On the heels of FDA clearance for the firm's ingestible sensor technology, Proteus Digital Health Chief Medical Officer George Savage talks to “The Gray Sheet.”
Wireless health holds the promise of better patient monitoring, compliance with treatment regimes and medication adherence. Now the field is taking a step forward thanks to a recent FDA OK that paves the way for a new category of digital pills designed to tell consumers and their caregivers when they’ve skipped a medication dose.
On July 30, Proteus Digital Health announced FDA had granted de novo clearance for the firm’s ingestible sensor technology. The...
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Israeli device firm Fairtility recently obtained US FDA clearance for the CHLOE platform, which uses AI to make embryo assessments performed as part of in vitro fertilization more transparent, efficient and reliable.
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.
