Results 41 to 50 of about 333,056 (304)

Number of digital therapeutics extracted from openFDA device databases as of November 1, 2021, categorized by medical specialty (as reported by the FDA) and regulatory approval pathways.

, 2022
Number of digital therapeutics extracted from openFDA device databases as of November 1, 2021, categorized by medical specialty (as reported by the FDA) and regulatory approval pathways.
Brenda Y. Miao (11964970), Michelle Wang (242126), Atul J. Butte (8032262), Douglas Arneson (3446480)   +3 more
core   +1 more source

Therapeutic Apheresis for Intravenous Methylprednisolone‐Refractory Neuromyelitis Optica Spectrum Disorder: Clinical and Radiological Outcomes in a Single‐Center Case Series

Therapeutic Apheresis and Dialysis, EarlyView.
ABSTRACT Background Neuromyelitis optica spectrum disorder (NMOSD) is a relapsing autoimmune disease of the central nervous system. High‐dose intravenous methylprednisolone (IVMP) is the standard first‐line therapy for acute attacks, although some patients remain refractory.
Wataru Horiguchi, Daisuke Katagiri, Takeyuki Watadani, Shunichi Matsuda, Hiroshi Kaneko, Noritoshi Arai   +5 more
wiley   +1 more source

Design rationale for the regulatory approval of medical devices [PDF]

, 2012
Design rationale is a methodology aimed at capturing and representing design decisions according to a designated structure. Additionally, these design decisions and their underlying arguments can be made available for examination at a later date.
Sagoo, Jeevan
core  

Davids versus Goliaths: Pharma and academia threats to individual scientists and clinicians

The Journal of Scientific Practice and Integrity, 2022
# Background We previously described experiences of clinicians who published adverse drug reaction reports. We now report on threats and intimidations leveled against clinicians and scientists who received publicly documented threats after communicating
Charles L. Bennett, Nancy Olivieri, Shamia Hoque, David Aboulafia, Anne Ventrone, Courtney Lubaczewski, Betty Dong, Benjamin Schooley, Bartlett J. Witherspoon, Paul S. Ray, William J. Hrushesky, John Restaino, Henrik S. Thomsen, Dennis Mangano, Christina Mora-Mangano, June M. McKoy, Martin Schoen, Kevin Knopf, Linda Martin, Steven Rosen   +19 more
doaj   +1 more source

Effects of the Fluid Replacement Method During Online Hemodiafiltration on the Solute Removal Performance and Biocompatibility Using the Asymmetric Cellulose Triacetate Membrane

Therapeutic Apheresis and Dialysis, EarlyView.
ABSTRACT Introduction Pre‐dilution online hemodiafiltration (Pre‐HDF) is predominantly used in Japan, whereas post‐dilution online HDF (Post‐HDF) is more common in Europe. An asymmetric cellulose triacetate (ATA) membrane may improve biocompatibility.
Kenji Sakurai, Yoshitaka Kurihara, Fumi Yamauchi, Hiromi Hosoya, Takeshi Saito   +4 more
wiley   +1 more source

Value Creation in Uncertain Regulation: Investor Management of FDA Medical Device Approval

, 2022
This study investigates whether there are firm and device-specific characteristics that affect the magnitude of returns to public investors around FDA medical device approval.
Lewandrowski, Sophia
core  

Bivariable and multivariable multinomial logistic regression for factors associated with voting to abstain or voting “not in favor” during the final device approval recommendation vote.

, 2022
Bivariable and multivariable multinomial logistic regression for factors associated with voting to abstain or voting “not in favor” during the final device approval recommendation vote.
Emir Veledar (3385862), Arianna F. Yanes (12936686), Sarah A. Ibrahim (11255826), Kelly A. Reynolds (3006534), Bianca Y. Kang (12695093), Murad Alam (3525044), Noor Anvery (12936689), Daniel I. Schlessinger (12936683), Amanda Maisel-Campbell (12936680), Emily Poon (3525038)   +9 more
core   +1 more source

Seeking a common human factors language for the development and testing of injection devices

Drug Delivery
Injection devices include drug–device combination products incorporating a needle for subcutaneous medication delivery. Often utilized by patients and caregivers, it is important for injection device user interface (UI) design to be intuitive to use ...
Megan O. Conrad, Molly E. Laird, Mary Beth Privitera, Melissa R. Lemke, Molly Follette Story   +4 more
doaj   +1 more source

Pivotal trials of orthopedic surgical devices in the United States: predominance of two-arm non-inferiority designs

Trials, 2017
Background The United States Food and Drug Administration (FDA) reviews class III orthopedic devices submitted for premarket approval with pivotal clinical trials.
S. Raymond Golish
doaj   +1 more source

Trigeminal nerve stimulation: a recently approved treatment approach in attention deficit hyperactivity disorder

The Egyptian Journal of Neurology, Psychiatry and Neurosurgery, 2021
Attention-deficit hyperactivity disorder (ADHD) with its high prevalence is a growing area of concern and research, whereas exact underlying pathophysiology remains unknown. Behavioral therapy and multiple medications include methylphenidate, atomoxetine,
Mazlum Çöpür, Sidar Çöpür
doaj   +1 more source