The U.S. FDA has given Resapp Health Ltd. the green light for its 510(k) Sleepcheckrx app to detect moderate to severe sleep apnea in adults as a prescription-only software-as-a-medical device. The FDA cleared the app as a class II medical device. Brisbane, Australia-based Resapp submitted the 510(k) premarket notification to the FDA in November 2021 for Sleepcheckrx for at-home sleep apnea screening.

Clarity Pharmaceuticals Ltd. is progressing three of its targeted copper theranostics through the clinic that are based on its sarcophagine technology that securely holds copper isotopes inside a cage-like structure, called a chelator. The SAR technology allows a unique pairing of copper isotopes, copper-64  and copper-67, for both cancer diagnosis and therapy.

Oxford University has opened the doors to its new Pandemic Sciences Institute, a £100 million (US$119.5 million) initiative to build on the research and experience of COVID-19, to counter future pandemic threats.

Immunovia AB is progressing a study evaluating its Immray Pancan-d blood test for the early detection of pancreatic cancer in patients with new onset type 2 diabetes. Studies have found that type 2 diabetes is a major risk factor for developing pancreatic cancer, and the screening of molecular biomarkers may help patients access treatment before they develop symptoms. The company’s lab-developed test (LDT) measures nine serum biomarkers that, when combined in an algorithm, can detect pancreatic ductal adenocarcinoma.

The University of Central Florida (UCF) and Orlando Health are testing new medical technology designed to identify blood clots more quickly in surgery. The monitoring device consists of a small optical fiber that uses red blood cells to track the process of blood coagulation in patients so doctors can watch for life threatening blood clot formation.

Ceros Capital Markets and Peregrine Ventures evidently liked what they heard about Cordio Medical Ltd.’s Hearo voice app that can detect deterioration in patients with congestive heart failure (CHF), leading them to invest $18 million in the company’s latest venture funding round.

Patent disputes between developers of medical software might not have kept pace with the rate of disputes over in vitro diagnostic patents, but Alivecor Inc. and Apple Inc. are doing their share to keep software patents in the news. In the latest development, Mountain View, Calif.-based Alivecor reported that it won an initial determination of infringement of one of its patents by Apple Inc., of Cupertino, Calif., which could lead to an exclusion order for Apple watches if the case ultimately goes Alivecor’s way.

Investors ate up the opportunity to be part of Gemelli Biotech Corp.’s series A funding round, which raised $19 million to support the company’s growth and expand access to its diagnostic tests for gastrointestinal (GI) diseases. Blue Ox Healthcare Partners led the round with founding investor Cedars-Sinai and support from Carolina Angel Network, Cerracap Ventures and several family offices.

Prognomiq Inc. secured access to 800,000 anonymized biological samples for analysis and detection of dynamic cancer biomarkers as part of a new partnership struck with Kahn-Sagol-Maccabi (KSM), the research and innovation center of Maccabi Healthcare Services, Israel’s largest health maintenance organization. The partnership will enable the creation of a biomarker platform the organizations hope will facilitate early diagnosis and improved outcomes for cancer patients using Prognomiq’s multiomics platform.

Biocartis Group NV received CE-marking of its Idylla Gene Fusion lung cancer biomarker test. The automated panel is designed to detect chromosomal translocations that generate fusion genes and cause non-small-lung cancer (NSCLC). Mechelen, Belgium-based diagnostics company Biocartis recently reported results from a study that found the assay enables rapid screening with quicker turnaround and lower tissue requirements compared to standard methods.