iSono Health receives US FDA approval for breast imaging ultrasound system
ATUSA scans the entire breast volume automatically and provides 3D visualisation of the tissue in just two minutes.
Diagnostic Imaging
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Diagnostic Imaging
FDA warns of false results in genetic non-invasive prenatal testing
Neither the accuracy nor the efficacy of non-invasive prenatal testing (NIPT) has been authorised, cleared or approved by the FDA.
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SeekIn to launch LeukoPrint Molecular Karyotyping Test in Europe
The test is also suitable for other forms of haematological malignancies, such as multiple myeloma.
Proof Diagnostics seeks EUA for Covid-19 molecular diagnostic test
The Proof Lab Test System is expected to become the first POC system to use CRISPR-based nucleic acid detection.
Australian TGA approves Seegene’s Allplex RV Master Assay
Medical specialists can use the syndromic test to identify the virus making a patient sick from one sample.
C2i Genomics introduces minimal residual disease test for cancer in Europe
C2inform eliminates the need for patient-specific assay development and offers a rapid solution for cancer patients.
KSL Diagnostics introduces new antibody test for Covid-19
The blood test measures antibodies that are specific to Covid-19, which develop in response to vaccination or infection.
US FDA grants EUA for Helix COVID-19 self-collection kit
The Helix COVID-19 Self-Collection Kit will be available to consumers from participating pharmacies and urgent care centres.