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Reimagining surgical care for a healthier world

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Video Institution: FDA--Silver Spring MD

Challenges & opportunities associated with the regulation of robotically assisted surgery devices

Presented by Binita S Ashar at the Debate: Robotically Assisted Hernia Repair at the SAGES 2016 Annual Meeting on 3/17/2016 Keyword(s): AHSQC, cardiovascular, CDRH, Center for Devices and Radiological Health, CV, efficiency, FDA, general surgery, innovation, medical devices, mesh, orthopedic surgery, RASD, Robotically-Assisted Surgical Devices, stakeholders, technology

Posted on
05/01/2017
Learning Themes
Hernia
Sources
2016 Annual Meeting
Video Authors
Ashar B
Video Institutions
FDA--Silver Spring MD

Testing duodenoscopes for cleaning & manual high level disinfection

Presented by Shani Haugen at the Session: OR Team – Duodenoscopes, Infections and Reprocessing. What have we learned? at the SAGES 2016 Annual Meeting on 3/19/2016 Keyword(s): disinfection, duodenoscope, EO, ethylene oxide, flex endoscope, FUJIFILM, infection, medical device, Olympus, reprocessing, Spaulding classification

Posted on
04/28/2017
Learning Themes
Flexible Endoscopy, Professional / Economic
Sources
2016 Annual Meeting
Video Authors
Haugen S
Video Institutions
FDA--Silver Spring MD

Update on CRE infections- FDA perspective

Presented by Herbert Lerner at the Session: OR Team – Duodenoscopes, Infections and Reprocessing. What have we learned? at the SAGES 2016 Annual Meeting on 3/19/2016 Keyword(s): 522 studies, CMS, CRE infection, culture, device manufacturers, disinfection, duodenoscope, elevator, EO, ERCP, ethylene oxide, FDA, infection, Joint Commission, MAUDE database, MDR reporting, Olympus, recall, reprocessing, safety

Posted on
04/28/2017
Learning Themes
Flexible Endoscopy, Professional / Economic
Sources
2016 Annual Meeting
Video Authors
Lerner H
Video Institutions
FDA--Silver Spring MD

Why Designing a Trial and Endpoints are Important: Markham C. Luke, M.D., Ph.D.

Device Development Luncheon: From Funding to Freedom to Operate Office of Device Eval–43 sec risk-based classification of medical devices–2:38 SE–3:26 humanitarian device exemptions–4:29 IDE–4:55 importance of clinical studies–6:58 submission types–8: Keyword(s): 510k, CDRH, clinical trials, collaboration, device development, endpoints, engineers, FDA, HDE, IDE, medical devices, Office of Device Evaluation, OUS, Pediatric Medical Device Safety & […]

Posted on
07/20/2010
Video Categories
Device Development Luncheon, Meeting Content, SAGES 2010 Meeting
Learning Themes
Professional / Economic
Sources
2010 Annual Meeting
Presentation Types
Podium Presentation
Video Authors
Luke M
Video Institutions
CDRH--Silver Spring MD, FDA--Silver Spring MD

Our Mission

Innovate, educate and collaborate to improve patient care.

Recently, on SAGES…

Critical View of Safety (CVS) Challenge QR Code

The SAGES Critical View of Safety Challenge – Donate Your Lap Chole Videos!

The Society of American Gastrointestinal and Endoscopic Surgeons is hosting the first Artificial Intelligence Data Challenge conducted by surgeons. The aim of this challenge is to generate a large and diverse dataset of laparoscopic cholecystectomy videos, annotated with respect to the subcomponents of the Critical View of Safety (CVS). Computer scientists from all over the […]

Respuesta de SAGES al Estudio NordICC sobre el beneficio de las colonoscopias de detección

SAGES desea aclarar los resultados del estudio NordICC y colocarlos en contexto de los esfuerzos de varias agencias nacionales para reducir el riesgo de cáncer colorrectal – la segunda causa de muerte por cáncer más frecuente en los Estados Unidos-, mediante la promoción de la detección y tratamiento oportuno de las lesiones.

SAGES Response to NordICC Study Regarding Benefit of Screening Colonoscopies

The NordICC Study recently published in The New England Journal of Medicine and widely reported on by media outlets has raised questions regarding the benefit of screening colonoscopy in lowering the risk of colorectal cancer and cancer-related deaths among otherwise healthy and symptom-free men and women aged 55 to 64. Provocative headlines and commentaries have […]

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