FDA

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 Babyforyou.net.ua 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...
By Jonah Comstock April 3, 2018
Malay Gandhi, best known as the former CEO of Rock Health, has joined Evidation Health as SVP of Business Operations. Evidation Health cofounder and President Christine Lemke announced the hire in a tweet, saying "This makes me so happy. After years of helping @evidation from the outside, @malayhgandhi joins the team full time. Welcome!" Gandhi and Lemke also work together as the founding...
By Dave Muoio April 2, 2018
Smart inhaler company Adherium announced last week that it has received 510(k) clearance for over-the-counter sales of its inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler, called the SmartTouch for Symbicort. Adherium — which is headquartered in San Mateo, California, but holds currently offices in Melbourne, Australia; Auckland, New Zealand; and Amstelveen, The Netherlands...
By Laura Lovett March 28, 2018
Yesterday Dexcom got the nod from the FDA to market their Dexcom G6, an integrated continuous glucose monitoring system (iCGM), making it the first interoperable CGM to get the designation.  “We are a company of firsts, almost everything that has been done in our industry has been done by us first,” Dexcom CEO Kevin Sayer told Babyforyou.net.ua, citing that Dexcom was the first company to have a...

Editor's Pick

steroid-pharm.com/oxandrolon.html

contact us

Узнайте про классный интернет-сайт с информацией про Лечение гастроэнтерологии в Германии у нас