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FDA's Speedy Apple Watch De Novos Raise Questions For Industry

The recent US FDA de novo approvals for heart-rhythm analysis software on Apple's latest Apple Watch, which took about 30 days from submission to a decision that aligned with Apple's high-profile launch event, raised eyebrows in the medtech industry. Some in industry are concerned that the tech giant received preferential treatment over smaller companies, setting a bad precedent. But some say it could be a positive sign for the digital health industry at large.

FRANKFURT,GERMANY-MAY 08,2017:APPLE store and logo. Apple Inc. is an American multinational technology company headquartered in California.
Some are concerned that Apple gained preferential treatment from FDA.

US FDA's unusually fast review of Apple Inc.'s recent software de novo classifications have been hailed as an impressive show of the agency's commitment to digital health. But some stakeholders are concerned Apple was given preferential treatment that could set a troubling precedent.

On Sept. 12, the multinational tech giant unveiled the Apple Watch Series 4, which includes new sensors and software that allow the watch to function as an electrocardiogram (ECG) and uses an atrial fibrillation-detecting algorithm to notify patients if they are at risk for the heart condition

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