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Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
Diagnostics RSS Feed RSS

FDA clears INDs for targeted alpha therapy FPI-1966 and imaging agent FPI-1967

July 29, 2021

Clarity initiates phase I/IIa theranostic trial of 64/67Cu SAR-bisPSMA in metastatic CRPC

July 29, 2021
Red blood cells, DNA

BCAL Diagnostics raises A$10M in IPO to develop blood-based breast cancer IVD

July 28, 2021
By Tamra Sami
PERTH, Australia – After raising A$10 million (US$7.36 million) in its initial public offering on the Australian Securities Exchange, BCAL Diagnostics Ltd. is racing to commercialize its noninvasive, blood-based in vitro diagnostic to detect breast cancer. The Breast Cancer Associated Lipids (BCAL) test is taken via a blood sample and analyzed for lipid biomarkers.
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Photo of panel box, collection tubes

Access Biologicals develops seroconversion panels for COVID-19 vaccine

July 27, 2021
By Annette Boyle
Access Biologicals LLC brought online newly released seroconversion panels that measure the level of antibodies against SARS-CoV-2 in blood samples, allowing researchers to determine vaccine efficacy. The panels can detect the point when seroconversion occurs and assess the efficacy of a vaccine against new and existing strains of the novel coronavirus. To build the panels, the Vista, Calif.-based company collected blood samples prior to vaccination and after the first and second doses. The plasma was then tested for IgG antibodies to the S1 and S2 spike proteins of the novel coronavirus using enzyme-linked immunosorbent assays (ELISA) and chemiluminescent assays (CLIA).
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Coronavirus, lungs, hand holding stethoscope

Memed adapts POC test for COVID-19 severity assessment

July 27, 2021
By Nuala Moran
LONDON – Memed Diagnostics Ltd. has adapted the point-of-care test it developed to distinguish bacterial from viral infections to enable rapid assessment of the severity of COVID-19 infections in patients being admitted to the hospital. The triaging tool, Memed COVID-19 Severity, has received a CE mark in Europe and is ready for commercial rollout. After securing the CE mark, Memed is now pursuing emergency use authorization for the test from FDA.
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Brain illustration

International researchers develop dementia diagnostic algorithm

July 26, 2021
By Annette Boyle
Researchers from Finland and Italy published a biomarker-based algorithm for the diagnosis of dementia in the journal Diagnostics. The algorithm enables clinicians to distinguish between various neurodegenerative diseases with shared clinical presentations and select appropriate treatment. The algorithm relies primarily on blood biomarker measurements to diagnose the type of dementia much earlier than is possible with the diagnostic tools in use today.
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Hand holding ADAMM-RSM device

Wearable asthma device tested for its prediction of chronic pulmonary disease

July 26, 2021
By David Godkin
TORONTO – What do ER doctors want most for their patients? Never to return to the ER, said Giovanni Ferrara, a professor at Edmonton’s University of Alberta Hospital's Division of Pulmonary Medicine. Ferrara is heading a feasibility project to see if a wearable device developed by Rochester, N.Y.-based Heath Care Originals Inc. can predict with scientific certainty when the condition of a patient with lung disease is worsening and requires another visit to the hospital.
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Philips cardiac MRI scanner

Philips working on MRI protocol that can analyze the heart in less than a minute

July 23, 2021
By Bernard Banga
PARIS – Royal Philips NV is working with the Spanish National Center for Cardiovascular Research (CNIC) on an ultrafast cardiac magnetic resonance imaging (MRI) protocol that could reduce scanning times to just a few minutes.
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Respiratory infection

Owlstone bid to use masks for COVID-19 detection meets a dead end, may prove useful for other conditions

July 23, 2021
By Nuala Moran
LONDON – An attempt to develop an alternative sampling method to replace unpleasant nasopharyngeal swabbing in COVID-19 diagnosis has failed, with researchers at Owlstone Medical Ltd. finding the number of viral particles that can be collected from the breath of hospitalized patients is below the limit of detection. Owlstone is a specialist in collecting and analyzing breath samples to look for volatile organic compounds that are biomarkers of disease, such as lung cancer and asthma.
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Brandon Suh and Helmy Eltoukhy shaking hands

Lunit secures $26M in funding and reveals future Guardant partnership

July 22, 2021
By Gina Lee
Lunit Inc. snagged a $26 million investment from precision oncology company from Guardant Health Inc., closing its series C tranche B funding round. Lunit is planning to use the funds to develop more artificial intelligence (AI) solutions and improve existing ones.
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