JDRF, ADA redefine Type 1 diabetes framework to encourage early diagnosis, prevention

In an effort aimed at encouraging earlier diagnosis and even potentially prevention for Type 1 diabetes, the JDRF and the American Diabetes Association (ADA) have published a new evaluation of the presymptomatic staging of Type 1 diabetes.  Currently, Type 1 diabetes is typically not diagnosed until the patient in symptomatic–frequently in the emergency room with acute symptoms.

Paraplegic walks by guiding a robotic skeleton with the brain via an EEG system

Robotic exoskeletons to enable paraplegics to walk that are manually controlled have been around for years; arm and hand prosthetics that can be mentally manipulated and enable sensation have also been developed.  Now, researchers have combined some of these capabilities to enable a paraplegic to walk using a robotic exoskeleton controlled by the brain via an electroencephalogram (EEG)-based system.

FDA’s new patient-centric advisory committee to provide additional input on device regulation

The FDA’s device arm (CDRH) announced the launch of the Patient Engagement Advisory Committee to provide additional perspective on topics like patient preference information, risk-benefit determinations and device labeling.  The move is an attempt to ensure that the actual users of devices can influence decision-making, in addition to industry and the medical community.

Study: Cancer-cell mopping implant could stop disease in its tracks

Researchers have long searched for ways to track cancer cells as they proliferate and stop them from spreading. Now, scientists in the U.S. are developing a sponge-like device that can mop up cancer cells as they move through the body, potentially offering an early warning sign to doctors.

FDA outlines cybersecurity recommendations for medical device manufacturers

The U.S. Food and Drug Administration issued in January 2016 a draft guidance outlining important steps medical device manufacturers should take to continually address cybersecurity risks to keep patients safe and better protect the public health.  The draft guidance details the agency’s recommendations for monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they have entered the market.  The draft guidance is part of the FDA’s ongoing efforts to ensure the safety and effectiveness of medical devices, at all stages in their lifecycle, in the face of potential cyber threats.

Researchers successfully transplant insulin-producing cells via new technique

The Diabetes Research Institute (DRI) has had positive results in the first patient in a Phase I/II, pilot trial of a technique it expects could result in a bioengineered mini organ.  This could mean a breakthrough in the race to develop an artificial pancreas that produces insulin in Type 1 diabetic patients.