FDA is looking for new companies to test out its pre-cert pilot program
The regulator is opening up the program to 510(k) submissions, instead of its initial focus on companies moving through the De Novo regulatory pathway.
FDA considering imposing 10-year limit when manufacturers choose older predicates
FDA is modernizing its 510(k) program and one change it is mulling is placing a limit on how old a predicate device is when manufacturers develop a new product showing substantial equivalence.
Balancing the Role of Physicians and AI [Video]
At the ViVE conference in LA, Smarter Technologies Chief Medical Officer Ruben Amarasingham MD talked with Katie Adams about the company's larger goals for AI: to improve the accuracy of data and make healthcare less burdensome for physicians and clinicians.