October 6, 2020
The FDA has issued an Emergency Use Authorization (EUA) to a clinical decision support (CDS) tool that predicts when an adult patient admitted to the hospital with COVID-19 is at risk of further complications.
Developed by Oakland, California-based diagnostic algorithm developer Dascena, the COViage Hemodynamic Instability and Respiratory Decompensation Prediction System reviews demographic and...
April 24, 2020
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 MobiHealthNews or HIMSS.
Many appreciate that telemedicine...
March 20, 2020
The FDA announced today a new policy that permits expanded use of connected, non-invasive remote vital sign monitors until the end of the COVID-19 public health emergency.
The agency is relaxing its prior guidance so that healthcare teams can monitor their patients outside of the hospital with certain devices that were previously cleared by the FDA, thereby freeing up space for the high volume...
February 7, 2020
The first artificial intelligence-enabled cardiac ultrasound software has received De Novo marketing authorization, the FDA announced today. Developed by Caption Health, the Caption Guidance tool guides medical professionals through a heart disease diagnostic test that normally requires an ultrasound expert.
“Echocardiograms are one of the most widely-used diagnostic tools in the diagnosis and...
January 28, 2020
San Francisco-based EHR developer Practice Fusion has agreed to pay $145 million alongside an admission that it “solicited and received kickbacks from a major opioid company” in exchange for clinical decision support (CDS) alerts promoting unnecessary prescription opioids, according to a release from the US Department of Justice.
In a settlement announced yesterday (and hinted at in an earnings...
October 24, 2019
Healthcare AI company Viz.ai announced that it landed a whopping $50 million in Series B funding this morning. This latest infusion of cash was led by Greenoaks, with participation from Threshold Ventures, CRV, GV and Kleiner Perkins.
The new funding comes a little over a year after the Israeli company raised $21 million from Kleiner Perkins and GV.
WHAT THEY DO
Viz.ai focuses on using AI to...
September 26, 2019
This morning the FDA released two guidance documents relating to the regulation of various digital health software devices.
The first is a draft guidance outlining categories of clinical decision support (CDS) products that would or would not require direct regulatory oversight from the agency. This is an update to a CDS draft guidance released in 2017, with the noteworthy addition of a risk-...
September 26, 2019
Mednition, makers of machine learning-powered solutions for healthcare, announced Wednesday that the company has raised $10 million in a Series A round of funding led by healthcare private equity firm Concord Health Partners. Concord tapped its American Hospital Association Innovation Fund for the financing.
WHAT THEY DO
Burlingame, California-based Mednition was founded in 2014 to help...
November 15, 2018
Every day sees strides across the field of artificial intelligence, and healthcare is just one of the many industries looking to smart automation as a means to reduce burden and improve results. The last year in particular has brought a wealth of new healthcare focused software tools to the forefront, and as such has ignited debate on how these algorithms are being reviewed and regulated by the...
November 8, 2018
Clinical diagnostic and workflow software maker MaxQ AI has received FDA 510(k) marketing clearance for Accipio Ix, an artificial intelligence workflow tool designed to help clinicians prioritize adults patients likely presenting with acute intracranial hemorrhage. The company received notification from the FDA of its decision in late October.
Results generated by the algorithm-based software are...