The FDA and several industry advocacy groups have reached a tentative agreement regarding the fourth re-authorization of the Medical Device User Fee Agreement (MDUFA), which is slated for delivery to congress in January of 2017. Under the re-authorization, the FDA will collect close to $1 billion in user fees, money that will be allocated to fund several improvements to the FDA’s review process.
Baxter has signed a four-year agreement with Satellite Healthcare, a non-profit organization that provides kidney dialysis and other related services. Baxter’s latest technology in peritoneal dialysis, hemodialysis, and continuous renal replacement therapy will be incorporated into Satellite Healthcare’s service offerings for over 7,000 patients in the U.S.
Scientists from Carnegie Mellon University (CMU) have developed a battery made from melanin, a naturally occurring compound in human skin, eyes and hair, which they say can power a 5 milliWatt device for 18 hours.
The FDA has for the first time cleared a computerized diagnostic device designed specifically to evaluate a patient’s cognitive function immediately following a head injury and a suspected traumatic brain injury (TBI), otherwise known as concussion. While the Immediate Post-Concussion Assessment and Cognitive Testing (imPACT) device cannot conclusively diagnose TBI on its own, or direct a course of treatment, the tool offers point-of-care quantitative evaluation to assist trained healthcare providers in making treatment decisions.
A new handheld device may better equip patients in their decision-making process when choosing an intraocular lens (IOL) implant. The SimVis, developed by Spanish scientists, was tested with cataract surgery candidates, and researchers found patients had a clear preference for certain implants based on their experiences with the device.
SeaSpine has acquired Israeli medtech NLT and its platform of minimally invasive fusion technologies for degenerative spine disease. SeaSpine CEO Keith Valentine remarked that the deal, potentially worth $52.5 million in cash and stock, marks the newly spun-off company’s commitment to innovation through acquisition.
A novel wound dressing for diabetic foot ulcers uses biomaterials science to compensate for the healing limitations experienced by diabetic patients. Researchers from Northwestern University claim the “regenerative bandage” promotes healing four times faster than a traditional bandage, and promotes a more natural healing process, without unnecessary and dangerous side effects.
By combining nanotechnology with bacteria, a team of Canadian scientists has developed a platform for cancer drug delivery it claims is highly precise in targeting cancerous cells. The team’s nanobots are equipped with oxygen sensors that can seek out areas of oxygen depletion in a tumor, which is indicative of active cancer growth.
Apple has filed a patent for a wearable device capable of collecting electrocardiographic (EKG) signals from various points on the body, technology that could be developed into wrist bands, pendants, brooches, or rings. The patent lends credibility to rumors surfacing last week that Apple was working on a stand-alone health-centric device separate from the Apple watch.
Next-generation prosthetics and exoskeletons are using brain-machine interfaces (BMIs) to restore mobility by connecting machines to the same neural circuitry that controlled the limbs of paraplegics prior to injury or stroke. Now, scientists at Duke University have demonstrated research that shows a similar brain-machine interface — a combination of “brain training,” virtual reality, and robotics—can restore partial sensation and movement to limbs paralyzed for years, even decades.