04 November 2024
04 November 2024
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The company has announced that its new IDE will be used to launch a pivotal trial of its treatment for PAD.
NeuroMatch Access uses AI to streamline EEG data analysis and allows for real-time collaboration between neurologists.
The Acclaim CI was granted the breakthrough device designation by the FDA in 2019.
The support is crucial for Medicare beneficiaries to gain access to healthcare innovations soon after FDA approval.
The FDA's final rule of LDTs includes a four-year phaseout to bring IVDs under its regulation, but there are obstacles.
Decentralized and hybrid clinical trials are transforming medical research, offering greater flexibility, improved patient engagement, and faster recruitment.
The companies aim to enhance cancer diagnostics in the region, with plans to expand the assay’s rollout throughout Europe.
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