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.

Cytovale Inc. has posted a feverish run of wins lately. The company gained U.S. FDA clearance for its Intellisep rapid test for sepsis in January 2023, raised $84 million in a series C in November and just published results showing the test has negative predictive value of 97.5%.

Dynamic Therapeutics Ltd. is looking to commercialize its U-Rhythm technology which it hopes will transform the way hormones are measured. U-Rhythm, a portable device which collects biochemical samples from the patient throughout the day, will significantly change the diagnosis and treatment of many diseases, Stafford Lightman, co-founder of Dynamic Therapeutics told BioWorld.

Quest Diagnostics Inc. and Pathai Inc. established a forward-looking deal with multiple components and room for growth. The collaboration includes Quest’s acquisition of Pathai Diagnostics – the division that provides anatomic and digital pathology laboratory services – and licensing of Pathai’s Aisight digital pathology image management system. The companies also said they may work together on development of Pathai’s algorithm products and that Quest will be a preferred provider for Pathai’s biopharmaceutical clinical laboratory services.

In what represents its first patenting, PBSF Inc. filed for protection of brain monitoring and neuroprotection strategies for infants at high risk on a large scale.