Report: Apple in pursuit of FDA approval for iWatch-connected heart app

Apple (NSDQ:AAPL) is taking another major step into the healthcare market as it has begun to collect data it said could be used in pursuit of an FDA approval for an iOS based health application, according to a MobiHealthNews report. Participants in the study recently received prompts to sign informed consent documents that would allow the company to begin collecting data it says “will be used for FDA submission to seek approval of the investigational device,” according to MobiHealthNews. Apple isn’s seeking approval for a new device, though – it’s seeking a nod from the federal watchdog for the application underlying the heart study, and its included algorithms for detecting arrhythmias, according to the report. The study was originally announced last September in partnership with telemedicine company American Well and Stanford University alongside the unveiling of its Series 3 Apple Watch, which includes an improved heart rate monitor it claimed could act as a replacement for traditional heart sensors. The move marks the second swing at the healthcare industry this week for Apple after it announced it is introducing a feature allowing customers to obtain, view and keep medical records on their iPhones on Monday. The post Report: Apple in pursuit of FDA approval for iWatch-connected heart app appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Business/Financial News Cardiovascular Food & Drug Administration (FDA) Patient Monitoring Regulatory/Compliance Apple Source Type: news