Medical Monitoring News
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Aurealis Therapeutics Pioneering Multiple Drug Producing Bacteria Aup-16 Dosed to The First Diabetic Foot Ulcer Patient in The Phase 1-2a Trial
Aurealis Therapeutics, a private clinical-stage biopharmaceutical company developing AUP-16, the three-in-one combination biologic drug for chronic non-healing wounds and regenerative diseases, announced today that the first diabetic foot ulcer (DFU) patient has been dosed with AUP-16. The trial is performed in non-healing DFU patients and is designed to evaluate the safety, tolerability and ...
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Vela Diagnostics Submitting Novel Coronavirus Diagnostic Test to FDA for Emergency Use Authorization (UPDATE)
Vela Diagnostics has developed the ViroKey SA201 SARS-CoV-2 RT-PCR Test, a new diagnostic test for the detection of COVID-19. Vela Diagnostics is currently in discussions with the U.S. Food and Drug Administration (FDA) for authorization of the test under the emergency use authorization (EUA). The EUA will allow the emergency use of FDA medical products in qualified labs, thereby facilitating ...
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JenaValve Technology Closes $50 Million Financing
JenaValve Technology, Inc., developer and manufacturer of the JenaValve Pericardial Transcatheter Aortic Valve Replacement (TAVR) System for the treatment of aortic valve disease, announces that it has raised $50 million in an equity financing led by Bain Capital Life Sciences. Additional participants in the financing included existing investors Andera Partners, Gimv, Legend Capital, NeoMed ...
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AdjuCor enters BMBF supported research collaboration for developing 3D printable biomimetic polymers that mimic properties of the pericardium.
MUNICH, Germany – February 4th, 2020: In the future, novel polymers should make it possible to individually manufacture artificial elastic tissue replacements for pericardium, heart valves or blood vessels. In the PolyKARD project, biomimetic polymers are being developed that can imitate the mechanical properties of pericardial tissue. Using 3D printing and electrospinning, these ...
By AdjuCor GmbH
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Rebiotix, a Ferring Company, Completes Enrollment for First-Ever, Pivotal Phase 3 Clinical Trial of Microbiota-based RBX2660
Enrollment completion for the first Phase 3 clinical trial in microbiome industry Largest randomized, double-blinded study, with over 300 patients enrolled aimed to demonstrate the potential benefit of RBX2660 in reducing rates of recurrent Clostridioides difficile (C. diff) infection Rebiotix intends to use the results from the Phase 3 trial to serve as the basis for licensure application to ...
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Solvay Ventures invests in Invizius
Solvay Ventures announces today its equity investment in Invizius, the University of Edinburgh spin-out developing potentially lifesaving products that reduce complications rates suffered by dialysis patients. Solvay Ventures invests alongside Mercia Asset Management, Downing Ventures, the University of Edinburgh’s Old College Capital fund and the Scottish Investment Bank. Invizius is ...
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UNITY Biotechnology Announces Restructuring to Advance Corporate Strategy and Focus on Key Ophthalmology Programs
Strategic realignment to focus capital resources on clinical programs and extend cash runway into Q1 2023 12-week data from Phase 2a study of UBX1325 in diabetic macular edema (DME) expected mid-2022 16-week data from Phase 2 study in wet age-related macular degeneration (wet AMD) expected in Q4 2022 UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company ...
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Ancora Heart Announces Expansion of U.S. Early Feasibility Study
Santa Clara, Calif.– February 3, 2020 – Ancora Heart, Inc., a company developing a novel therapy to address heart failure, today announced that the U.S. Food and Drug Administration (FDA) has approved an expansion of enrollment in its CorCinch HFrEF Early Feasibility Study (EFS), which is evaluating the AccuCinch® Ventricular Repair System in patients with reduced ejection ...
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Lungpacer Medical, Inc. Presents Preclinical Results at Society of Critical Care Medicine, February 2020, Orlando, Florida
The Society of Critical Care Medicine (SCCM) is the largest non-profit medical organization dedicated to promoting excellence and consistency in the practice of critical care. With members in more than 100 countries, SCCM is the only organization that represents all professional components of the critical care team. Lungpacer Medical is pleased to announce the presentation of preclinical work on ...
