Financial ImpactPhilips will need to conduct follow-up testing on 15 million devices and further site inspections, indicating significant costs and delays before re-entering the US market.
Product Efficacy ConcernsWeight loss drugs are not an obstructive sleep apnea cure, with only a small percentage of patients achieving a 'normal' AHI, which might not significantly reduce CPAP therapy usage and could impact mask revenue.
Regulatory ChallengesPhilips has agreed on the final terms of the CPAP consent decree, which includes a permanent injunction on new CPAP sales, reflecting FDA's view of Philips having multiple violations.