The medtech said Monday the products will be recalled due to patient health and safety risks, costing the equivalent of about $606 million. The devices use sound abatement foam which can be inhaled and give off harmful chemicals.
The sister company of Google developed the feature to collect data on the motor function of Parkinson's patients in between visits to trial sites. However, the agency questioned the wearable's ability to have a meaningful effect.
Wall Street analysts wrote the recall could drive patients and durable medical equipment providers to ResMed devices, though any benefits right now are "impossible to quantify."
CMS opened up coverage for therapeutic continuous glucose monitors, eliminating a rule that patients must use a blood glucose monitor and require at least four self-monitoring blood glucose tests per day to have devices covered.
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