Dave Muoio
Also: MaxQ AI's software to be distributed with Samsung NeuroLogica medical imaging hardware; Boston Children's Hospital's specialists staff 2nd.MD virtual platform.
As the first prescription digital therapeutic approved by the FDA, the treatment will be distributed and supported by a specialist-staffed service center.
Boston-based Syntropy will create a digital platform that allows cancer researchers to share and analyze data from numerous different organizations.
The platform, which allows users to redeem tokens for fitness classes, previously was only available to employers.
The agency's proposal would classify the majority of software released by pharmas as "promotional labeling" that would not require premarket review.
As AI cements its role in healthcare, more and more intelligent software offerings are pursuing 510(k) and De Novo approvals.
Also: FCC certifies second-gen Google Glass Enterprise Edition; Nebula Genomics opens its doors to consumers looking to sell personal data.
Also: L’Oréal unveils UV sensor clip, companion app; Urinary incontinence wearable receives De Novo clearance.
First announced in March, the program allows participants to pay off the device's cost by meeting daily fitness goals.
One collaboration with Jefferson has launched a telehealth fellowship program, with another with USC and Northwestern kickstarts a five-year research study.