Targetingone Corp. Ltd.’s new testing kit based on digital polymerase chain reaction (dPCR) techniques has received approval from China’s NMPA. It is the first dCPR-based testing kit to receive the country’s class III medical device registration certificate. The Beijing-based company collaborated with Tsinghua University, several hospitals and the Chinese Center for Disease Control and Prevention (CDC) participated to research and develop the testing kit.

The COVID-19 pandemic has hit supplies and devices across a broad range of categories over the past two years, and the latest addition to the list is the blood collection tube. The FDA announced that this shortage affects all types of blood collection tubes, thus affecting tubes for all uses, not just those used for testing for the SARS-CoV-2 virus.

Acutus Medical Inc. provided highlights of a corporate restructuring along with preliminary unaudited revenues for the fourth quarter and year ended Dec. 31, 2021. The company “will prioritize maximizing console utilization and procedure volume growth in targeted geographic regions as well as a more focused scope of product development initiatives.” The restructuring will include the layoff of more than 50 staff members and reduction of manufacturing costs designed to produce annualized operating expense savings of $23 million to $25 million in 2022.

The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) unveiled a proposal to overhaul its requirements for clinical trials for drugs and devices, just one of several significant regulatory proposals in recent months. One of the proposed changes would be to require more patient engagement in the design of trials, while another feature would allow sponsors to go through the MHRA process and an ethics review in a single application, thus potentially streamlining the up-front work required for these studies.

Clinisys Inc. has signed a deal to buy laboratory information company Horizon Lab Systems LLC and combine Sunquest Information Systems under the Clinisys brand. The resulting group will be one of the world's largest laboratory informatics organizations. Clinisys and Sunquest share the same parent company – Roper Technologies Inc., which trades on the NYSE stock exchange. The addition of Raleigh, N.C.-based Horizon provides Clinisys with expertise in the public health, environmental, water quality, toxicology and agriculture markets.