CDS

Dascena's COViage system uses demographic and vital-sign data pulled from a COVID-19 patients' EHR to calculate their risk of hemodynamic instability or respiratory failure.

Epstein Becker & Green's Bradley Merrill Thompson describes the agency's current trajectory for regulation of patient-facing and provider-facing telehealth products that incorporate AI.

The temporary policy also extends to some clinical decision support software used in conjuction with these remote monitor devices.

Caption Health's tool instructs non-expert medical staff on how best to produce high-quality diagnostic images in real time.

The Silicon Valley EHR vendor received “sponsorship” payments from unnamed pharmaceutical companies so that the latter’s marketing team could influence the design of CDS features, according to the Department of Justice.

The Series B round was led by Greenoaks with participation from Threshold Ventures, CRV, GV and Kleiner Perkins. 

The new guidances are intended to provide clarity on which products are or are not subject to regulatory enforcement, and to bring the agency’s efforts into compliance with provisions of the 21st Century Cures Act.

Proceeds from the financing will be used to expand the company’s customer care team as Mednition further scales commercial deployment of its machine learning platform.

As AI cements its role in healthcare, more and more intelligent software offerings are pursuing 510(k) and De Novo approvals. 

The AI tool helps clinicians prioritize patients in need of immediate diagnosis, but does not render these decisions on its own.