The U.S. FDA drafted a guidance for clinical trials for evaluation of optical imaging (OI) agents. The policy may allow clinical studies to evaluate an OI agent by means of an intrasubject study design, which would save time and money for the sponsor.

Scientists at the University of Aberdeen developed a new scanner that distinguishes breast tumor material from healthy tissue more accurately than current magnetic resonance imaging (MRI) methods.

The FDA’s final rule for lab-developed tests (LDTs) is in litigation, and a district court decision may be shortly in the works.

The routine use of software to interpret the results of lab-developed tests (LDTs) leaves clinical labs in a complicated spot in 2025 thanks in no small part to an ongoing lawsuit over the U.S. FDA’s final rule for LDTs.

Researchers from Weill Cornell University filed for protection of discoveries made from investigations into the mechanisms underlying depression, which revealed that a specific brain network is significantly larger in individuals affected by depression.

The U.S. FDA hasn’t taken up criminal justice as a sideline, but it did just clear Sonio Suspect. Far from a social miscreant, Suspect improves detection of fetal anomalies by 22 points by automatically detecting multiple types of abnormal findings and allows for detection as early as 11 weeks of gestation.

Up to 50% of glaucoma cases have a genetic component, a factor which could significantly change the screening recommendations and monitoring of patients – if they know their risk. Seonix Pty. Ltd. has a vision for making that genetic information easier to obtain and use to guide care with its Sightscore saliva-based test.

The first patenting from Theta Neurotech Inc. sees the company’s co-founders describe their development of a wearable earpiece that uses an electroencephalography technology and machine learning algorithms to alert epilepsy patients 30 to 60 minutes before they have a seizure.

The latest patenting from Canan Dagdeviren seeks protection for their wearable, conformable ultrasound breast patch that enables standardized and reproducible image acquisition over the entire breast with less reliance on operator training and applied transducer compression.

Harrison.ai raised AU$179 million (US$112 million) in a series C round to expand its radiology and pathology solutions across the U.S., Europe, the Middle East, Africa and Asia Pacific.