Keeping you up to date on recent developments in diagnostics, including: Deep learning enables real-time prediction of acute kidney injury; Catching kidney injury early in children; Seeing where tau goes wrong.
Investigators at the National Institute of Allergy and Infectious Diseases have identified physiological factors that are not diseases in the narrow sense, but that nevertheless have large effects on microbiome composition.
The U.S. FDA’s stated policy is that it will not review emergency use authorizations (EUAs) for lab-developed tests (LDTs) for the COVID-19 pandemic, but that doesn’t mean labs are completely shut out. The FDA’s Toby Lowe said that a lab that wants to pair an assay that already has an EUA with a new software installation on lab instrumentation can work with the assay developer to update that EUA.
LONDON – The U.K.’s influential health technology assessment body, the National Institute of Health and Care Excellence (NICE), is consulting stakeholders on proposed changes to how it selects medical devices, diagnostics and drugs for evaluation.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS plans retrospective regulatory review.
Haemonetics Corp. reported sales of $209.5 million for the second quarter of fiscal year 2021, down 17.1% from the same period the prior year. Plasma sales declined 32.4% year over year to $78.4 million in the face of continuing COVID-19 impacts on blood donor activity. As Jeffries analyst Anthony Petrone observed, “Trough is rear view but plasma headwinds still elevated” through the period ended Sept. 26, “though declines were lower than expected (actual -30%; JEF -28% cc).”
Royal Philips NV is reporting the launch of Philips Ventilator Bipap A40 EFL, a noninvasive ventilator that aims to help patients with chronic obstructive pulmonary disease (COPD) breathe easier. With its CE mark in hand, the company has tagged initial target markets as France, Italy and the U.K. Additional European markets are expected to come next year.
By analyzing patients’ reactions to treatment, Oncohost Ltd.’s proteomics-based platform enables earlier prediction of paradoxical responses to immunotherapy that promote tumor growth in certain cancers. The artificial intelligence-powered host response profiling platform, called Prophet, could help identify the best combination of therapies and minimize adverse effects from treatments that are unlikely to be beneficial.
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