Newstem Ltd. filed a presubmission to the U.S. FDA for a de novo request and an in vitro diagnostic device with the EMA for its Newstem software diagnostic device (NSDD). The bioinformatics-based platform is a personalized diagnostic to inform oncologists about the presence of mutations in tumors and predict a patients’ resistance to chemotherapy treatments. The technology utilizes specialized stem cells (haploid cells) that carry just one set of chromosomes.

Telix Pharmaceuticals Ltd. has in-licensed Eli Lilly and Co.’s olaratumab antibody, agreeing to pay $5 million up front for exclusive worldwide rights to develop and commercialize radiolabeled forms of the antibody for the diagnosis and treatment of human cancers.

Merit Medical Systems Inc. received FDA 510(k) clearance for the Scout Bx delivery system, which enables the placement during stereotactic and MRI-guided biopsy of a reflector to guide breast surgery. The delivery system works with the company’s Scout reflector, a wire-free radar localization device.

C2i Genomics Inc. reported the formal launch of its C2inform minimal residual disease diagnostic across Europe, after obtaining CE marking for the cancer test. The Cambridge, Mass.-based company also has completed several clinical trials it ran with research partners to validate the technology and will be presenting data in different cancers at the American Association for Cancer Research in New Orleans, April 8-13.

Truscreen Group Ltd. completed its largest clinical trial to date that showed its cervical cancer screening device surpassed liquid-based cytology (LBC) screening in 15,651 women across 64 hospitals in nine provinces in China over three years.

Pangea Biomed Ltd. picked up $7 million in seed financing to fast-track development of its multicancer, multitherapy response predictor Enlight. The platform combines machine learning and RNA sequencing to map tumor molecular signatures and predict how different cancer types will respond to oncology drugs. Pangea said instead of using transcriptomic data, it is utilizing ‘unsupervised’ AI techniques that harvest information about gene interactions.

The U.S. CMS has suspended the effective date of the radiation oncology (RO) model for bundled care under the Medicare outpatient prospective payment system. The development stems from congressional legislation that pushed the start date back until next year, giving stakeholders who are opposed to the program more time to press their case with Congress and the agency.

Elekta AB signed a commercial agreement with GE Healthcare Co. Ltd. to expand hospital access to radiotherapy. Marlborough, Mass.-based GE Healthcare said it will combine its precision imaging solutions with Elekta’s radiation therapy portfolio to provide hospitals worldwide with a more comprehensive oncology offering.

A 2,000-patient U.K. study has been set up to generate real-world evidence of the value of using AI technology to detect bowel polyps (adenomas) during colonoscopy procedures. The aim is to show whether Medtronic plc’s GI Genius system improves the detection of polyps when deployed in both expert centers and non-specialist units, in the routine diagnostic screening of patients referred from primary care or through the national fecal immunochemical testing program.

With FDA clearance of its Endoscreener that uses artificial intelligence (AI) to detect polyps during coloscopy procedures, Wision AI Ltd. is expanding its product portfolio to include colorectal histopathology tools.