Closed Research Projects

The project includes an analysis phase on the procedure for in-house manufactured medical devices at three different clinics. The results of existing preliminary research on affected products are to be analyzed in order to achieve a correct procedure according to MDR 2017/745 and MPG 2021. The first project report includes the analysis about the current "In-House" manufacturing process and the procedure to create the technical documentation of the products. This is to be carried out per clinic with reference to details of the products concerned. In the subsequent project phase, an individual concept assessment is carried out for the three clinics based on three products selected in the analysis phase. This includes the classification of individual products, the evaluation of measures already taken for this products, the compilation of the necessary technical documentation, the evaluation of the implemented software development process and the evaluation of the implementation of a quality management system.

Due to the current COVID-19 crisis, our health system is struggling to operate in a stable way and struggling to save many lives. Unfortunately, this fight to keep many patients alive will be a hopeless one if hospitals and cities are already reporting a lack of protective clothing and above all a lack of thousands of vital ventilator systems. A ventilator shortage means some patients are denied lifesaving care. And, as has already happened in many countries, such as in Italy, doctors have to choose which patients get ventilators, and therefore live, and which ones don’t and die. This has led us to look at a solution which our commercialization partner Carl Reiner has been developing inhouse. This design is purely pneumatic, i.e. airpowered and hence, simple and safe to operate with simple existing equipment. It will be simple to manufacture, upgradable with common sensors and display technologies, licensed Europe-wide to manufacturers and its ease of use taught all over Europe.

"Acute dearrangements in the cardio-reno-metabolic axis encompass complex and potentially acutly life-thretening conditions in a large group of patients in the intensive care unit setting. This project focuses on identifying, validating and translating biomarkers for the monitoring of a patients’ clinical course, specifically targeting treatment response as well as metabolites explaining mechanisms of action of used drugs. Comprehensively, in-silico modelling using computational methods is combined with conventional molecular biomarkers. CBmed project 3.3 proved the feasibility of in-silico modelling in acute kidney injury in critically ill patients by targeting patients’ fluid balance. Additionally, the Medical University of Graz under the leadership of Prof. Von Lewniski and Prof. Sourij designed and set up a multicenter, randomized, placebo-controlled trial investigating the impact of Empaglifozin on cardiac function and biomarkers for heart failure in patients with acute myocardial infarction (EMMY trial). The closely linked fields of cardio and renal biomarkers shall provide the opportunity to combine efforts in clinical decision support regarding improvements in monitoring the clinical course, as well as guiding related treatments. This will strengthen understanding of the cardio-renal axis and provide new opportunities to foster treatment efficacy for affected patients. The integration of in-silico modelling and conventional biomarkers into a digital platform for clinical decision support, takes into account CBmed’s strategy to enable cutting-edge technologies for patient care and adds up to digitalization initiatives targeting intensive care medicine with focus on the cardio-reno-metabolic axis."

This project deals with the feasibility of a new Cell-Signaling-Analyzer for studying of cell-biological mechanism using an optical imaging concept.

In this project the project partners will develop and assess a new Next Generation Fluorescence Imaging system used for biomedical basic research and clinical application.

Main focus of the project „QnHT 3.0“ is the medical device development cycle and the corresponding value chain with all its quite complex requirements. Especially young, small, innovative companies often have knowledge deficits in the development of professional project frameworks in the development of a medical device. The course program is designed for medical companies and is divided according to the medical product development cycle and its corresponding value chain management in 7 subgroups of courses which are organised in respective work packages (AP2 - AP7). The project partners - both start-ups and established, larger companies - have from a holistic perspective - significant deficiencies in knowledge for professional product development, business development and successful commercialization of their product ideas in this highly regulated and complex business area. This comprehensive course program enables the project partners, depending on their identified "knowledge gaps", efficient work on their weaknesses by sending key staff to the respective classes. The overall aim of this project is to further increase the already high R & D ratio of over 20% in the human technology enterprises and ensure the arrival of medical innovations in the markets. Qualification within this consortia (intercompany learning) should also open up further opportunities for cooperation. Likewise, the networking between industry and local academia – which has outstanding expertise in the field of medical technology, could lead to long-term cooperation subsequently.

