Blog

MIT researchers develop noninvasive, fingertip device to count white blood cells in real time

A group of bioengineers have developed a noninvasive, portable device that resembles a finger-worn, pulse oximeter to count white blood cells.  They have three workable prototypes that are being tested with chemotherapy patients to track their immune system in real-time.  The researchers aim to have an initial beta product that it can support via crowdfunding in 2017, with a product on the market potentially in 2019.

Study: Oraya radiation tech reduces need for eye injections in AMD patients

Oraya Therapeutics seeks to reduce the number of eye injections required to treat wet age-related macular degeneration, the leading cause of blindness in the developed world.  It’s CE-marked X-ray device safely delivers radiation to the back of the eye, improving the efficacy of anti-VEGF injectable eye drugs like Genentech’s Lucentis.

Robert Califf aces Senate floor vote and takes the FDA commissioner job

Despite an intense flurry of pushback, the U.S. Senate voted Wednesday to confirm cardiologist Robert Califf as the next Commissioner of the FDA.  The Senate had passed a procedural vote two days prior; however, several Senators had held up the final vote the following day in an effort to push the Agency to be more engaged in its review of opioid analgesics.

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.