Roche Diagnostics CEO Matthew Sause tells Medtech Insight about how the technology addresses the pricing challenges for mid- and low-throughput customers.
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Q’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.
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.
Urologists at the Cleveland Clinic in Ohio and Abu Dhabi collaborated successfully to perform the first transcontinental robotic-assisted focal therapy for prostate cancer using EDAP’s Focal One HIFU robotic system. The procedure served as proof of concept for future teleprocedures. EDAP’s CEO Ryan Rhodes told Medtech Insight other hospitals are also showing interest in this type of collaboration.
Members of AdvaMed’s digital health tech board of directors discussed the organization’s efforts to aid the Trump administration and Congress in answering AI policy questions, especially as companies deal with mounting regulatory uncertainty.
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.
