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Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today reported its financial results for the fourth quarter and year ended December 31, 2023.2024-02-29View More
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In 2023, a total of 12,213 first registrations, renewals of registrations and changes of registrations of medical devices were approved by NMPA, representing an increase of 2.3% in the total number of registration approvals compared with 2022.2024-02-28View More
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OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care and home diagnostic tests, sample management solutions, and microbiome laboratory and analytical services, today announced its financial results for the three months ended December 31, 2023.2024-02-28View More
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Agilent Technologies Inc. (NYSE: A) today reported revenue of $1.66 billion for the first quarter ended Jan. 31, 2024, a decline of 5.6% reported and 6.4% core(1) compared to the first quarter of 2023.2024-02-28View More
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At the early stage of development of chemiluminescence in China, many manufacturers have gone through a road of breakthrough of unique items in the market, and of course, the expansion of some items has also provided important value to clinical practice.2024-02-27View More
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EnsoData has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its machine learning-based diagnostic for sleep apnea and other sleep disorders that uses data from pulse oximetry (pulse ox) devices.2024-02-27View More
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DiaCarta, Inc. ("DiaCarta"), a pioneer in molecular diagnostic test development for cancer and infectious diseases, today announced that it has established a strategic collaboration with OncoAssure Ltd, an Irish medical diagnostics company. The focus of the collaboration is to commercialize OncoAssure's groundbreaking Prostate test which is designed to identify patients with a lower risk of prostate cancer recurrence, guiding decisions on active surveillance or reduced monitoring post-treatment.2024-02-27View More
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Mainz Biomed N.V. (NASDAQ:MYNZ) (¡°Mainz Biomed¡± or the ¡°Company¡±), a leader in molecular genetics diagnostic solutions for early cancer detection, announced today a strategic partnership with TomaLab to launch the Company¡¯s flagship product, ColoAlert® in Italy. TomaLab is one of Italy¡¯s premier biotechnology laboratories and is based in Milan. The partnership signifies a major step forward in enhancing colorectal cancer screening and diagnostics within the Italian healthcare system as it enables the implementation of ColoAlert® into Italy's robust healthcare framework, providing patients with access to a cutting-edge diagnostic solution that combines convenience with clinical excellence.2024-02-26View More
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Researchers at the Washington University in St. Louis and Lund University in Sweden have taken a step closer toward developing a blood test that could be used during an annual doctor¡¯s office visit to help catch cases of Alzheimer¡¯s disease.2024-02-26View More
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Scientific instruments maker Agilent Technologies has promoted Padraig McDonnell to CEO-elect and chief operating officer. He will become president and CEO in May, and will also join the company¡¯s board of directors at that time.2024-02-23View More
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QuidelOrtho announced today that it terminated President and CEO Douglas Bryant, effective immediately.2024-02-23View More
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Veracyte, Inc. (Nasdaq: VCYT) today announced financial results for the fourth quarter and full year ended December 31, 2023.2024-02-23View More
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Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today reported financial results for the quarter and full year ended December 31, 2023.2024-02-23View More
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Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, today announced that the company generated revenue of $647 million for the fourth quarter of 2023 and $2.50 billion for the full year of 2023, both ended Dec. 31, 2023.2024-02-22View More
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Becton Dickinson announced on Wednesday that it has partnered with digital health firm Camtech Health to increase cervical cancer screening in Singapore through self-collection of samples.2024-02-22View More
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From 1 January to 31 December 2023, China¡¯s NMPA accepted a total of 13,260 applications for the first registration, renewal of registration and change of registration of medical devices in accordance with its duties, an increase of 25.4% compared with 2022.2024-02-21View More
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A new UK industry body designed to help medical device regulators navigate the new legal landscape of a post-Brexit Britain has launched with backing from 11 companies.2024-02-21View More
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The US Food and Drug Administration on Tuesday issued a letter to medical device manufacturers and sponsors of device studies warning them to independently verify performance test results before submitting them to the agency due to concerns about fraudulent results.2024-02-21View More
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If Chinese chemiluminescence would eventually replace imported products completely, it must ensure the accuracy and reliability of the test results. In addition to the improvement of equipment system and methodology, the accuracy of results will involve two very core competitions in the future.2024-02-20View More
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Freenome said on Thursday that it raised $254 million in funding from existing and new investors to advance its pipeline of single- and multi-cancer early detection tests.2024-02-20View More
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