The FDA’s device arm (CDRH) aims to increase use of “real-world” data in decision-making, further engage patients, and strengthen product and manufacturing quality, according to an outline of its strategic priorities for 2016.
With medical testing on the rise, companies are eager to jump on the bandwagon with products geared toward consumers. However, more testing does not always translate into better outcomes for patients, some experts say, and the latest recommendations on breast cancer screening provide a case in point.
Lumos Labs is shelling out $2 million to settle claims from the FTC that it duped consumers about its “brain training” program and apps by convincing them that its games could help stave off serious health conditions or cognitive impairments.
Back in 2013, nonprofit hospital accreditor the Joint Commission set alarm safety for patient monitoring as its safety goal, giving hospitals until January 2016 to set up new policies and procedures for related devices. With the first of the year come and gone, healthcare centers are rolling out new solutions to reduce unnecessary alarms and improve monitoring.
The U.S. National Institutes of Health (NIH) is financing what is expected to be the largest long-term clinical study for an artificial pancreas to regulate the blood sugar levels in Type 1 diabetics to the tune of $12.7 million. This is the biggest chunk it’s yet doled out as part of a program the Agency started in 2014 to promote testing of artificial pancreas systems that’s already backed at least three other research efforts.
Researchers hope to be in proof-of-concept clinical trials within the next five (5) years on brain implants that will create an artificial pathway between the brain and paralyzed limbs. The expectation is that this kind of technology is expected to offer a means to circumvent paralysis that is due to damage to the nervous system that cuts off signals from the brain.
As scientists turn to 3-D printing to build models of human organs, researchers are harnessing the technology to create functional blood vessel structures.
The National Institutes of Health (NIH) has awarded three grants to develop so-called co-robots that will work cooperatively with people to further health and quality of life. This funding for the trio of projects will total about $2.2 million over the next 5 years and stems from the four-year-old interagency National Robotics Initiative.
The deluge of uses for Apple’s ResearchKit and HealthKit development tools seems to be starting in earnest. The latest entrants are a couple of apps aimed at chronic obstructive pulmonary disease (COPD) patients. One, from the non-profit COPD Foundation, hopes to enroll more than 75,000 COPD patients in a lung health research study, while the other is intended to offer the means for patients to better monitor and manage COPD.
As scientists develop next-generation sensors to facilitate patient monitoring, researchers in New Zealand are rolling out a sensor device that can detect estrogen levels without some of the setbacks of current technology.