The U.S. FDA’s approval of Telix Pharmaceuticals Ltd.’s kit for preparing prostate-specific membrane antigen-PET imaging for prostate cancer widens the opportunities for patients who live far away from large hospitals. The FDA’s nod for the imaging agent, TLX007-CDx, now branded as Gozellix, has a long shelf life and needs less equipment and preparation compared to some other agents.

Samsung Life Science Fund made its first strategic investment of the year into C2N Diagnostics LLC, underscoring the rising potential of blood-based diagnostics in detecting and monitoring the risk of Alzheimer’s disease for the masses.

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.

Royal Philips NV recently secured EU MDR certification for the remote scanning capabilities on its Radiology Operations Command Center Console. The solution allows radiologists to remotely assist technologists in real-time by controlling scans to acquire images needed for improved diagnostic confidence and patient outcomes.

After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025.

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.

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.

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.

Dongkook Life Science Co. Ltd. (DKLS) priced a ₩18 billion (US$12.5 million) IPO on the Korea Exchange as South Korea’s first med-tech listing of the year.