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Becton Dickinson on Tuesday became the latest testing manufacturer to express confidence that both its rapid antigen and PCR tests will detect the variant, which the World Health Organization says poses a "very high" risk.
The agency joined the chorus of top testing manufacturers, including Abbott Laboratories, Quidel and Thermo Fisher Scientific, claiming that current coronavirus diagnostics can accurately identify the omicron variant.
The agency has authorized another three over-the-counter COVID-19 antigen home tests for single use in people with symptoms, furthering the emergence of the kits as an alternative to PCR.
The In Vitro Diagnostic Medical Devices Regulation panel, which got off to a rocky start earlier this year, provided a glowing assessment of a test by an undisclosed company that screens plasma donor samples for hepatitis E virus.
The FDA-funded guide arrives against a backdrop of calls from the agency for the medtech industry to step up its threat modeling throughout the device lifecycle in order to strengthen cybersecurity and patient safety.
FDA says manufacturers and hospitals are both responsible for protecting devices from growing cybersecurity threats. However, healthcare organizations carry a much heavier load.
As healthcare recovers after COVID-19, questions remain about what lasting effects the pandemic will have on MedTech. Explore the state of the market in this on-demand webinar.
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