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# DarioHealth 510(k) for Apple Lightning-enabled Glucose Meter
- URL: https://www.fdaweb.com/dariohealth-510-k-for-apple-lightning-enabled-glucose-meter/
- Published: 2018-03-26T12:00:00.000Z
- Updated: 2026-09-14T23:55:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141064

FDA has cleared a DarioHealth 510(k) for the company’s Lightning-enabled version of its Dario Blood Glucose Monitoring System which enables the use of the Dario app on iPhone 7, 8 and X smart mobile devices. The clearance permits DarioHealth to offer its glucose meter smartphon connectivity with either a 3.5mm headphone jack or a Lightning connector. The company has been marketing the product in the U.S. for Apple iOS 6.1 platform and higher since gaining FDA clearance 12/2015, and for certain Android-operating phones since 9/2017.