Medtech

OBJECTIVES: Horizon scanning (HS) is a method used to examine signs of change and may be used in foresight practice. HS methods used for the identification of innovative medicinal products cannot be applied in medical technologies (MedTech) due to differences in development and regulatory processes. The aim of this study is to identify HS and other methodologies used for MedTech foresight in support to healthcare decision-making. METHOD: A mapping review was performed...

BACKGROUND: Juxta-anastomotic stenosis, the most common lesion in arteriovenous fistula, creates a dilemma for optimal balloon size choosing during PTA. OBJECTIVES: To descript the effect of a novel tapered scoring balloon catheter (DK Medtech, Suzhou, China) which has a conical shape with an increasing diameter from the front part of the balloon to the end, and three non-slip elements attached on the surface of the balloon. RESEARCH DESIGN: Case series of 10 patients used this balloon catheter was retrospectively analyzed...

INTRODUCTION: Episiotomy, the deliberate surgical incision on the vaginal orifice during vaginal delivery, requires prompt repairing of the incised tissue. It may be associated with bleeding, infection, dehiscence, dyspareunia, short-term pain, and prolonged hospital stay. The outcome of surgery depends on the suture material and technique to repair the episiotomy. OBJECTIVE: We aim to subjectively assess perineal pain and maternal morbidity following episiotomy repair with Truglyde Fast®  (Healthium Medtech Limited, Bengaluru, India) and Safil Quick® (B...

Epitaxial cathodes in lithium-ion microbatteries are ideal model systems to understand mass and charge transfer across interfaces, plus interphase degradation processes during cycling. Importantly, if grown at <450 °C, they also offer potential for complementary metal-oxide-semiconductor (CMOS) compatible microbatteries for the Internet of Things, flexible electronics, and MedTech devices. Currently, prominent epitaxial cathodes are grown at high temperatures (>600 °C), which imposes both manufacturing and scale-up challenges...

PURPOSE: To evaluate whether stone dust can be obtained from all prevailing stone composition types using the novel pulsed thulium:YAG (p-Tm:YAG), including analysis of stone particle size after lithotripsy. METHODS: Human urinary stones of 7 different compositions were subjected to in vitro lithotripsy using a p-Tm:YAG laser with 270 µm silica core fibers (Thulio® , Dornier MedTech GmbH® , Wessling, Germany). A cumulative energy of 1000 J was applied to each stone using one of three laser settings: 0...

BACKGROUND: Evidence about safety and efficacy of transcatheter aortic valve replacement (TAVR) with the Venus A-Valve system (Venus Medtech, Hangzhou, China) remains limited for patients with pure native aortic regurgitation (PNAR). OBJECTIVES: The single-center study sought to report the one-year clinical outcomes of the Venus A-Valve in the treatment of PNAR. METHODS: This study was a retrospective analysis of prospectively collected data...

A clot in the left atrial appendage (LAA) is an important cause of cardio-embolic stroke. Concomitant occlusion of the LAA during cardiac surgery is found to have reduced postoperative stroke. A study was designed to observe the results of LAA occlusion in 17 patients undergoing coronary artery bypass graft surgery (CABG) and aortic valve replacement (AVR). The LAA was occluded epicardially with a SIRONIX 60-mm linear noncutting stapler (Healthium Medtech Pvt limited, Peenya, Bengaluru). The effectiveness of occlusion was confirmed by trans-esophageal echocardiography and at 2 years of follow-up with trans-thoracic echocardiography...

This work introduces a new music generation system, called AffectMachine-Classical, that is capable of generating affective Classic music in real-time. AffectMachine was designed to be incorporated into biofeedback systems (such as brain-computer-interfaces) to help users become aware of, and ultimately mediate, their own dynamic affective states. That is, this system was developed for music-based MedTech to support real-time emotion self-regulation in users. We provide an overview of the rule-based, probabilistic system architecture, describing the main aspects of the system and how they are novel...

Introduction The meniscus plays a vital role in maintaining knee stability. It acts as a shock absorber and knee filler. The incidence of meniscal tears is estimated to be 60 per 100,000 people. Due to lack of awareness among patients, only 10% of the meniscus tears were treated through partial or total meniscectomy. Recently, the concept of meniscus preservation surgery has emerged to preserve early degeneration of the knee joint. In the current retrospective study, safety and functional outcomes of arthroscopic meniscal repair surgery using Surestitch All inside implants (Sironix Arthroscopy Solutions, Healthium Medtech Limited, Bengalaru, India) were assessed...

The European Union Medical Device Regulations 2017/745 entered into force on May 2021 with changes related to strengthening the clinical evaluation requirements, particularly for high-risk devices. This study investigates how the increased requirements on medical device manufacturers in relation to how clinical evaluation will challenge manufacturers. A quantitative survey study was utilized with responses from 68 senior or functional area subject matter experts working in medical device manufacturing Regulatory or Quality roles...

