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The first is a draft guidance outlining categories of clinical decision support (CDS) products that would or would not require direct regulatory oversight from the agency. This is an update to a CDS draft guidance released in 2017, with the noteworthy addition of a risk-...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...
February 14, 2019
New research published in the BMJ this week has shown that access to online decision support and feedback for UK GPs led to a decrease in the number of unnecessary antibiotic prescriptions for respiratory illness by 12 percent.
A team from the School of Population Health and Environmental Sciences at King’s College London carried out the year-long trial, funded by National Institute for Health...
January 16, 2019
This morning healthcare data platform Innovaccer announced that it has raised an additional $10 million in funding, boosting its Series B funding round up to $35 million.
The additional funding was led by Microsoft’s venture fund M12, with participation from Westbridge Capital and Lightspeed. In May the company announced the first $25 million of its Series B funding, which was led by Westbridge...
October 10, 2018
NASA is turning its attention to digital clinical support tools to treat astronauts that get sick or injured while in outer space. This morning the news broke that NASA will be piloting Wolters Kluwer’s UpToDate tool, which gives users evidence-based clinical decision support resources, on the International Space Station. According to the company, this marks the first time a clinical decision...
MIT's CSAIL institute is located in the Stata Center. Credit: Google Maps
August 20, 2018
ReMix, a new technology in the works at MIT's Computer Science and Artificial Intelligence Laboratory, seeks to make progress toward a new paradigm of treatment – one that's less reliant on endoscopy and surgery, but instead relies on sensors and what scientists call an "in-body GPS" to help make diagnoses and guide drug administration.
The goal, researchers said, is a new approach to patient...
July 18, 2018
Healthcare AI company Viz.ai announced today that it has raised $21 million in Series A funding. The investment was led by Kleiner Perkins, with additional participation from GV (formerly Google Ventures).
Viz.ai’s primary product is Contact, the first FDA-cleared clinical decision support (CDS) tool that analyzes CT results and highlights cases that may have experienced a stroke for review by a...
July 11, 2018
Kibbutz Shefayim, Israel-based deep learning startup Zebra Medical Vision announced that it has received FDA 510(k) clearance for an algorithm that helps physicians quantify a patient’s coronary artery calcification.
From a ECG-gated computed tomography (CT) scan, the Coronary Calcium Scoring algorithm automatically calculates a calcification rating equivalent to those derived using the Agatston...
June 18, 2018
To all of the people who work with machine learning and neural networks healthcare technologies, but can’t describe exactly how the gears are turning — don’t worry, you’re not alone.
In a sold-out discussion hosted at Optum’s Boston office and organized by the Design Museum Foundation, Sanji Fernando, vice president and head of OptumLabs’ Center for Applied Data Science, explained how the ongoing...
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....