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Duke University

FDA says to limit mask decontamination to 4 cycles

January 22, 2021 By Nancy Crotti Leave a Comment

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Hospital Care, Regulatory/Compliance, Sterilization / Calibration Tagged With: Advanced Sterilization Products, Battelle, Duke University, FDA, Michigan State University, Sterilucent Inc., Steris Corp., Stryker, Technical Safety Services

FDA restricts re-use of certain respirators for COVID-19

June 8, 2020 By Nancy Crotti

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Respiratory, Sterilization / Calibration Tagged With: Advanced Sterilization Products, Battelle, COVID-19, Duke University, FDA, Sterilucent Inc., Steris Corp., Stryker

TransMedics touts first U.S. ‘reanimated’ heart transplants

December 4, 2019 By Nancy Crotti

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, […]

Filed Under: Business/Financial News, Cardiovascular, Featured, Transplants, Wall Street Beat Tagged With: Duke University, Massachusetts General Hospital, transmedics

This device can reactivate dead brains: Is it creepy or cool?

October 11, 2019 By Nancy Crotti

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 […]

Filed Under: Blog, Featured, Neurological, News Well, Research & Development Tagged With: BioMed Innovations, Duke University, National Institutes of Health, Nature, Stanford University, Yale University

Brain tumor ‘monorail’ lands FDA breakthrough device nod

February 12, 2019 By Nancy Crotti

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 […]

Filed Under: Featured, Implants, Neurological, Oncology, Research & Development Tagged With: Duke University, emoryuniversity, FDA, Georgia Institute of Technology

Nanotech, immunotherapy combo vaccinates mouse against cancer

August 18, 2017 By Sarah Faulkner

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.

Filed Under: Drug-Device Combinations, Oncology, Pharmaceutical, Research & Development Tagged With: Duke University

Biopolymer tested as long-acting glucose control therapy

June 6, 2017 By Sarah Faulkner

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 […]

Filed Under: Diabetes, Drug-Device Combinations, Pharmaceutical, Research & Development Tagged With: Duke University

Homing system targets drugs to individual neurons

April 7, 2017 By Sarah Faulkner

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 […]

Filed Under: Neurological, Pharmaceutical, Research & Development Tagged With: Duke University

Modification to delivery polymer sidesteps allergic response

December 1, 2016 By Sarah Faulkner

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 […]

Filed Under: Drug-Device Combinations, Pharmaceutical, Research & Development Tagged With: Duke University

FDA releases priorities for national device evaluation system

September 21, 2016 By Fink Densford

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 […]

Filed Under: Clinical Trials, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Duke University

FDA names cardiologist Califf to senior leadership position

January 26, 2015 By MassDevice Leave a Comment

FDA names cardiologist 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.

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: Duke University, Personnel Moves

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