FDA chief Dr. Scott Gottlieb announced today the next steps for his agency’s digital health pre-certification pilot program. “Digital tools are rapidly evolving, and to keep pace with this promising innovation, the FDA must modernize its approach to regulation,” he said in a statement. The program, which launched in October of 2017, was designed to […]
Digital Health
CES 2019: Medical technologies you need to know
Mobile health devices and wearables are increasingly playing a prominent role at the annual CES show in Las Vegas, with 505 digital health and 620 wearables exhibitors at this year’s show. Health and medical devices touted at CES 2019 – Jan. 8–11 – were meant to improve everything from posture to sleep analysis. Time will tell […]
Medtronic, IBM Watson debut hypoglycemia prediction feature for diabetes app
Medtronic (NYSE:MDT) and IBM Watson Health today launched a new feature for its Sugar.IQ personal diabetes assistant app that can predict the likelihood of a user experiencing a low glucose event within a four-hour window. The feature, called IQcast, uses AI tech from IBM and becomes more accurate as the low blood sugar event draws nearer, according to […]
DarioHealth inks U.S. distro deal for digital glucose meter
DarioHealth (NSDQ:DRIO) said today that it inked a deal with healthcare products provider Better Living Now for the distribution of its blood glucose monitoring system and the DarioEngage digital health program. According to the terms of the deal, BLN plans to buy DarioHealth’s smart glucose meter and test strips to distribute to its customers. The agreement […]
Researchers design ingestible sensor for controlled drug release
Researchers from MIT, Brigham & Women’s Hospital and Draper have developed a Bluetooth-controlled ingestible capsule that can sense the temperature of its environment and reside in the stomach for at least a month. The device, which was tested in an animal study and composed of 3D-printed parts, is powered by a small silver oxide battery and relays data to a […]
Nemaura prices $2.5m offering to support launch of wearable glucose monitor
Nemaura Medical (NSDQ:NMRD) said this week that it priced a public offering of the company’s common stock and warrants, hoping to reel in $2.5 million in proceeds. The offering is slated to close today. Nemaura plans to use the offering’s proceeds to support the launch of its wearable glucose monitor in Europe, as well as the development of […]
Tidepool raises $6m to develop automated insulin delivery app
Tidepool said this week that it raised $6 million from JDRF and the Leona M. & Harry B. Helmsley Charitable Trust to support the development of Tidepool Loop – a hybrid, closed-loop automated insulin delivery app. Tidepool, a non-profit diabetes data management group, is working to create an FDA-regulated app that is compatible with multiple insulin […]
Entrepreneur insights: Q&A with Sana Health’s CEO and founder
Sana Health’s Richard Hanbury chats about medtech investors, the opioid crisis and the importance of data. Heather Thompson, senior editor Speaking with Richard Hanbury, you get a sense that he knows exactly why and how his approach to pain management is getting noticed. Hanbury is the force behind Sana, and his life’s story is the foundation […]
Nemaura develops predictive algorithms for continuous glucose monitor
Nemaura Medical (NSDQ:NMRD) said today that it successfully developed predictive algorithms to support alarm functions in its sugarBeat continuous glucose monitoring system. The England-based company touted that its device’s alarm functionality can predict a user’s glucose level five minutes in advance with 98% accuracy, 10 minutes in advance with 95% accuracy and 15 minutes in advance with 90% accuracy. […]
Senseonics reports mixed Q3 results
Shares in Senseonics (NYSE:SENS) fell today after the medical device maker missed EPS expectations but met sales estimates on Wall Street with its third quarter financial results. The Germantown, Md.-based company posted a net loss of -$31.9 million on sales of $5.2 million for the 3 months ended Sept. 30. Quarterly net losses were up 83% on sales […]
Insulet inks deal with Samsung to develop smartphone-controlled Omnipod
Insulet (NSDQ:PODD) said this week that it inked a deal with Samsung to develop an Omnipod insulin delivery system that would allow users to control their insulin pump therapy with a Galaxy smartphone. If approved, the system would be the first of its kind, according to the Billerica, Mass.-based company. Get the full story at our […]