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.

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.

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.

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.

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.

QuidelOrtho announced today that it terminated President and CEO Douglas Bryant, effective immediately.

Veracyte, Inc. (Nasdaq: VCYT) today announced financial results for the fourth quarter and full year ended December 31, 2023.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today reported financial results for the quarter and full year ended December 31, 2023.

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.

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.

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.

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.

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.

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.

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.