Blog

Final FDA guidance on regulating Clinical Decision Support (CDS) software as a medical device deviates from draft guidance issued in 2019.  CDS software that is designed to acquire or analyze medical images or signals from diagnostic devices may be subject to regulation as a device; however, software designed for other purposes that meets three other criteria may be exempt.

Researchers at MIT and the University of Rochester Medical Center have developed a device to monitor a Parkinson’s patient at home.

Researchers in Fredericton say they have developed an app to help flag and reduce potentially inappropriate or unnecessary use of medications in nursing homes.

As the U.S. gatekeeper for medical tests, how should the FDA strike a balance between making sure the public has options during a national emergency and making sure those tests actually work?  The Agency’s stumbles during the earliest stages of the COVID-19 pandemic hold some important lessons, according to a report from the inspector general of the Department of Health and Human Services (HHS).

Over the course of the last decade or so, smartphones have slowly morphed into full-fledged medical tools.  Mobile devices are now being used to read diagnostic test results, scan photos taken by their built-in cameras to spot signs of disease and even to take the place of pulse oximeters in measuring blood oxygen levels.

Researchers from Stanford, USC, Georgia Tech, and the University of Tokyo have developed a battery-powered digital health wearable that attaches to the skin and can measure tumor size continuously and in real time, offering hope for advancements in both cancer research and treatment.

Researchers at New York University (NYU) have developed a single test they say can help determine which patients are most likely to see their cancer return after treatment with immunotherapies as well as who may be at risk for severe side effects.

Tattoos made from patches of tiny needles can encode complex medical information directly onto the skin and provide a means to constantly monitor physiological changes to the body.

One of the dangerous things about sports-related concussions is the fact that athletes may not realize they have one, so they do not seek much-needed medical attention.  A new sensor could let them (or their coaches) know, and it would go on their neck, not their head.

A non-toxic, inexpensive process upcycles the little-used music technology into a health-monitoring sensor: An upcycling technique to isolate a compact disc’s thin metallic layer to create flexible biosensors that can monitor body function measurements such as oxygen levels and heart and muscle electrical activity has been developed by a team of researchers led by Binghamton University Assistant Professor Ahyeon Koh. “Everybody can create those kinds of sensors for their users. We want these to become more accessible and affordable, and more easily distributed to the public,” said Koh