AliveCor, the leader in FDA-cleared personal electrocardiogram (EKG) technology, has announced FDA clearance of KardiaBand in the US, allowing Apple Watch users to discreetly capture their EKG anytime, anywhere in order to quickly detect normal sinus heart rhythms and atrial fibrillation (AFib), the most common heart arrhythmia and a leading cause of stroke. The first FDA-cleared medical device accessory for Apple Watch, KardiaBand can record an EKG in 30 seconds with just a touch of its integrated sensor. AliveCor is also introducing SmartRhythm, a new feature within the Kardia app for Apple Watch. SmartRhythm uses artificial intelligence in concert with inputs from Apple Watch’s heart rate and activity sensors to continuously evaluate the correlation between heart activity and physical activity. When SmartRhythm detects that heart rate and activity are out of sync, the device notifies users to capture an EKG with KardiaBand, or with KardiaMobile, AliveCor’s popular, portable EKG reader. AliveCor is a privately-held company headquartered in Mountain View, CA.
FDA clears first medical device accessory for Apple Watch. [news release]. Mountain View, CA: AliveCor, Inc. November 30, 2017. http://www.pharmalive.com/fda-clears-first-medical-device-accessory-for-apple-watch/. Accessed November 30, 2017.
This Week's Must Reads
Must Reads in FDA Actions
FDA Approves Firdapse for Rare Autoimmune Disorder, FDA news release; 2018 Nov 28
FDA Approves Ajovy for Migraine in Adults, Teva Pharmaceutical news release; 2018 Sep 14
FDA Approves Tiglutik for Treatment of ALS, ITF Pharma news release; 2018 Sep 6
FDA Approves Diacomit for Treatment of Seizures, Biocodex news release; 2018 Aug 23
FDA Approves Drug for Rare Peripheral Nerve Disease, FDA Web site; 2018 Aug 10