Two French startups, Gleamer SAS and Azmed SAS, received clearance from the U.S. FDA for their AI-powered tools for chest X-rays. They join an increasing number of companies developing software tools to help clinicians detect a range of abnormalities on images, enhancing diagnostic accuracy, reducing delays and improving patient outcomes.

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.

Histoindex Pte Ltd. launched its laboratory-developed test for metabolic dysfunction-associated steatohepatitis (MASH), Fibrosight, in the U.S. as the company’s first in a suite of next-generation digital pathology solutions.

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.

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.

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.

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.