Denver-based Arcscan Inc. gained Chinese approval of its computer-controlled, ultra-high frequency ultrasound diagnostic imaging solution for myopia called Insight 100, expanding its reach beyond the U.S. and Europe.

The Surveillance Heartcare Outcomes Registry trial demonstrated that Caredx Inc.’s Heartcare test identifies acute cellular rejection in heart transplant patients better than donor-derived cell-free DNA (dd-cfDNA) alone, while reducing biopsies and improving clinical outcomes. Heartcare combines two non-invasive tests, dd-cfDNA and Allomap Heart gene-expression profiling.

The U.S. FDA issued a May 9 warning letter to Cue Health Inc., of San Diego, following what may have been a routine inspection, but the inspection disclosed that the company had made changes to a COVID test that was granted market access via the emergency use authorization program.

Medtronic plc teamed up with healthtech software company Modernizing Medicine Inc. (ModMed) to make colonoscopy procedures more efficient by integrating data generated from Medtronic’s GI Genius system into ModMed's gGastro EHR software to enhance endoscopic care.

The U.S. FDA’s final rule for lab-developed tests was a long time in coming even if the agency shorted the public comment period for the draft rule, and the final rule makes several major concessions about circumstances in which the agency would exercise enforcement discretion.

Angle plc recently signed an agreement with Astrazeneca plc to develop an androgen receptor (AR) detection assay for use in prostate cancer studies, based on its Parsortix system, which captures and harvest circulating tumor cells for subsequent analysis.

Heartflow Inc. reported exceptional results in a study published in the Journal of Vascular Surgery that revealed coronary computed tomography angiography with fractional flow reserve care reduced mortality by more than 60% at five years in patients with peripheral arterial disease undergoing major vascular surgery, far surpassing the current standard of care.

Researchers have developed a new blood collection device inspired by the behavior of a leech which attaches itself to a host, penetrates their skin with its teeth and swallows to create negative pressure drawing blood.

Researchers from Peptidream Inc. presented preclinical characterization of novel carbonic anhydrase IX (CAIX)-targeting radiopeptides, [64Cu]PD-32766 and [177Lu]PD-32766, being developed for the diagnosis and treatment of clear cell renal cell carcinoma (ccRCC), respectively.