The US Food and Drug Administration (FDA) recently announced its qualification of the Apple Atrial Fibrillation (AFib) History Feature through the Medical Device Development Tools (MDDT) program. The MDDT program is intended...more
In a recent blog post, Fitbit unveiled three new devices in its product line. One of the newly debuted watches, the Sense 2, includes an atrial fibrillation (AFib) detection algorithm that recently received FDA clearance....more
China Passes Major Data Protection Law as Regulatory Scrutiny on Tech Sector Intensifies - A final version of the law has not been published but a previous draft included rules around requiring consent for data protection...more
Manufacturers of activity trackers and smartwatches have been fighting over the “serious” healthcare market for several years. Companies such as Apple (previously discussed here), Fitbit (previously discussed here), and...more
On September 26, 2017, the FDA announced that it has chosen nine tech companies to participate in a pilot program (FDA Pre-Cert) to help tech companies bypass some regulations that have hindered health software and products...more
Fitbit recently announced plans to build sleep apnea diagnostics into its wrist-worn activity tracking devices, stating that it expects do so within a year. If successful, Fitbit may be able to address a market that is...more
At long last, the Food and Drug Administration issued its Nonbinding Recommendations and Guidance regarding "General Wellness: Policy for Low Risk Devices," announcing it will not regulate "low-risk general wellness...more