FDA

By Jonah Comstock July 25, 2018
Correction: Thanks to an eagle-eyed reader, this story has been updated to remove the claim that Dip.io is the first FDA-cleared smartphone urine test. We've reached out to Healthy.io for comment on this development and we'll update when we hear more. Tel-Aviv, Israel-based Healthy.io has secured FDA 510(k) clearance for Dip.io, a home-based urinalysis kit that turns a smartphone into a clinical-...
By Jonah Comstock June 22, 2018
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 is committed to advancing novel products that leverage digital technology to improve patient care,” FDA Commissioner Dr. Scott Gottlieb said in a statement. “These technologies allow patients to gain better control over their...
By Jonah Comstock June 20, 2018
The FDA continues to move at a fast pace to develop and, soon, implement its pre-certification program for medical software development. Yesterday the agency released a second draft of its Pre-Cert framework, incorporating some of the comments it received about the April first draft and seeking additional comments on other parts of the framework. The basic goal of the Pre-Cert program, which sets...
By Dave Muoio June 12, 2018
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. Using motion capture technology based on the Microsoft Kinect, the Go engages patients with a range of activities set in displayed 3D environments that promote motor...
By Jonah Comstock June 4, 2018
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. The notice, which will be officially published tomorrow in the Federal Registry, finalizes a guidance that was originally proposed in November 2017. "Today,...
By Bernie Monegain May 30, 2018
The U.S. Food and Drug Administration on Wednesday announced an innovation challenge to address the national opioid epidemic.  Specifically, FDA is looking to the developer community to build digital health technologies, such as medical devices, diagnostic tests and mobile apps to help stem the opioid crisis. The intent is to provide unique approaches to detecting, treating and preventing...
By Jonah Comstock May 16, 2018
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. BioStamp nPoint is a more advanced version of the company's non-FDA cleared BioStampRC. "BiostampRC was primarily developed as an investigational tool, primarily used by academia, as well as by pharmaceutical companies,...
By Mike Miliard April 30, 2018
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. "We’re implementing a new approach to the review of artificial intelligence...
By Jonah Comstock April 26, 2018
This morning, the FDA published its 17-page first draft of a working model for its pre-certification program for software as a medical device (SaMD). Though still preliminary (the agency is asking for comments by the end of May), the publication comes with some long-awaited details about how the program might work. The document lays out five "excellence principles" on which companies applying for...
By Laura Lovett April 18, 2018
Digital health appears to be making its way onto the national stage. Yesterday, FDA Commissioner Scott Gottlieb gave the field a shout-out in his remarks to the US House Subcommittee on Agriculture, Rural Development concerning the Fiscal Year 2019 budget request for the FDA.  “The Budget requests new resources for the FDA to make significant investments in advancing critical areas of science,...