Artificial intelligence (AI) in healthcare has now begun to make its contributions to real-world patient care with varying degrees of both public and clinical acceptability around it. The heavy investment from governments, industry and academia needed to reach this point has helped to surface different perspectives on AI. As clinical AI applications become a reality, however, there is an increasing need to harness and integrate patient perspectives, which address the distinct needs of different populations, healthcare systems and clinical problems more closely...

BACKGROUND: In many countries worldwide orphan drug regulations are installed but only the United States of America and Japan have an orphan device regulation. For many years surgeons have used off-label or self-assembled medical devices for the prevention, diagnosis or treatment of rare disorders. Four examples are given: an external cardiac pacemaker, a metal brace for clubfoot in newborns, a transcutaneous nerve stimulator and a cystic fibrosis mist tent. CONCLUSION: In this article we argue that we need authorized medical devices as well as medicinal products to prevent, diagnose and treat patients with life-threatening or chronically debilitating disorders with a low prevalence/incidence...

Holistic healthcare precincts are an emerging service model to address the growing health service demands of ageing consumers and an increasing prevalence of chronic diseases. In Australia and similar countries with universal publicly funded Medicare systems, the first point of access to healthcare is provided by general medical practitioners. This case report focuses on successful components of a private, integrated, patient-centred primary care model located in a low socioeconomic population in North Brisbane, Queensland...

Background : Deaths from drug overdose have reached a crisis level, with more than 100,000 reported from April 2020 to April 2021. Novel approaches to address it are urgently needed. Objectives : National Institute on Drug Abuse (NIDA) is leading novel comprehensive efforts to develop safe and effective products that address the needs of the citizens affected by SUD. NIDA aims to support research and development of medical devices intended to monitor, diagnose, or treat substance use disorders. Results : NIDA participates in Blueprint MedTech program is part of the large NIH Blueprint for Neurological Research Initiative...

BACKGROUND: Patient-generated health data (PGHD) collected from innovative wearables are enabling health care to shift to outside clinical settings through remote patient monitoring (RPM) initiatives. However, PGHD are collected continuously under the patient's responsibility in rapidly changing circumstances during the patient's daily life. This poses risks to the quality of PGHD and, in turn, reduces their trustworthiness and fitness for use in clinical practice. OBJECTIVE: Using a sociotechnical health informatics lens, we developed a data quality management (DQM) guideline for PGHD captured from wearable devices used in RPM with the objective of investigating how DQM principles can be applied to ensure that PGHD can reliably inform clinical decision-making in RPM...

INTRODUCTION: Chronic severe aortic regurgitation (AR) has a poor long-term prognosis, especially among old-age patients. Considering their advancing age, the surgical approach of aortic valve replacement may not always be the best alternative modality of treatment in such patients. Therefore, this study's primary goal was to provide an initial summary of the medium- and short-term clinical effectiveness of transcatheter aortic valve replacement (TAVR) guided by accurate multi-detector computed tomography (MDCT) measurements in patients with severe and chronic AR, especially in elderly patients...

PURPOSE: To evaluate visual performance and quality of life after bilateral implantation of two extended depth of focus intraocular lenses (EDOF IOLs). SETTING: Ophthalmology Clinic, Department of Medicine and Science of Ageing, University "G. d'Annunzio" Chieti-Pescara, Italy and Ophthalmic Unit, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Italy. DESIGN: Prospective clinical study. METHODS: 60 eyes of 30 patients with senile cataract where enrolled in this study...

AIMS: This study aims to determine the inactivation kinetics of Geobacillus stearothermophilus and Bacillus atrophaeus biological indicators, treated with vaporized hydrogen peroxide (VH2O2) at an industrial scale. There is an assumption that sterilization processes generate linear kinetic plots of treated biological indicators that are used for informing probability-based decision-making by the MedTech industry for effective sterilization treatments; however, this has not been reported for sterilization using VH2O2...

OBJECTIVE: To quantify the predictors for the ancillary treatments after extracorporeal shock wave lithotripsy (SWL) for renal and upper ureteral stones. MATERIALS AND METHODS: From January 2014 to January 2017, patients undergoing SWL using an electromagnetic lithotripter machine (Compact Delta; Dornier MedTech GmbH, Wessling, Germany) for renal and upper ureteral stones ≤ 20 mm were retrospectively reviewed. All patients underwent CT urography prior to SWL...

BACKGROUND: Despite apparent promise and the availability of numerous examples in the literature, machine learning models are rarely used in practice in ICU units. This mismatch suggests that there are poorly understood barriers preventing uptake, which we aim to identify. METHODS: We begin with a qualitative study with 29 interviews of 40 Intensive Care Unit-, hospital- and MedTech company staff members. As a follow-up to the study, we attempt to quantify some of the technical issues raised...