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Medfield is planning for CE-certification of Strokefinder MD100 together with Intertek as Notified Body

Medfield has entered into an agreement with Intertek for tests according to standard IEC 60601-1 with applicable substandard guidelines for pre-hospital use as well as CE certification under the Medical Devices Directive, MDD Annex II. The tests will be carried out by Intertek Test House during Q3 2018 and in connection with these tests, ISO 13485-2016 certification audit is also carried out and certification of the technical file for CE certification of the Strokefinder MD100. Medfield and Intertek will now work out detailed plans for the implementation of these activities. CE marking

Strokefinder used in clinical study on patients with head injury

Department of Neurosurgery at Sahlgrenska University Hospital has published a study in the Journal of Neurotrauma. http://online.liebertpub.com/doi/10.1089/neu.2016.4869The publication named “Clinical evaluation of a microwave-based device for detection of traumatic intracranial hemorrhage" describes the enrolment of 20 patients admitted for surgery of chronic subdural hematoma and 20 health volunteers. Microwave examinations with Medfield Strokefinder was compared to the patients’ CT-scan. The result shows that the microwave method has great potential to detect bleedings in this group of

Medfield Diagnostics AB and German MEYTEC GmbH Informationssysteme sign cooperation agreement

Medfield Diagnostics AB, a leader in the development and production of systems for diagnosis of acute stroke, based on new ground breaking microwave technology, and MEYTEC GmbH Informationssysteme, a leader in integration of telemedicine technologies for pre-hospital diagnosis and treatment of acute stroke in mobile and stationary applications, have agreed to join their forces and knowhow to offer healthcare providers efficient integrated pre-hospital solutions to improve diagnosis and treatment of acute stroke.Under the new, non-exclusive cooperation agreement the two companies will

Medfield receives research grant from Boehringer Ingelheim

Boehringer Ingelheim International GmbH and Medfield Diagnostics AB have signed a project agreement to “evaluate and test a novel mobile microwave based diagnosis technology for the detection of stroke in pre-hospital and hospital environments”.Medfield will launch an international multicentre study to generate additional clinical evidence on the ability of the product Strokefinder MD100 to distinguish ischemic stroke from haemorrhagic stroke. Under the agreement, Boehringer Ingelheim (BI) will co-finance this project. Medfield will retain full ownership of the study and make the results

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