In critically ill patients, volume and/or fluid replacement therapy, if not adequately monitored, may lead to serious conditions such as fluid and electrolyte disorders (e.g. hypokalaemia, hyponatremia) or acute kidney injury (AKI). Although the corresponding parameters (e.g. fluid volume, fluid composition, urine volume) are known, till today no trend analysis of these parameters is performed in order to support therapy or to monitor the disease status of the patient on a near-automated basis. The aim of this project is to develop and to clinically evaluate an application providing decision support for electrolyte and fluid management in critically ill patients. To this end, a semi-closed loop control system will be established by introducing a feedback loop considering patient specific data (e.g. electrolytes in blood, urine volume, body weight) and system specific data (e.g. infusion dose, infusion rate).

The aim of this project is to develop a test environment for defibrillation electrode pads which allows examining the electrodes in accordance with applicable standards and regulations regarding their function and safe usage.

This interdisciplinary research project is concerned with the quantitative determination of myocardial perfusion based on dynamic CT-scans, particularly in terms of physiological determinants and patophysiological changes as well as after administration of drug therapy or cardiovascular surgery.

Proof of Concept of collaborative heart failure care with mobile phone-based telemonitoring.

For the development of a vestibular implant results from high-resolution CT-recordings and corresponding histology of a statistically relevant number of inner ear preparations, an anatomical and electrical computer model of the inner ear will be established. The aimed-for results not only allow the integration of morphology, structure, and anatomical variability with electrical and electrophysiological aspects but also the feasibility of new approaches and technologies for electrostimulation to be explored.

TASER-Waffen beruhen darauf, dass kurze Hochspannungspulse bis zu einer Höhe von 50.000 V abgegeben werden. Diese sollen zu einer elektrischen Durchströmung und damit zu einer Verkrampfung der Skelettmuskulatur führen, um die Gegenwehr oder Flucht einer Person zu unterbinden. Dazu werden entweder aus der Distanz pfeilartige Elektroden abgefeuert (Distanz-Applikation) oder es wird die Waffe direkt in Kontakt mit dem Körper gebracht (Kontakt-Applikation). Die Untersuchungen im Kontakt- und Distanzmode werden an den TASER-Modellen X26 (mit einer Elektroden-Kartusche) und X3 (mit drei verfügbaren Kartuschen) durchgeführt, bei denen die abgefeuerten Pfeil-Elektroden durch Kabeln mit der Waffe verbunden bleiben. Weitere Untersuchungen werden am Modell XREP erfolgen, das eine Kartusche mit batteriebetriebenen Elektroden über größere Entfernungen abfeuern kann. Messtechnisch werden die Abhängigkeit der abgegebenen Impulse von den je nach Elektrodenplatzierung unterschiedlichen Lastwiderständen und die technisch möglichen Durchströmungsvarianten untersucht. Dabei müssen mit großen zeitlichen Auflösungen im ns-Bereich Spannungsimpulse im Bereich von einigen 10.000 V gemessen werden. Ziel der Untersuchungen ist es, die Verteilung des Stromflusses im Körperinneren, insbesonders im Herzen, mit Hilfe anerkannter und im Strahlenschutz bereits international bewährter numerisch-anatomischer Modelle quantitativ zu ermitteln, die durch die Abgabe von Elektroshocks aus TASER-Waffen verursacht werden. Die numerischen Modelle eines Erwachsenen, einer Schwangeren, einer Jugendlichen und eines Herzschrittmacherpatienten erlauben es, die anatomischen Verhältnisse mit einer Auflösung von 2 mm darzustellen und 35 unterschiedliche Körpergewebe nachzubilden. Damit ist es möglich, die Fragestellung ohne direkte Versuche am Menschen abzuklären. In einem weiteren Schritt sollen die Schwellen des Herzkammerflimmerns für die von den TASER-Waffen abgegebenen Impulsformen an numerischen Modellen von Herzmuskelzellen ermittelt werden. Mit Hilfe der so erarbeiteten Grundlagen soll die Risikoabschätzung der Taser-Anwendung vorgenommen werden.

It is the aim of the study to investigate the potential impact of RF electromagnetic fields of transmitters on the sleep quality of nearby residents. In a double- blind crossover field study the effect of an on-site shielding rather than an additional exposure is investigated.

Electric and magnetic fields cause intracorporal current densities. The aim of the project is to investigate the superposition with the example of a power transmission line by numerical simulation.

