August 7, 2025 — DeepHealth, Inc., a wholly-owned subsidiary of RadNet, Inc., announced it has received FDA 510(k) clearance for TechLive – a remote scanning solution enabling centralized operation and supervision of MR, CT, PET/CT, and ultrasound procedures. Amid tech labor shortages and inflationary wage pressure, TechLive empowers technologists to scan for multiple locations, enables improved operational efficiency, extends center operating hours and enhances access to complex procedures.

Aug. 7, 2025 — Carebot, a technology company specializing in the development of artificial intelligence for X-ray image analysis, is developing a next-generation AI assistant for musculoskeletal (MSK) X-rays. By integrating large language models (LLMs) into their solution, the company aims to significantly speed up and streamline fracture reporting.

Aug. 5, 2025 — New Lantern has announced the launch of two specialized viewer modes: the Mammography Viewer Mode and PET/CT Viewer Mode. These solutions address bottlenecks in breast imaging and breast and PET/CT imaging, delivering sub-second load times and AI-powered automation, called Curie, to all imaging modalities. With these additions, the company now serves the full spectrum of imaging modalities, delivering a complete AI radiology solution that eliminates the need for radiologists to navigate multiple platforms.

Aug. 1, 2025 — The American Roentgen Ray Society’s American Journal of Roentgenology (AJR) has published a clinically practical model for early pathologic complete response (pCR) prediction in patients undergoing neoadjuvant chemoimmunotherapy (NACI) for triple-negative breast cancer (TNBC).

July 31, 2025 —Hyperfine, Inc. has announced the enrollment of the first patients in the PRIME (Portable Rapid Imaging for Medical Emergencies) study. This study aims to evaluate the potential of AI-powered portable MRI technology to transform triage in the emergency department (ED) setting.

Reshaping Diagnostic Pathways

Imaging is a crucial diagnostic, treatment and monitoring tool in modern medicine. From diagnosis to disease management, having access to timely, accurate images can help clinicians and patients evaluate disease progression or healing, and inform treatment plans.

Access to imaging is not without its challenges, though.

July 30, 2025 — Fujifilm Healthcare Americas Corp., a leading provider of diagnostic and enterprise imaging solutions, has announced the U.S. launch of the FDR Go iQ, a portable digital radiography (DR) solution built for hospitals and ambulatory surgery centers. Equipped with intuitive touchscreen controls and a display at the tube head, as well as convenient built-in smart charging, technologists can acquire x-ray room image quality at the patient bedside.

July 29, 2025 — A new technology that harnesses AI to analyze mammograms and improve the accuracy of predicting a woman’s personalized five-year risk of developing breast cancer has received Breakthrough Device designation from the Food and Drug Administration (FDA). Developed by researchers at Washington University School of Medicine in St. Louis, the software has been licensed to Prognosia Inc., a WashU startup company.

July 23, 2025 — Royal Philips recently announced that the latest Philips UroNav version for image-guided navigation for prostate cancer care was granted FDA 510(k) clearance. The system includes a new advanced annotation1 workflow that supports clinicians during focal therapy procedures, helping deliver more precise, minimally invasive care.

July 23, 2025 — Elekta has received U.S. Food and Drug Administration (FDA) 510(k) clearance to include refractory, intractable mesial temporal lobe epilepsy (MTLE) in adults among its indications for use with the company’s Leksell Gamma Knife radiosurgery system.

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