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June 13, 2022
2 Min Read
BD and CerTest BioTec are teaming up to develop a molecular diagnostic test for the Monkeypox virus. The assay will use the BD MAX open system reagent suite to validate the CerTest Viasure Monkeypox CE/IVD molecular test on the BD MAX System. The assay will be available for BD MAX users and may help advance understanding of the global spread of the disease.
Illumina has cybersecurity vulnerabilities in some of the next generation sequencing software for its instruments, according to FDA. The agency released a notice June 2 about the affected software, which includes NextSeq 550Dx, the MiSeqDx, the NextSeq 500, NextSeq 550, MiSeq, iSeq, and MiniSeq. FDA said the cybersecurity vulnerability affects the Local Run Manager (LRM) software and an unauthorized user could exploit the vulnerability by: Taking control of the instrument remotely; operating the system to alter settings, configurations, software, or data on the instrument or a customer’s network; or impacting patient test results in the instruments intended for clinical diagnosis, including causing the instruments to provide no results or incorrect results, altered results, or a potential data breach.
And in case you missed our last Medtech in a Minute report...
Just ahead of the American Diabetes Association's 82nd Scientific Sessions, Abbott nabbed FDA clearance for its FreeStyle Libre 3 system for people four years and older living with diabetes. FDA clearance comes nearly two years after the Libre 3 system received a CE mark for use in Europe. Libre 3 is currently considered the smallest and most accurate continuous glucose monitoring (CGM) sensor on the market.
Medtronic has snagged FDA approval for a device built on equivalent technology to the In.Pact Admiral drug-coated balloon (DCB). The device is indicated for the percutaneous transluminal angioplasty of de novo, restenotic, or in-stent restenotic lesions with lengths up to 360 mm with vessel diameters of 4-7 mm. The approval brings to mind the 2019 controversy over paclitaxel balloons and stents, the data discrepencies around which befuddled an FDA committee that year.
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