As researchers zero in on low-cost diagnostics for developing countries, a team of scientists at Rice University nabbed funding from the Bill & Melinda Gates Foundation to develop a miniature plastic microscope for rural communities with a lack of healthcare infrastructure.
The fate of drug/device combination product makers often hinges on a key FDA decision: A review of the product through the rigorous drug pathway rather than the device pathway can scupper a company’s plans.
Unique Device Identification scored a goal in a pair of final rules about electronic health records published by the federal Office of the National Coordinator for Health IT (ONC) and the Centers for Medicare & Medicaid Services (CMS). The development is significant because implementation is proving to be just as complex as the UDI rule itself, for adoption requires buy-in from various agencies besides the FDA (not to mention industry).
Doctors at Massachusetts General Hospital are hoping electrode implants can deliver deep brain stimulation (DBS) that could eventually help treat an array of psychiatric illnesses ranging from post-traumatic stress disorder (PTSD) to schizophrenia.
The U.S. Food and Drug Administration (FDA) is warning the public about eye drop bottles that have loose plastic safety seals or tamper evident rings below the bottle cap that may fall onto the eye when the product is used.
Researchers published in the winter of 2014 on the creation of a biodegradable adhesive patch to repair holes in the heart. Now, they have developed a UV-light-based catheter that can deliver the patch, thereby obviating the need for open-heart surgery, sutures or stoppage of the heart. This latest work, as well as the initial patch development, was published in the journal Science Translational Medicine.
A patent filing reveals that Apple is developing a ring computing device. Worn on the finger, the gizmo is expected to house technology that includes biometric sensors for monitoring cardiac rhythm and perspiration.
As scientists explore the genetic underpinnings of disease to help develop new diagnostics and treatments, an NIH-backed team of researchers is creating the world’s largest database of human genomic variation aimed at clinical use.
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.
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.