FDA

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By Jonah Comstock September 17, 2018
Last week, as part of our Focus on Innovation, HIMSS Media ran a poll about the FDA's Pre-Cert program. The program isn't new, but we thought it would be a good moment to take the public pulse on a program that has seen a variety of reactions from inside the industry. Just under 500 readers responded. In general, those opposed the program constituted a vocal minority — just 7.1 percent of...
By Jonah Comstock September 13, 2018
Yesterday, Apple dropped a bombshell on the digital health world, as it is prone to do in its highly-produced launch events. While the announcement included fall detection on the Apple Watch and some improvements to heart rate monitoring, the headline was definitely the announcement that the Apple Watch Series 4 would contain an FDA-cleared ECG sensor. While much of the reaction has been positive...
Apple Watch with ECG feature
By Jonah Comstock September 12, 2018
Well, we finally know what cardiac project Apple was talking with the FDA about two years ago. Apple Chief Operating Officer Jeff Williams announced today at Apple's special event in Cupertino that the company has received FDA clearance for both an atrial fibrillation-detecting algorithm and an ECG that will be built into the company's Series 4 Apple Watch, due to start shipping September 21. ...
By Dave Muoio September 11, 2018
Mountain View, California-based AliveCor announced yesterday that its KardiaK Software Platform has been granted Breakthrough Device designation by the FDA. AliveCor’s software is a neural network trained to read ECG data for elevated levels of blood potassium, a condition known as hyperkalemia that affects the kidneys. Primarily diagnosed through invasive laboratory blood test, KardiaK would...
By Bradley Merrill Thompson September 7, 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. The opinions in this piece are Thompson's and don't necessarily reflect the opinions of Babyforyou.net.ua or HIMSS. FDA’s concept of a...

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By Jonah Comstock August 23, 2018
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. The study was recently published in the Journal of Medical Internet Research. Right now...
By Dave Muoio August 23, 2018
Dthera Sciences, a San Diego-based developer of clinical and consumer digital therapeutics for individuals with neurodegenerative conditions, announced today that its development stage intervention, DTHR-ALZ, has been granted Breakthrough Device designation by the FDA. As laid out in the 21st Century Cures Act, the Breakthrough Devices Program looks to streamline new medical technologies that...
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...
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