Collaboration tackles complex challenges using data science to improve decision-making in cancer care.
Light field technology is illuminating a path to a deeper understanding of patient anatomy, surgeon methodology, and surgical environments. Traditionally, spine surgery navigation has depended on surgeons combining pre-operative imaging with intra-operative anatomy to execute their treatment plans. However, with light field technology and depth sensors, these technologies digitize the entire operative field, merging it seamlessly with preoperative imaging, effectively bridging the gap between unseen and visible physical anatomy of the spine. This provides surgeons with a three-dimensional anatomical view that exceeds what the naked eye can discern.
Diagnostic manufacturers and pharmaceutical sponsors with therapeutics that rely on biomarker identification or companion diagnostics should adjust their commercialization and partnership strategies to fit the new regulatory environment.
North Carolina healthcare provider supplies clinicians with immediate, on-site access to 3D-printed anatomic models and support through Ricoh Managed Services.
FDA has finalized its landmark proposed rule that will amend the definition of “in vitro diagnostic (IVD) products” in 21 CFR 809.3 to make explicit that IVDs are medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA), “including when the manufacturer of the IVD is a laboratory.”
San Diego-based medical tech company, Cue Health, announced Monday that it is laying off its entire staff. Similar industry reports indicate a complete shuttering of operations.
Researchers have developed a new machine-learning model that can precisely make prognosis predictions for patients with osteosarcoma, based on the density of viable tumor cells post-treatment.
Traditional screening tests suffer from a range of challenges. From logistical barriers to concerns regarding accuracy and reliability, achieving accurate diagnosis is frequently arduous. Imagine a revolutionary approach where early disease screening becomes as simple as collecting a breath sample. Thanks to cutting-edge sensor technology and advanced artificial intelligence, this vision is now on the brink of realization.
In February, Hologic received FDA clearance for its Genius Digital Diagnostics System, which combines advanced imaging with AI-assisted review for cervical cancer screening. We spoke with Mike Quick, who led the development of the technology, and Dr. Hans Ikenberg, director of one of the first labs to work with the system.
If adopted, companies would have additional time—from 2027 to 2029, depending on the type of device—to gain approval under EU IVDR.
