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Specialty: Medical Devices
Therapy: Vagus Nerve Stimulation Therapy
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Total 15 results found since Jan 2013.
Medtech approvals: FDA releases August 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in August 2015:
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 70
Summary of PMA Originals Under Review
Total Under Review: 57
Total Active: 28
Total On Hold: 29
Summary of PMA Supplements Under Review
Total Under Review: 569
Total Active: 422
Total On Hold: 147
Summary of All PMA Submissions
Originals: 5
Supplements: 90
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 70
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 229.0
FDA Time: 130...
Source: Mass Device - October 23, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Source Type: news
Transcutaneous auricular vagus nerve stimulators: a review of past, present and future devices
This article reviewed the history and classification of taVNS devices.EXPERT OPINION: The correlation between the effectiveness and stimulation parameters from taVNS devices still remains unclear. There is a lack of standard or harmonization among different taVNS devices. Strategies, including further comparative research and establishment of standard, have been recommended in this article to promote the future development of taVNS devices.PMID:34937487 | DOI:10.1080/17434440.2022.2020095
Source: Expert Review of Medical Devices - December 23, 2021 Category: Medical Devices Authors: Lei Wang Yu Wang Yifei Wang Fang Wang Jinling Zhang Shaoyuan Li Mozheng Wu Liang Li Peijing Rong Source Type: research
Transcutaneous auricular vagus nerve stimulators: a review of past, present, and future devices
This article reviewed the history and classification of taVNS devices.EXPERT OPINION: The correlation between the effectiveness and stimulation parameters from taVNS devices still remains unclear. There is a lack of standard or harmonization among different taVNS devices. Strategies, including further comparative research and establishment of standard, have been recommended in this article to promote the future development of taVNS devices.PMID:34937487 | DOI:10.1080/17434440.2022.2020095
Source: Expert Review of Medical Devices - December 23, 2021 Category: Medical Devices Authors: Lei Wang Yu Wang Yifei Wang Fang Wang Jinling Zhang Shaoyuan Li Mozheng Wu Liang Li Peijing Rong Source Type: research
Recent advances in devices for vagus nerve stimulation.
Authors: Mertens A, Raedt R, Gadeyne S, Carrette E, Boon P, Vonck K
Abstract
INTRODUCTION: Vagus nerve stimulation (VNS) has become a valuable treatment option for refractory epilepsy and depression. To improve clinical efficacy and minimize side effects, novel device technology for vagus nerve stimulation is under development and investigation. Areas covered: For epilepsy, the AspireSR® and SenTiva™ VNS therapy systems are the 2 most recently developed VNS devices. These novel devices have implemented a closed-loop approach and contain a cardiac based seizure detection algorithm. The mechanism of action of VNS ...
Source: Expert Review of Medical Devices - August 4, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research
