samsung Galaxy S series, Samsung Galaxy Note series and LG G series, since September 2017. With today's news, DarioHealth plans to expand U.S. sales in the coming weeks.
The launch of Apple's smartphones with only a Lightning connector posed a unique challenge to the entire mobile ecosystem. With today's announcement, DarioHealth can now successfully offer to U.S. consumers its proprietary meter with either a 3.5mm headphone jack or Lightning connector.
"We've been working tirelessly to bring forth a solution that would meet the rigorous standards required to achieve the FDA clearance," Erez Raphael, chairman and CEO DarioHealth, said. "We are proud that our organization worked with agility to ensure connectivity to the latest Apple 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. This continues DarioHealth's U.S. market progress, and truly opens the door for wide-scale expansion in this pivotal market."
This news opens a significant U.S. 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 SMDs.
The diabetes company has been marketing the product in the U.S. exclusively for Apple iOS 6.1 platform and higher since the FDA first granted clearance for the Dario Blood Glucose Monitoring System in December 2015, and certain leading Android SMD's including Samsung Galaxy S series, Samsung Galaxy Note series and LG G series, since September 2017. With today's news, DarioHealth plans to expand U.S. sales in the coming weeks.