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- Abiomed issues recall of Automated Impella Controllers over purge cassette detection issueAbiomed has announced a recall of its Automated Impella Controllers after identifying failures in the purge cassette recognition system, which could lead to prolonged delays in mechanical circulato…
- Grail's Galleri blood test receives positive FDA advisory panel vote, moving closer to approvalGrail's multi‑cancer blood test Galleri earned a favorable recommendation from the FDA's medical devices advisory committee, bringing the test one step nearer to U.S. market clearance. The panel v…Fierce Biotech · 1mo agoRegulatoryPositive