FDA: Apple De Novo Approvals Signal Innovation To Digital Health Firms
The latest Apple Watch includes an electrocardiogram that has received de novo clearance from US FDA to detect irregular heart rhythms. The approval, say two top US FDA regulators, is a signal to the digital health industry that the agency is trying to help them innovate.
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US regulators have cleared a suite of cloud-based artificial intelligence software intended to be used with Eko’s digital stethoscopes to detect certain heart problems. The company says the AI algorithms are the first of its kind to be cleared by the US FDA.
Amy Abernethy, the principal deputy commissioner at the US FDA, told attendees at a 25 July medical conference that she's somewhat skeptical about using wearable technologies for clinical needs because they still haven’t proven their accuracy. However, she says the device center is working hard to develop new standards for such products and is looking for funding to develop them.
Artificial intelligence (AI) is quickly becoming part of our day-to-day routines, and healthcare is one area in which AI stands to make the biggest impact. But where is the technology headed? Leading figures from the medtech industry gathered at the Medical Design & Manufacturing East (MD&M East) meeting held in New York City to discuss.