April 12, 2018
The FDA has granted diagnostics company IDx’s De Novo request to market its AI-based software system for the autonomous detection of diabetic retinopathy in adults who have diabetes, called IDx-DR.
This decision represents the first AI-based diagnostic system authorized by the FDA for commercialization in the US that can provide a screening decision without the need for clinician interpretation,...
March 29, 2018
San Francisco-based microsensor textile company Siren has announced the first product using its proprietary Neurofabric material. The Siren Diabetic Sock and Foot Monitoring System and its accompanying app monitor wearers’ foot temperature as an early warning sign of inflammation and, subsequently, diabetic foot ulcers.
The company, which was founded in 2015, also announced that it has raised $3....
March 28, 2018
Yesterday Dexcom got the nod from the FDA to market their Dexcom G6, an integrated continuous glucose monitoring system (iCGM), making it the first interoperable CGM to get the designation.
“We are a company of firsts, almost everything that has been done in our industry has been done by us first,” Dexcom CEO Kevin Sayer told MobiHealthNews, citing that Dexcom was the first company to have a...
March 8, 2018
A recent Johns Hopkins study found that prediabetic patients who used the interactive mobile coaching program Sweetch lost weight and increased physical activity.
The study, published in JMIR, found that participant lost a mean 3.5 pounds and significantly improved weekly physical activity over the course of the three-month trial. Participants also saw a decrease in HBa1C or glycated hemoglobin...
March 6, 2018
Samsung Health users will now have access to a new consumer-grade version of WellDoc’s digital diabetes management platform, the two companies announced this morning.
The Diabetes Wellness Program is a 12-week wellness program designed to help Type 2 diabetes patients improve unhealthy behaviors and better manage their condition. The program is available through the Samsung Health version 5.14 or...
February 26, 2018
The FDA has expanded its indication for Medtronic’s Guardian Sensor 3, allowing patients to wear the sensor on their upper arm.
The sensor is part of Medtronic’s MiniMed 670G system, and is currently the only continuous glucose monitor approved by the FDA to control automated insulin delivery via a hybrid closed loop system. Along with the added convenience of the new sensor site, the company...
February 21, 2018
Implantable glucose sensor company Senseonics has launched a remote monitoring app for its users in Europe, the Middle East, and Africa, where its CGM system is distributed by Roche.
The app, called Eversense Now, allows users of the sensor to select up to five friends or family members to view their glucose data, which is updated every five minutes. The feature is available for iOS users at the...
February 14, 2018
Digital diabetes care company Glooko announced today that its Mobile Insulin Dosing System (MIDS) — an app-driven tool that recommends insulin dose adjustments using data collected directly from a patient’s blood glucose meter — has been cleared by the FDA.
The MIDS module allows clinicians to create a customized treatment plan and send it to Type 2 diabetes patients directly through the company’...
February 7, 2018
A new study from Cardiogram suggests that ordinary wearables like Fitbit and Apple watches can detect diabetes and other medical conditions when integrated with Cardiogram’s DeepHeart app.
“Twenty-four percent of people with diabetes, and 88.4 percent with pre-diabetes, don't realize they have it,” Brandon Ballinger, CEO of Cardiogram, told MobiHealthNews in an email. “We don't want to turn...
February 5, 2018
The Juvenile Diabetes Research Foundation (JDRF) and Massachusetts-based Cam Med, a company specializing in microfluidic-based drug delivery technologies, announced a partnership today focused on development of a thin, flexible, patch-based insulin pump for artificial pancreas systems.
"JDRF is excited to partner with Cam Med on improving insulin delivery hardware,” Jaime Giraldo, program...