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Clinical Performance Services
52 services found
Manufactured by:Bluegrass Vascular Technologies, Inc. based inSan Antonio, UTAH (USA)
The international SAVE ( Surfacer® System to Facilitate Access in VEnous Occlusions) Registry demonstrated clinical performance and safety of the Surfacer Inside-Out® Access Catheter System used to facilitate the entry and placement of central venous access catheters in patients with limited or diminishing upper body venous ...
Manufactured by:Bluegrass Vascular Technologies, Inc. based inSan Antonio, UTAH (USA)
The SAVE-US (Surfacer® System to Facilitate Access in VEnous Occlusions – United States) pivotal trial demonstrated positive clinical results, confirming clinical performance and safety of the Surfacer Inside-Out® Access Catheter System to facilitate the entry and placement of central venous access catheters in patients with limited ...
Manufactured by:Self-screen B.V. based inAmsterdam, NETHERLANDS
Self-screen is constantly developing novel state-of-the-art clinical tests for (early) cancer detection. These tests meet growing requirements in both primary screening as well as triage settings. This could be in terms of terms of validation of certain sample types, such as existing cytology preservatives, or other media, or for instance new sample types such as self sampling ...
Manufactured by:Resonetics based inNashua, NEW HAMPSHIRE (USA)
Validation and Pre-Production Phase: Design and processes are validated to get the product ready for commercial production. Limited runs may be performed for clinical studies. Design Transfer to Production Phase: Product design is officially transferred from R&D to commercial ...
Manufactured by:Elite Biomedical Solutions, LLC based inCincinnati, OHIO (USA)
Elite Biomedical Solutions provides on-site service and repairs that keep clinical equipment performing at optimal ...
by:Biodesix based inBoulder, COLORADO (USA)
Evidence-based clinical research; We are committed to continuously add to our growing body of clinical evidence by publishing and presenting new data and insights on the clinical validation and utility of our diagnostic ...
Manufactured by:Ulisse BioMed based inUdine, ITALY
As a provider of excellent molecular diagnostic solutions, ULISSE BIOMED offers to customer the development of customized solution tailored to any need, working in any phase of the project. Because your success is our ...
by:Biostrap USA, LLC based inBradbury, CALIFORNIA (USA)
Building your own wearable and digital health solution is expensive and time-consuming. Biostrap Connect makes it affordable and ...
by:Hookipa Pharma Inc. based inVienna, AUSTRIA
The objective of the Hepatitis B virus (HBV) Program is to utilize the HOOKIPA Technologies to design arenavirus vectors (Lymphocytic Choriomeningitis Virus or Pichinde Virus based) suitable for treatment, cure or prevention of HBV. Together with our partner Gilead Sciences we intend to develop functional therapies for patients already infected with ...
Manufactured by:ResMetrix Medical Ltd based in, ISRAEL
Resmetrix clinical results show high correlation between respiratory signals from Resmetrix’ strap and a spirometer/flow meter tidal volume signals. In asthmatic patients, the system detected successfully changes in respiratory patterns during mild attack and response to treatment. Studies in exercise, the system demonstrate the ability to continuously and accurately monitor the respiratory ...
by:Avaden Biosciences, Inc. based inSeattle, WASHINGTON (USA)
Method comparison studies, interlaboratory reproducibility studies, enrollment studies, exploratory staining studies, digital pathology primary diagnosis , validations, new instrument ...
by:North American Science Associates Inc.(NAMSA ) based inNorthwood, OHIO (USA)
Delivering a medical product to market can be a long and complicated process, even when you’re familiar with the regulatory requirements.But when requirements are rapidly changing or when you’re entering international markets, the process can seem ...
by:Click Therapeutics, Inc based inNew York, NEW YORK (USA)
Deliver effective treatments to your patients. Our clinically validated software programs are designed to deliver effective treatments to your patients while offering the favorable safety profile inherent to a digital ...
Manufactured by:Resolution Medical based inFridley, MINNESOTA (USA)
Class I, II, III products from idea/concept through commercialization. Solid Modeling and Prototyping. Extensive 3D Printing. Bench model development & testing. Pre-clinical study support. Engineering Feasibility Studies. Design and Development. Test Method Development & Validation. Design Verification Testing. Design Validation Testing. Process Development and Validation. Clinical and ...
Manufactured by:Humworld Inc. based inWixom, MICHIGAN (USA)
Integrating behavioral health care with primary care (“behavioral health integration” or “BHI”) is an effective strategy for improving outcomes for people with mental or behavioral health ...
by:Simeks based inIstanbul, TURKEY
Simeks can take your medical device project from the initial idea to the end product on the market. When customers have an exclusive design idea, a new solution to an existing clinical need, or a performance target to achieve, Simeks can plan and manage a product development project by sharing its R&D and manufacturing ...
Manufactured by:Novela Neurotech based inIrvine, CALIFORNIA (USA)
The SPEAC® System is a portable system designed to monitor and analyze surface electromyography (EMG) signals that may be associated with generalized tonic-clonic (GTC) seizures and to provide an alarm to alert caregivers. The System provides adjunctive monitoring during periods of ...
by:Burning Rock Biotech Limited based inGuangzhou, CHINA
Burning Rock offers integrated companion diagnostic development services for biopharma partners to streamline the co-development and commercialization of targeted drugs and respective CDx （including registration testing, clinical evaluation and finally obtain registration certificates. Our US-based lab and R&D team provide additional services to promote drug and CDx ...
by:ACMIT Gmbh based inWiener Neustadt, AUSTRIA
From the initial idea to the clinical application of a medical technology product, many development steps are to take and obstacles to overcome. ACMIT is your ISO-13485 certified partner during the complete innovation process and offers expertise, guidance and assistance in every single step. ...
Manufactured by:Veracyte based inMarseille Cedex 9, FRANCE
Veracyte’s professional framework for clinical trial assay (CTA) and companion diagnostics (CDx) development allows our clients to confidently advance priority projects. With an end-to-end service infrastructure, we support all aspects of assay development, manufacturing, life cycle management, regulatory submissions, marketing support, and commercialization for our ...