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.
Amputees are pushing back against a proposal to make Medicare reimbursement for prosthetic limbs and other durable medical equipment stricter, as the feds try to limit unnecessary payments, which amounted to $43 million in 2009.
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.
Google is bringing on Thomas Insel, former director of the National Institute of Mental Health (NIMH), to work for its burgeoning Life Science group and apply the company’s technologies to mental illness.
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.
The U.S. Food and Drug Administration issued in January 2016 a draft guidance outlining important steps medical device manufacturers should take to continually address cybersecurity risks to keep patients safe and better protect the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 The draft guidance details the agency’s recommendations for monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they have entered the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 The draft guidance is part of the FDA’s ongoing efforts to ensure the safety and effectiveness of medical devices, at all stages in their lifecycle, in the face of potential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.
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.
As med tech companies roll out innovative radiation devices to treat breast cancer, medical experts are debating the pros and cons of a new technique that could be less expensive and more convenient than traditional therapy for the disease.
Google has faced some stumbling blocks with Google Glass since launching the product in 2013, deciding earlier this year to stop selling the device to consumers in light of waning sales. However, the company is set to meet increased demand for the product among device makers as a new version of Glass hits the market.
The regulatory territory around e-cigarettes is murky. It’s clouded by scientific issues around the potential and relative harm they cause, as well as governmental concerns around its oversight as a tobacco or a smoking cessation product.