Übersetzung für "Investigational device" in Deutsch

If the sponsor is not the natural or legal person responsible for the manufacture of the investigational device, that obligation may be fulfilled by that person on behalf of the sponsor.

Berlin, Germany and Nevada, USA, May 21, 2015 - MagForce USA, Inc., a majority owned subsidiary of MagForce AG (Frankfurt, Entry Standard, XETRA: MF6, ISIN: DE000A0HGQF5), a leading medical device company in the field of nanomedicine focused on oncology, announced today it has filed an Investigational Device Exemption (IDE) with the USA Food and Drug Administration (FDA).

The U.S. Food and Drug Administration (FDA) has just granted our US subsidiary MagForce USA, Inc. the Investigational Device Exemption (IDE) to conduct a clinical trial with NanoTherm(R) therapy as focal ablation treatment for intermediate risk prostate cancer.

Following the Investigational Device Exemption (IDE) approval by the US Food and Drug Administration (FDA) announced earlier this year, recruitment in the trial is underway at the two trial sites, the CHRISTUS Santa Rosa Hospital - Medical Center and the University of Washington.

A Phase II Clinical Study was conducted with 378 subjects enrolled in 15 study centers throughout the U.S. under an Investigational Device Exemption (IDE) to establish a reasonable assurance of safety and effectiveness of the Nit-Occlud® PDA.

If an IDE is the Investigational Device Exemption application that is submitted to the US Food and Drug Administration to request permission to study a medical device in humans, it would seem logical to assume that 'pre-IDE' is another application submitted before the IDE.

The FDA pre-IDE meeting on the NanoTherm™ prostate cancer therapy pre-submission took place in January 2015, the Investigational Device Exemption for NanoTherm™ therapy to treat intermediate risk prostate cancer was filed with the FDA in May 2015.

The Company is confident that MagForce's extensive pre-clinical and clinical studies will provide the solid background for a timely submission of an Investigational Device Exemption (IDE) for the development of NanoTherm™ therapy in the US.

MagForce USA, Inc. had filed an Investigational Device Exemption (IDE) with the USA Food and Drug Administration (FDA) for NanoTherm therapy to treat Intermediate Risk Prostate Cancer.

Whether or not you intend to submit an IDE (Investigational Device Exemption) application, the pre-IDE process is the mechanism that the FDA has made available to sponsors to provide specific feedback on their preclinical and/or clinical test plans, and resolve questions of regulatory pathway.

Unlike the premarket authorisation process for new medical devices in the EU, where manufacturers/sponsors submit their technical files or design dossiers to Notified Bodies, the US Office of Device Evaluation of the Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH), has until recently been the sole reviewer of all premarket applications including applications for Investigational Device Exemption, premarket notifications and premarket approval applications.

The treatment of prostate cancer could therefore be the decisive driver for MagForce AG. Approval in this segment is initially intended in the USA, with a request for submission of a study protocol already having been sent to the FDA (U.S. Food and Drug Administration) and the filing of an Investigational Device Exemption is expected to be announced soon.

Our laboratory investigation methods and devices cover:

For this factor, we investigate the supported devices per antivirus software.

Here we investigate which devices are supported by the antivirus software, and which features are available.

Moreover, this revision provides the opportunity to align the provisions regarding clinical investigations on medical devices, where appropriate, with the recently adopted Proposal for a Regulation on clinical trials on medicinal products for human use3.

Finally, EU legislation currently does not make provision for any coordination between Member States regarding the assessment of applications for clinical investigations on medical devices to be conducted in more than one Member State.

The rules on clinical investigations should be in line with well-established international guidance in this field, such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical devices for human subjects, so as to make it easier for the results of clinical investigations conducted in the Union to be accepted as documentation outside the Union and to make it easier for the results of clinical investigations conducted outside the Union in accordance with international guidelines to be accepted within the Union.

The rules on performance studies should be in line with well-established international guidance in this field, such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical devices for human subjects, so as to make it easier for the results of performance studies conducted in the Union to be accepted as documentation outside the Union and to make it easier for the results of performance studies conducted outside the Union in accordance with international guidelines to be accepted within the Union.