clinically validate News
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Review our webinar: Clinical Validation of HPV assays on the NeuMoDx Platform
Self-screen’s Chief Scientific Officer dr. Bart Hesselink talks about the clinical validation of QIAGEN’s next generation HPV screening assay on the NeuMoDxTM Molecular Systems. The NeuMoDxTM 288 and NeuMoDxTM96 Molecular Systems are fully automated continuous random-access analyzers that perform adequately in standardized, high volume cervical cancer HPV screening laboratories. The ...
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Vektor Medical Initiates Clinical Study of vMap
Vektor Medical, Inc. announced the start of its clinical study to evaluate vMap™. Using patients who have previously undergone a clinically-indicated electrophysiology study and successful ablation, the purpose of this study is to clinically validate the use of vMap™ in providing arrhythmia/pacing hotspots for analysis by a physician. vMap™ has been designed as the next ...
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Showcase
Neeuro (Singapore) and epihunter (Belgium) partner to create new and innovative digital solutions for people with brain disorders
On March 15th 2015, Tim Buckinx’ son said: “Papa, you work in digital, can’t you create a light that turns on when my brain switches off?” At ten years old, he was simply fed up with the daily impact of his refractory epilepsy. That pain became a vision, and that vision became the Belgian digital therapeutics company epihunter, aimed at enabling people with a brain ...
By Epihunter NV
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Unilabs Sweden Launches Subtle Medical’s AI-powered Imaging Technology to Further Bolstering Patient Care
Unilabs, the leading diagnostic services provider, announced a partnership with Subtle Medical, a healthcare technology company using artificial intelligence for faster and higher quality MRI, to further improve the quality and efficiency of their MRI imaging. The solution, which will first be rolled out in Sweden, will boost Unilabs’ MRI programme to provide industry-leading productivity ...
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Showcase
Corify Care raises €2.35M to translate its cardiac mapping technology to the market. .
- Corify Care is developing ACORYS®, a non-invasive cardiac mapping medical device to transform the cardiac arrhythmia treatment process. - The investment round is led by Clave Capital, counting with investment from CDTI through its Innvierte program and the support from Genesis Biomed. Corify Care, the developer of an innovative and completely non-invasive cardiac mapping system, ...
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Showcase
Empatica partnering with U.S. Army MRDC to deploy COVID-19 early detection wearable
BOSTON, Nov. 6, 2020 /PRNewswire/ -- Empatica has been selected by the U.S. Army Medical Research and Development Command (USAMRDC) to deploy a wearable and algorithm that enable the early and pre-symptomatic detection of COVID-19. The project's focus is on protecting the health of the general population by preventing outbreaks via early detection and alerting. Empatica's Aura algorithm gives a ...
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Q’Apel Medical Welcomes Thomas Berryman, Chief Financial Officer
Q’Apel Medical, Inc., an innovative neurovascular company specializing in developing and commercializing novel access device technology for vascular interventions, is pleased to announce and welcome Thomas Berryman as Chief Financial Officer. Tom has extensive experience in bringing venture funded medical technology companies from initial startup through product commercialization, revenue ...
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iRhythm launches Clinical Resource Center for clinicians’ convenience
iRhythm Technologies, Inc. is excited to announce the addition of a Clinical Resource Center (CRC) to its website. The CRC was designed to make it easy for clinicians to access clinical evidence, on-demand webinars, and case studies through one centralized location. Clinicians will use the CRC as a gateway to published clinical articles. Summaries of significant ...
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Interpace Biosciences Announces New Clinical Validation Data; Diagnostic Accuracy Significantly Improved
Interpace Biosciences, Inc. (“Interpace” or the “Company”) (OTCQX: IDXG), a fully integrated commercial company that provides clinically relevant molecular diagnostic tests and pathology services for improved patient diagnosis and management, today announced new clinical validation data for their thyroid cancer test platform which is comprised of a mutation panel ...
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Vektor Medical to Present Positive Results from vMap Clinical Validation Study Showing 97.3% Mapping Accuracy for Atrial and Ventricular Arrhythmias
Non-invasive arrhythmia technology maps using only the data from a 12 lead ECG vMap provides actionable mapping results in minutes. Blinded, multi-center study with analysis by an independent core laboratory Results to be presented for the first time at Heart Rhythm 2022 Vektor Medical today announced positive results from its “Vektor vMap™ Clinical Validation ...