Das Gesundheitswesen befindet sich im Umbruch. Viele Länder stehen aufgrund einer steigenden Anzahl an älteren Menschen und dem rasanten medizinisch-technischen Fortschritt vor neuen Herausforderungen. Steigende Ausgaben im Gesundheitswesen belasten vor allem immer mehr die öffentlichen Staatshaushalte. Um die notwendigen Gesundheitsleistungen und die damit verbundenen Ausgaben mit den zur Verfügung stehenden knappen finanziellen Ressourcen in Einklang zu bringen, sind Veränderungen im Gesundheitswesen notwendig, um die bestehenden Mängel in der Struktur und Organisation von Gesundheitsleistungen zu verringern.

It is the aim of this study to investigate the potential impact of RF electromagnetic fields of transmitters on the sleep quality of nearby residents. In a double- blind crossover field study the effect of an on-site shielding rather than an additional exposure was investigated.

The aim of this project to get an overview of electrical devices with relevant exposition of the general population regarding electric, magnetic and electromagnetic fields and to develop manageable instructions and rules to verify the compliance with the basic restrictions of the EU reccomendation 1999/519/EG.

Dosimetric assessment of to inhomogeneous electric and magnetic field sources in relation to existing EMF limits. Numerical simulation of inhomogenous exposure conditions and verification by measurement.

Main objectives: Coordination, evaluation and collation of EMF studies Support decision makers in regulation and risk communication Monitor emerging technologies, identify gaps of knowledge Tasks: 1. Dissemination and Management (P. Ravazzani) 2. Scientific evaluation of studies (C. Dasenbrock) 3. Regulations, industry concern and risk communication (D. Papamelithiou) 4. Observation and monitoring emerging technologies (N. Leitgeb) 5. Monitoring secondary aims (T. Samaras)

EIS-EMF is an activity of the Joint Research Center Ispra carried out on behalf of EC-DG SANCO. The main objective is, to devop and implement a EU-wide program of EMF risk communication, and to contribute to the development of an EU official risk communication channel on EMF. The aim is to provide quality information and sound advice for the EC and Member States actions and communication needs; to promote common practices and standards for risk perception monitoring and risk communication at EU level to elaborate tools such as newsletters, fact-sheets, reports etc. for the dissemination of information to stakeholders and EU citizens. EIS-EMF is a partner within the EMF-NET consortium (including also COST Action 281) and developed and operates a web-based information exchange tool among EMF-NET partners and a knowledge-based database to include all relevant scientific data and EC funded project results. Further information can be found at: http://www.jrc.cec.eu.int/EIS-EMF

A new study design has to be developed to investigate the potential impact of RF electromagnetic fields of transmitters on the sleep quality of nearby residents. In a double- blind crossover field study the effect of an on-site shielding rather than an additional exposure has to be investigated.

COST 281 is an European action for co-operation in the field of science and technological research on biological effects of electromagnetic fields from emerging technologies, in particular from mobile communication and information technologies. Aside the active participation of 20 European signatory countries initiatives for co-ordination of and co-operation in EMF research worldwide have already been taken with Japan, Corea and the USA and co-operation has been established with international bodies such as WHO (World Health Organisation), ICNIRP (International Commission on Non-Ionising Radiation Protection) and EBEA (European Bio- Electromagnetics Association).

Initial analytical as well as neurobehavioral findings on manganese retention in rat brains after inhalatory exposure to manganese should be verified and a possible co-influence of magnetic field exposure studied.

Non- specific health symptoms can be very frequently encountered among the general population. Within the group of people suffering from symptoms of unclear origin an increasing number attribute their health problems to electromagnetic fields of internal and/or external electromagnetic field sources. Therefore, these people call themselves "hypersensitive to electricity" or "electrosensitive". The percentage of electrosensitive people varies from country to country. In a common research project the Department of Clinical Engineering of the Institute of Biomedical Engineering together with the Department of Environmental Health at Karolinska Hospital, Stockholm investigated whether three different groups of people could be identified by clinical investigation and biophysical measurements. The respective groups were electrosensitive people with severe symptoms in daily life, people with skin problems attributed to work with video display terminals (VDU) and a healthy control group.

Based on the international comparison of health risks related data the impact of long term high frequency electromagnetic field exposure on health is assessed both for occupationally exposed and for general public, clusters of diseases and/or medical examinations of subgroups are analysed.

Examinations are accomplished and issued certificates for the market permission by active medicine products (and their accessories), which are recognized in the entire European marketing area (to have). Beyond that (did not accredit) the consultant activity on the total area of the biomedical technology becomes.