Apple eyes FDA approval filing for investigational heart device

  • August 03, 2018

Full details of what Apple is planning have yet to emerge but its disclosures to participants in the study have sketched an outline of its intentions.  The latest communication from Apple gave participants in the ResearchKit study informed consent documents to sign ahead of the initiation of data collection.  A section of the documents disclosed Apple’s plans for the data.  “This study is part of the development of a new investigational device and certain study data will be used for FDA submission to seek approval of the investigational device,” Apple wrote in the document.

The investigational device referred to in the documents is reportedly the study app downloaded by participants in the trial, not a dedicated piece of hardware.  That is in line with previous comments by Apple CEO Tim Cook, who balked at the idea of getting Watch FDA approved but left the door open to regulatory filings covering software related to the device.

In the case of Apple Heart Study, the software is likely to consist of algorithms that interpret data gathered by Watch.  These algorithms will analyze heart rate data from Watch and notify the user if it detects a red flag, such as evidence the wearer suffers from atrial fibrillation or another serious heart condition.  In the trial, participants with potential heart conditions are offered video consultations with the study’s medical team.  The team will then send electrocardiogram patches to some patients.

If Apple files for approval of the app, it will mark a major advance in its long-running flirtation with the healthcare sector.  The tech giant stepped up its interest in the space with the introduction of Watch in 2015 and rollout of its ResearchKit framework.  Talks with the FDA and involvement in its software precertification pilot program followed.  However, Apple has yet to seek FDA clearance of a device.

REFERENCE:  Fierce BioTech; 02 FEB 2018; Nick Paul Taylor

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