FDA

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,...
By Dave Muoio April 12, 2018
The FDA has granted diagnostics company IDx’s De Novo request to market its AI-based software system for the autonomous detection of diabetic retinopathy in adults who have diabetes, called IDx-DR. This decision represents the first AI-based diagnostic system authorized by the FDA for commercialization in the US that can provide a screening decision without the need for clinician interpretation,...
By Bradley Merrill Thompson April 11, 2018
About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. Since the Medical Device Amendments of 1976, a hallmark of FDA’s regulation of medical devices has been the agency’s risk-based approach....
By MobiHealthNews April 6, 2018
In the last quarter the FDA gave the nod to 10 digital health devices. Innovations that aimed to help diabetes management were popular, ranging from the first integrated continuous glucose monitor, which was put out by Dexcom, to Glooko’s insulin titration tool.  Not all FDA news this quarter was good news. In February Roche’s Accu-Check Connect Diabetes Management App was recalled by the FDA for...

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