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Clinical Validation Services In Usa
34 services found
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: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 ...
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 ...
by:Natera, Inc. based inAustin, TEXAS (USA)
Why partner with Signatera for your clinical trial? Clinically validated across multiple solid tumors, Signatera has shown to predict relapse in >98% of patients without further treatment. Experienced team with Global reach: CE Mark, three FDA Breakthrough Device Designations, 8 Non-Significant Risk (NSR) determinations. ...
Manufactured by:Resonetics based inNashua, NEW HAMPSHIRE (USA)
Design Verification Phase: The product is submitted to extensive design verification testing to objectively demonstrate that the design outputs can satisfy the design inputs. 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 ...
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: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: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: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 ...
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. ...
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 ...
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 ...
Manufactured by:Siemens Healthcare GmbH based inErlangen, GERMANY
The PRECISION Study was a multicenter, post-market registry of robotic PCI using the Corindus CorPath 200 System. The purpose of the study was to collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath 200 System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters during PCI ...
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 or diminishing upper body venous ...
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 ...
by:CareDx, Inc based inSouth San Francisco, CALIFORNIA (USA)
KidneyCare is a multimodality surveillance solution for kidney transplant patients. It includes AlloSure® Kidney, AlloMap Kidney, and KidneyCare ...
by:Strados Labs based inPhiladelphia, PENNSYLVANIA (USA)
Beyond Cough Count: RESP Cough Trial Solution (CTS) optimizes chronic cough trials to better capture lung sound biomarkers. RESP allows clinical endpoints for coughs to be captured and show positive results. A portion of these positive results revolve around being able to differentiate between voluntary coughs vs. involuntary coughs to determining if the drug is working as planned. RESP makes ...
by:Castle Biosciences, Inc. based inFriendswood, TEXAS (USA)
A Focus on Transforming Disease Management. Our approach to product development starts by identifying areas of unmet medical need where precision medicine could significantly improve disease staging and/or patient care decisions. We focus first on confirming the clinical challenges of these unmet needs and look for opportunities where current staging or standards of care do not sufficiently ...
by:Watermark Medical based inWest Palm Beach, FLORIDA (USA)
Watermark Medical understands the demands and challenges in delivering innovative patient services in a rapidly changing healthcare environment. We provide simple and efficient solutions to enable the delivery of home sleep diagnostics for your practice. We offer Home Sleep Test solutions through a secure, cloud-based, accessible platform. This platform supports and provides access to ...