Soon after healthcare workers began warning of personal protective equipment (PPE) shortages, companies and other organizations started claiming their decontamination systems could reprocess used filtering facepiece respirators (FFRs) such as N95s up to 20 times. The FDA began issuing emergency use authorizations (EUAs) for FFR decontamination systems with a range of allowable cycles and major media […]
Duke University
FDA restricts re-use of certain respirators for COVID-19
Certain respirators made in China and respirators with exhalation valves should not be decontaminated for re-use by healthcare workers, the FDA announced today. The agency revised these respirators’ emergency use authorizations (EUAs) to reflect the changes. The particular respirators from China “may vary in their design and performance,” the FDA said, basing its decision on […]
TransMedics touts first U.S. ‘reanimated’ heart transplants
TransMedics (NSDQ:TMDX) announced today that the doctors at two hospitals performed the first U.S. heart transplants using donor hearts that were resuscitated using the company’s organ care system (OCS). The transplants from donation after circulatory death (DCD) took place at Duke University Hospital in Durham, N.C. and Massachusetts General Hospital in Boston. In a DCD procedure, […]
This device can reactivate dead brains: Is it creepy or cool?
Scientists at Yale University have developed a device that can restore circulation and cellular activity in a pig’s brain four hours after death, raising ethical questions about the possibilities of one day applying it to humans. BrainEx is an open-source device originally based on CaVESWave, a system developed by Biomed Innovations of North Carolina to preserve donated organs for […]
Brain tumor ‘monorail’ lands FDA breakthrough device nod
A “tumor monorail” that lures aggressive brain tumor cells to their death in an external container has won “breakthrough device” designation from FDA. The purpose of the device is not to destroy the glioblastoma tumor, but to halt its lethal spread, making the disease more of a condition to manage than a death sentence, according […]
Nanotech, immunotherapy combo vaccinates mouse against cancer
Researchers from Duke University combined an FDA-approved cancer immunotherapy with gold nanostars to boost the cancer-killing abilities of both therapies, according to a study published this week in Scientific Reports. The combination therapy cured two mice and vaccinated one against bladder cancer, the team reported. Get the full story at our sister site, Drug Delivery Business News.
Biopolymer tested as long-acting glucose control therapy
Researchers from Duke University have developed a biopolymer that could provide weeks of glucose control for patients with diabetes – in a single injection. The controlled-release treatment lasted for weeks in primates, according to a study published in Nature Biomedical Engineering. The biomedical engineers suggested that this new, injectable solution could replace daily or weekly insulin shots for […]
Homing system targets drugs to individual neurons
Researchers from Duke University and the Howard Hughes Medical Institute have developed a technique to target and deliver drugs to specific types of neurons in the brain. The team argues that this will enable scientists to more accurately study neurological disease while offering a more targeted treatment method. The current method of treatment for neurological […]
Modification to delivery polymer sidesteps allergic response
Researchers from Duke University have reconfigured the popular drug-delivery polymer, polyethylene glycol, to sidestep dangerous immune responses that have previously halted clinical trials at Duke. The team’s work was published in Nature Biomedical Engineering. Polyethylene glycol, PEG, is a polymer that is found in toothpaste and cosmetics, but is often used in pharmaceuticals. It can be […]
FDA releases priorities for national device evaluation system
The FDA, in association with the Duke Margolis Center for Health Policy, released a report yesterday establishing guidelines for the development of the National Evaluation System for health Technology. The NEST aims to operate as a “cooperative network of partners working to use data, advanced methodologies, and good governance to improve the state of medical device […]
FDA names cardiologist Califf to senior leadership position
(Reuters) — The FDA today named Dr. Robert Califf, a cardiologist and researcher, to oversee its drug, medical device and tobacco policy, in what experts said is a coup for the FDA.
