Recently, Wondfo Biotech's wholly-owned subsidiary in the United States, Wondfo USA Co., Ltd. (hereinafter referred to as the " Wondfo USA"), received notification from the U.S. Food and Drug Administration (FDA) that the WELLlife™ COVID-19/Influenza A&B Test has been granted Emergency Use Authorization (EUA240004). The WELLlife™ COVID-19/Influenza A&B Test is designed for professional use at the point-of-care (POC) settings.
Group sales grew by 2%1 at constant exchange rates (CER) (-6% in CHF), driven by the strong growth of newer medicines and diagnostics. Excluding COVID-19-related products, sales increased by 7%. Going forward, there will be no further material impact of COVID-19 sales decline
QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho" or the “Company”) has received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for its QuickVue COVID-19 test. This clearance allows the test to be used with accuracy and convenience in home and medical facility settings with CLIA certificates of waiver. This achievement also reflects QuidelOrtho’s dedication to delivering effective testing solutions while highlighting ongoing efforts in research and development to enhance market competitiveness.
The US Food and Drug Administration last week granted Emergency Use Authorizations for two point-of-care COVID-19 and influenza combination tests developed by Sekisui Diagnostics.
Group sales grow by 1% at constant exchange rates (CER; -7% in CHF), more than offsetting the decline in COVID-19-related sales and biosimilar erosion, and thereby exceeding 2023 guidance
Abbott Laboratories (NYSE:ABT) posted higher sales of $10.24 billion in the fourth quarter, despite continued soft demand for the company’s Covid-19 testing equipment, beating the consensus of $10.18 billion.
SEKISUI Diagnostics, a global medical diagnostics manufacturer, has formalized an exclusive distribution agreement with Aptitude Medical Systems (Aptitude™), an innovative developer of decentralized molecular diagnostics, to sell the Aptitude MetrixTM COVID-19 Test in the U.S. The Metrix test is currently the only EUA approved, molecular test which can be used with both swab and saliva samples and can performed by healthcare professionals or at home by consumers.
Virax Biolabs said on Thursday that it has formed an alliance with the University of Manchester and Northern Care Alliance Foundation Trust, a member organization of the UK's National Health Service, to investigate T-cell responses in long COVID-19 patients.
Siemens Healthineers reported Wednesday that its non-COVID-19 revenues rose about 11 percent year over year on a comparable basis in its fiscal fourth quarter with strong growth in its Varian Medical Systems and imaging segments, along with low-single-digit growth in its diagnostics segment.
Group sales grow by 1% at constant exchange rates (CER) in the first nine months, showing a strong increase of 7% in the third quarter.
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