FDA
Online patient community PatientsLikeMe, which connects patients with different symptoms and conditions and collects patients' voluntarily submitted data for research, has teamed up with the FDA on a research study that could point the way toward a new channel for patient-generated health data for the agency.
As laid out in the 21st Century Cures Act, the Breakthrough Devices Program looks to streamline new medical technologies that offer improved treatment for serious diseases.
Correction: Thanks to an eagle-eyed reader, this story has been updated to remove the claim that Dip.
At long last, Eversense, the implantable continuous glucose monitoring system from Senseonics, has received FDA clearance to be marketed in the United States.
The FDA continues to move at a fast pace to develop and, soon, implement its pre-certification program for medical software development.
Switzerland-based MindMaze announced today that it has received FDA clearance for the MindMotion Go, a gamified neurorehabilitation therapy platform for medium and light severity impairments able to be deployed in the patient’s home.
As of tomorrow, individual genetic risk tests are officially exempt from requiring 510(k) premarket approval, provided the company offering the test has gone through a one-time premarket review of its testing apparatus and at least one test.
Cambridge, Massachusetts-based sensor maker MC10, known for its flexible and stretchable electronics, has received its first FDA 510(k) clearance for the BioStamp nPoint system.
At AcademyHealth’s 2018 Health Datapalooza on Thursday, the US Food and Drug Administration offered a vote of confidence for artificial intelligence in healthcare, promising more refined strategies for regulation, touting its tech incubator for AI innovation, and announcing a new machine learning partnership with Harvard.