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.
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Software for Google’s Fitbit identifies atrial fibrillation using a photoplethysmography algorithm to detect tiny changes in blood volume with its optical sensor.
The new software for Google’s Fitbit identifies atrial fibrillation using a photoplethysmography algorithm to detect tiny changes in blood volume with its optical sensor.
Are self-care apps and digital health wearables touted as powered by AI actually "intelligent"? Currently, no. However, they could be in the future, if regulators can come up with frameworks flexible enough to keep up with adaptive algorithms and machine learning. This article looks at some of the key regulatory issues facing this fast-growing and exciting consumer health market.