As new mobile health technologies such as wearables and mobile health apps come to market, the US FDA's new guidance is intended to give manufacturers a better idea of what kinds of low-risk wellness products the agency will allow to avoid regulation.
FDA appears to have added more leeway for firms making "wellness" products to avoid active regulation in a newly finalized guidance document, according to industry experts.
FDA's guidance document on "General Wellness: Policy for Low-Risk Devices" was finalized from a January 2015 draft version...
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Roche’s scanners have been integrated with PathAI’s AISight Dx system. The system’s FDA-cleared PCCP allows new components to be validated and integrated without additional FDA clearance. Eric Walk, chief medical officer, hints at future biopharma companion diagnostic collaborations.
A proposed rule from Medicare would impact essential devices for many beneficiaries. AdvaMed says the rule would reduce incentives for companies to innovate and criticizes CMS for not providing the necessary information stakeholders need to fully understand the proposal’s implications.
Just ahead of its 28th meeting, the International Medical Device Regulators Forum has released a summary of the global uptake of its documents.
Political and regulatory pressures make revising the EU’s medtech regulations a tricky balancing act, two renowned medtech experts, Erik Vollebregt and Bassil Akra told Medtech Insight during a recent interview.
Roche’s scanners have been integrated with PathAI’s AISight Dx system. The system’s FDA-cleared PCCP allows new components to be validated and integrated without additional FDA clearance. Eric Walk, chief medical officer, hints at future biopharma companion diagnostic collaborations.
Dutch insulin pump maker ViCentra secured $85m to scale European manufacturing, preparing for the 2026 launch of its thinner, lighter Kaleido 2 pump and push into US market. CEO Tom Arnold said the pump has more than 3,500 users in Europe and expects “tens of thousands” in the next 18 months.
A proposed rule from Medicare would impact essential devices for many beneficiaries. AdvaMed says the rule would reduce incentives for companies to innovate and criticizes CMS for not providing the necessary information stakeholders need to fully understand the proposal’s implications.
