Grail announced it will enroll about 6,200 people in an interventional, multi-center study evaluating its multi-cancer early-detection blood test. This is the first time health care providers will use this test to help guide patient care.
Grail Inc. is moving closer to its goal of developing a liquid biopsy test that can detect cancer early and help clinicians identify more appropriate treatments faster.
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The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.
Cambridge-based startup Mursla Bio's liquid biopsy test EvoLiver uses extracellular vesicles to detect hepatocellular carcinoma (HCC) in high-risk cirrhotic patients. Medtech Insight sat down with with Mursla Bio CEO Pierre Arsène.
OneCell Diagnostics, the Mumbai-based startup backed with $16m in series A funding, is rebranding to 1Cell.Ai to represent the firm's focus on combining deep science with AI-powered capabilities.
Biotech and pharma are increasingly clear about one thing: They need diagnostics. But with prices suppressed, how have diagnostics companies proven their utility without going under?
The US FDA continues to issue early alerts as part of its communications pilot aimed at improving how the agency manages recalls. This time, the agency is notifying users about two separate intravascular catheters.
The US Medicare agency will hold three public meetings in June and July addressing tremor treatment devices and clinical diagnostic lab tests. The first meeting on June 25 will focus on endpoints for Parkinson’s device trials, while subsequent meetings will address payment rates and codes for laboratory tests.
ChestView, Gleamer’s newly FDA-cleared solution, is designed for chest X-ray interpretation and is the latest addition to its Gleamer Copilot suite. ChestView, which operates as a computer-aided detection system that can simultaneously detect multiple pathologies on images to support radiologists, is being rolled out in the US.
