Regulation, approval, and access of spinal implants in low-middle-income countries: a narrative review and case study
Expert Rev Med Devices. 2023 Oct 2. doi: 10.1080/17434440.2023.2264767. Online ahead of print.ABSTRACTINTRODUCTION: Spinal implants play a vital role in healthcare delivery, and regulations are necessary to ensure their quality, approval, access, and use. In this article, we examine the current state of regulation and approval procedures for medical devices in low- and middle-income countries (LMICs), emphasizing the situation in Tanzania.AREAS COVERED: We conducted a systematic literature search and interviewed a local spine implant representative to investigate the approval, availability, and access of surgical and spina...
Source: Expert Review of Medical Devices - October 2, 2023 Category: Medical Devices Authors: Chibuikem A Ikwuegbuenyi Laura-Nanna Lohkamp Joel Maruthanal Kassim O Kassim Hamisi Shabani Roger H ärtl Source Type: research
Hydrus microstent for the treatment of primary open-angle glaucoma: overview of its safety and efficacy
This article aims to review the key features of the Hydrus Microstent in terms of design, efficacy, and safety.AREAS COVERED: The present review analyses the main characteristics of the device by evaluating the technical and physical details of its functioning. The evidence that supports a clinical decision summarizes the most influential clinical trials and the most accurate systematic reviews.EXPERT OPINION: The Hydrus device has been extensively studied regarding biocompatibility and outflow potential. The subsequent clinical studies have been well-built and proved that the device effectively reduces intraocular pressur...
Source: Expert Review of Medical Devices - September 27, 2023 Category: Medical Devices Authors: Antonio M Fea Federico Ricardi Rossella Cariola Alessandro Rossi Source Type: research
Bimodular femoral stems in primary total hip arthroplasty
Expert Rev Med Devices. 2023 Sep 27. doi: 10.1080/17434440.2023.2264177. Online ahead of print.ABSTRACTINTRODUCTION: This review critically examines the efficacy of dual-modular stems in primary total hip arthroplasty. Given the variability and non-comparability of certain femoral stem designs and stem-neck couplings, with some even being withdrawn from the market, this review offers an in-depth analysis of predominant implant performances.AREAS COVERED: The paper explores a brief historical summary related to dual-modular stems, including the complications associated with their use, diagnostic tools for evaluation, analys...
Source: Expert Review of Medical Devices - September 27, 2023 Category: Medical Devices Authors: Jan Zajc Samo K Fokter Source Type: research
Role of telemedicine in obstetrics and gynecology: an experience at tertiary care center
CONCLUSION: Non-emergency patients who can be managed medically can be prevented from unnecessary visits to the hospital and managed through teleconsultation which decreases the burden of patient load at the tertiary center.PMID:37753857 | DOI:10.1080/17434440.2023.2264768 (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - September 27, 2023 Category: Medical Devices Authors: Aruna Singh Amit Agarwal Geetika Thakur Sonu Goel Meenu Singh Source Type: research
Hydrus microstent for the treatment of primary open-angle glaucoma: overview of its safety and efficacy
This article aims to review the key features of the Hydrus Microstent in terms of design, efficacy, and safety.AREAS COVERED: The present review analyses the main characteristics of the device by evaluating the technical and physical details of its functioning. The evidence that supports a clinical decision summarizes the most influential clinical trials and the most accurate systematic reviews.EXPERT OPINION: The Hydrus device has been extensively studied regarding biocompatibility and outflow potential. The subsequent clinical studies have been well-built and proved that the device effectively reduces intraocular pressur...
Source: Expert Review of Medical Devices - September 27, 2023 Category: Medical Devices Authors: Antonio M Fea Federico Ricardi Rossella Cariola Alessandro Rossi Source Type: research
Bimodular femoral stems in primary total hip arthroplasty
Expert Rev Med Devices. 2023 Sep 27. doi: 10.1080/17434440.2023.2264177. Online ahead of print.ABSTRACTINTRODUCTION: This review critically examines the efficacy of dual-modular stems in primary total hip arthroplasty. Given the variability and non-comparability of certain femoral stem designs and stem-neck couplings, with some even being withdrawn from the market, this review offers an in-depth analysis of predominant implant performances.AREAS COVERED: The paper explores a brief historical summary related to dual-modular stems, including the complications associated with their use, diagnostic tools for evaluation, analys...
Source: Expert Review of Medical Devices - September 27, 2023 Category: Medical Devices Authors: Jan Zajc Samo K Fokter Source Type: research
Role of telemedicine in obstetrics and gynecology: an experience at tertiary care center
CONCLUSION: Non-emergency patients who can be managed medically can be prevented from unnecessary visits to the hospital and managed through teleconsultation which decreases the burden of patient load at the tertiary center.PMID:37753857 | DOI:10.1080/17434440.2023.2264768 (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - September 27, 2023 Category: Medical Devices Authors: Aruna Singh Amit Agarwal Geetika Thakur Sonu Goel Meenu Singh Source Type: research
