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.
As medical experts question the efficacy of mammograms in breast cancer screening, a new study shows that computer-aided detection technology (CAD) used during the process does not help spot cancer in patients.
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.
As physicians turn to next-generation devices to monitor breast cancer after surgery, a new study shows that Focal Therapeutics’ 3-D tissue marker device could work alongside current screening methods to improve outcomes for patients.
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.