Breakthrough Device

Nerve cells affected by Alzheimer's disease

(Photo by Sebastian Kaulitzki/Getty Images)

By  Dave Muoio 03:04 pm April 1, 2021
Those keeping an eye on the digital therapeutics industry over the last several years likely remember the name Dthera Sciences. The startup and its CEO Ed Cox became one of the developing space's many standard bearers around 2018. During that timeframe it landed a Breakthrough Device designation from the FDA for its Alzheimer's symptoms treatment, with Cox chairing a handful of industry...
By  Dave Muoio 02:29 pm October 22, 2020
Searching for outbreaks. The long and sometimes muddled tradition of predicting outbreak hot spots by analyzing search engine activity has continued into the COVID-19 era, with Mayo Clinic researchers publishing new findings that suggest strong correlations between certain keywords and case reports. In reviewing data from Jan. 22 to April 6, "face mask," "Lysol" and "COVID stimulus check" had the...
By  Dave Muoio 01:40 pm December 19, 2019
ECG algorithm picks up Breakthrough Device status. Eko, the maker of tools for monitoring heart function, announced yesterday that a novel ECG-based algorithm for detecting lowered left ventricular ejection fraction has received Breakthrough Device designation from the FDA. By analyzing a 15-second clip of ECG data collected via the company’s other products, the algorithm aims to assist with...
By  Dave Muoio 11:35 am 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  Dave Muoio 03:29 pm 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...