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Congratulations! Reetoo COVID-19 Ag Self-Test kit obtained CE certification
Recently, Reetoo SARS-CoV-2 Antigen Rapid Self-test Kit (Colloidal Gold) received CE certification accredited by CeCert Sp. z o.o. and completed clinical validation in Vitalabo Laboratoria Medyczne Sp. z o.o. according to the latest EU guidance MDCG 2021-21 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic, which means this product gained official access to the EU market. ...
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Restech announces the clinical validation of the Resmon Pro Diary to remotely monitor COPD at home.
The CHROMED trial, one of the largest clinical trial using FOT to monitor remotely COPD patients and prevent exacerbation has now been published on the American Journal of Respiratory and Critical care medicine! Using the RESMON PRO DIARY (the home version of the well proven, hospital, clinical unit, the RESMON PRO FULL), 312 patients from 5 different European countries have been successfully ...
By Restech Srl
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Bio-Techne`s Exosome Diagnostics Laboratory Announces CE-IVD Certification for Exodx Prostate Test
Bio-Techne Corporation (NASDAQ:TECH) today announced that Exosome Diagnostics, a Bio-Techne brand, has completed its clinical validation of an in vitro diagnostic (IVD) version of the ExoDx™ Prostate test (EPI) kit enabling self-certification as CE-IVD as of March 22, 2021. Bio-Techne Corporation (NASDAQ:TECH) today announced that Exosome Diagnostics, a Bio-Techne brand, has ...
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Showcase
Empatica and BARDA Join Forces to Validate Wearable System That Detects COVID-19 Before Symptoms Appear
BOSTON, June 19, 2020 /PRNewswire/ -- Digital healthcare company Empatica announces a pioneering new partnership with the Biomedical Advanced Research and Development Authority ("BARDA"), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), to validate an early warning system for COVID-19 and other respiratory ...
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Acurable launches groundbreaking technology to diagnose sleep apnoea remotely
Acurable, a fast-growing medical device company, has announced the availability of its first product, AcuPebble SA100, a small wearable device which for the first time enables a fully automated and remote diagnosis of obstructive sleep apnoea (OSA). Traditionally, the diagnosis of OSA has required multiple hospital visits for patients, and doctors have had to manually review and analyse data from ...
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Co-creative Innovation with BioWin
ONCOMFORT, GIGA CONSCIOUSNESS, ISIA LAB AND PILIPILI LAUNCH A CO-CREATION PROJECT WITH SUPPORT OF THE BIOWIN HEALTH CLUSTER FRAMEWORK The project aims at objectivizing Digital Sedation™, paving the way for the first management system for non-pharmacological sedation for use in daily clinical practice. In 2017, Oncomfort created a medical device for Digital Sedation™, a digital ...
By Oncomfort
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Appointment Michelle Meijer as Chief Commercial Officer
Self-screen is proud to announce the appointment of Michelle Meijer, PhD, as the companies Chief Commercial Officer. Michelle brings over 25 years of business experience in the life sciences and molecular diagnostics field, of which more than 15 years in the field of cervical cancer prevention and HPV diagnostics in particular. She held several senior business development and management roles at ...
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InnovHeart appoints David Wilson as Chief Executive Officer
InnovHeart s.r.l. announced today the appointment of David James Wilson, an experienced healthcare and medical device executive as Chief Executive Officer of the company and executive member of the Board of Directors. Mr. Wilson’s career spans over 30 years and includes broad, global leadership expertise in business strategy and operations, R&D, commercial readiness and product ...
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Cytovale Begins Enrollment in FDA 510(k) Clinical Validation Study of IntelliSep Rapid Sepsis Test
Cytovale, a medical diagnostics company focused on providing a faster, more insightful way to diagnose fast-moving and immune-mediated diseases, today announced the first enrollment in a clinical trial of the Cytovale system and IntelliSep test to aid in the rapid assessment of potential for sepsis in the emergency department (ED). The trial, A Clinical Validation Solving the Question of ...
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Cleveland Diagnostics Presents New Data Supporting the Clinical Validation and Clinical Utility of IsoPSA at the 2021 Annual Meeting of American Urological Association
Cleveland Diagnostics, Inc., a commercial stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, announced today that Eric Klein, MD, Chairman of the Glickman Urological & Kidney Institute at Cleveland Clinic, delivered two presentations at the annual meeting of the American Urological Association regarding the company’s prostate ...
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