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Top FDAer Skeptical Of Wearable Devices, Says Agency Is Working To Improve Standards And Technology

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.

Cracow, Poland - 15 May 2019: Man using Apple Wach Series 4 in silver color to do an ECG or EKG test (Electrocardiography) - Image

The second-highest ranking official at the US Food and Drug Administration says there’s still a lot of skepticism around the use of wearable devices to collect accurate patient data for clinical trials and remote monitoring. However, the agency is passionate about setting standards to help improve the technology.

Novartis AG CEO Vas Narasimhan recently sat down for a chat with Amy Abernethy, principal deputy director at the FDA, about digital health at the 2019 PhRMA Innovation Day...

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