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Lungpacer Medical, Inc. Presents Preclinical Results at the European Respiratory Society’s Respiratory Failure & Mechanical Ventilation Conference, February 2020, Berlin, Germany
The inaugural ERS Respiratory Failure and Mechanical Ventilation conference gathered more than 400 delegates from 60 countries, representing a diverse mix of world-leading respiratory scientists, clinicians and allied healthcare professionals. Delegates witnessed more than 40 scientific sessions and there were over 70 abstracts presented, featuring cutting-edge clinical and scientific ...
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Vela Diagnostics Announces Development of New Test Kit for Detection of Wuhan Coronavirus
Vela Diagnostics has announced the development of the ViroKey SA201 2019-nCoV RT-PCR Test, a new test kit for the detection of the 2019 Novel Coronavirus (2019-nCoV), otherwise known as the Wuhan Coronavirus. The Wuhan Coronavirus was first identified in mid-December 2019 in Wuhan, China. Human-to-human transmission has been confirmed by China’s health ministry. According to Chinese health ...
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Eugia Pharma receives USFDA Approval for Methotrexate Tablets
Aurobindo Pharma Limited is pleased to announce that its joint venture company, Eugia Pharma Specialities Limited, has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Methotrexate tablets, 2.5 mg. Methotrexate tablets are generic version of Dava Pharmaceuticals’ Rheumatrex Tablets. The product will be launched in March 2020. The ...
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Eurofins Biomnis and Seqone Partner to Improve Clinical Access to Whole Exome Testing
Eighty percent of rare diseases are genetic in origin and result from a small number of genetic mutations. Identifying these variations is essential in diagnosing the diseases and can dramatically improve patient care. Making Whole Exome sequencing more affordable to improve diagnostic efficiency Since 2017, Eurofins Biomnis has offered “Whole Exome” sequencing which, starting from ...
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Research Presented at LINC Suggests the Profusa Lumee® Oxygen Platform May Improve Clinical Management of Patients with Critical Limb Ischemia
Profusa, a digital health company that is pioneering the next generation of personalized medicine, today announced research findings that suggest the company’s Lumee® Oxygen Platform may help improve the clinical management of patients with critical limb ischemia (CLI) who are undergoing endovascular revascularization treatment (EVT). The data, from a recent post-market clinical study ...
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MedBiome licenses the RapidAIM technology from the University of Ottawa
MedBiome is pleased to announce that it has exclusively licensed the RapidAIM technology from the University of Ottawa. RapidAIM is a revolutionary assay to rapidly determine the effects of compounds on individual human living microbiomes. RapidAIM fidelity maintains functional living human microbiomes in 96 well plates and allows the testing of drugs for their effects on the ...
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Oxitone Medical has launched mass-production of new generation devices
We are excited to announce that Oxitone Medical, a world leader in wrist-wearable medical technologies, has begun mass-producing and delivering the new generation of the world’s first FDA-cleared wrist-sensor pulse oximetry monitor to our customers. In the last few months, we have been tirelessly working to release a new generation product with extended capabilities. We believe that our ...
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Profusa Receives CE Mark Approval to Market the Wireless Lumee® Oxygen Platform for Continuous, Real-Time Monitoring of Tissue Oxygen
Profusa, a digital health company that is pioneering the next generation of personalized medicine, today announced it has received Conformité Européenne (CE) Mark approval to market its Wireless Lumee® Oxygen Platform for continuous, real-time monitoring of tissue oxygen in patients with potential acute and/or chronic changes in tissue oxygen levels who may benefit from ...
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Mauna Kea Technologies Receives FDA 510(k) Clearance of Cellvizio® with a Fluorescent Dye, Fluorescein, as Drug Device Combination
The Cellvizio®100 series system with all its different Confocal Miniprobes™ is now cleared for use with the fluorescein dye to image blood flow in the microvasculature and capillaries Mauna Kea Technologies today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Cellvizio® 100 series and all associated Confocal Miniprobes™ for ...
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Training and consultancy for Analyse-it
Our focus at Analyse-it has always been on the development and improvement of our software. While we provide extensive help, tutorials, and technical support for Analyse-it, one area we do not cover is training and consultancy. As many of you will know we are based in England in the United Kingdom, and providing training and consultancy is often done better locally, in-person. Instead we ...
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New study: Nine out of ten U.S. infants experience gut microbiome deficiency
A new peer-reviewed study reveals that the vast majority of U.S. infants may be suffering from a substantial deficiency in an important bacterium key to breast milk utilization and immune system development, as well as protection against gut pathogens linked to common newborn conditions such as colic and diaper rash. According to the study published today in Scientific Reports, approximately ...
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