Tag: Investigational device exemption

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Recent Related Articles to Investigational device exemption

Aethlon Medical to Release First Quarter Financial Results and Host Conference Call on August 9 ...

Added to Collection on: 2021-07-29 17:26:15

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Cancer treatments
Clinical medicine
Medicine
Exosome
Vesicles
Antineoplastic drugs
Breakthrough therapy
Pembrolizumab
Medical device
Investigational device exemption
Food and Drug Administration
Aethlon Medical Inc.

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Reforms needed for FDA's regulation of medical devices - Stat News

Added to Collection on: 2021-12-03 10:09:51

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Health sciences
Health
Food and Drug Administration
Pharmaceutical industry
Medical device
Clinical trial
Investigational device exemption
Bioelectromagnetic medicine

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New FDA Draft Guidance on Use of Digital Health Technologies in Clinical Trials - JD Supra

Added to Collection on: 2021-12-29 16:39:11

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Articles
Health sciences
Clinical research
Health
Pharmaceutical industry
Design of experiments
Food and Drug Administration
Drug safety
Clinical trial
Institutional review board
Human subject research
Investigational device exemption

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FDA Releases Guidance On Digital Health Data Acquisition In Clinical Investigations

Added to Collection on: 2022-03-09 04:28:39

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Pharmaceutical industry
Health sciences
Health
Clinical research
Medical research
Medical statistics
Clinical trials
Clinical data management
Verification and validation
Validation
Clinical endpoint
Investigational device exemption
CyberActa Inc.
John Giantsidis

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FDA seeks input on new medical device cybersecurity guidance | Modern Healthcare

Added to Collection on: 2022-04-07 18:44:24

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Health sciences
Pharmaceutical industry
Food and Drug Administration
Health
Life Sciences
Medical devices
Medical device
Malware
Cyberwarfare
Computer security
Investigational device exemption
Clinical trial

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Endologix reports positive results from percutaneous bypass trial - MassDevice

Added to Collection on: 2022-06-23 16:23:31

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Investigational device exemption
Pharmaceutical industry
IDE
Food and Drug Administration
Health care
Medicine
Health sciences
Endologix

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A Step Forward: FDA Issues Three Draft Guidance Documents As Part of Efforts to ...

Added to Collection on: 2023-09-19 18:04:34

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Food and Drug Administration
Medical device
Federal Food, Drug, and Cosmetic Act
FDA Center for Devices and Radiological Health
Investigational device exemption
Title 21 CFR Part 11

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Microbot Medical is a step closer to an FDA IDE submission - MassDevice

Added to Collection on: 2023-12-07 16:33:55

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Pharmaceutical industry
Investigational device exemption
Clinical trial
Interventional radiology
Good laboratory practice
Microbot Medical

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Nyxoah Announces DREAM U.S. Pivotal Study Meets Primary Endpoints - Yahoo Finance

Added to Collection on: 2024-03-20 06:10:31

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Sleep disorders
Obstructive sleep apnea
Sleep apnea
Apnea–hypopnea index
Hypopnea
Ahi
Transoral robotic surgery
Polysomnography
Forward-looking statement
Apnea
Food and Drug Administration
Investigational device exemption
Nyxoah SA
United States
OSA company
Brussels

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Nyxoah Announces DREAM U.S. Pivotal Study Meets Primary Endpoints | Placera

Added to Collection on: 2024-03-19 20:09:01

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Sleep disorders
Obstructive sleep apnea
Sleep apnea
Forward-looking statement
Apnea–hypopnea index
Transoral robotic surgery
Polysomnography
Hypopnea
Ahi
Food and Drug Administration
Investigational device exemption
Nyxoah SA
United States
Apnea
Brussels

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