Minneapolis-based Advanced Circulatory wins an FDA expert panel nod for its ResQCPR resuscitation system.
The FDA's Circulatory System Devices Advisory Panel voted this month to recommend approval for Advanced Circulatory's ResQCPR system for use during emergency CPR to help increase survival and minimize brain damage.
FDA experts will meet May 6 to discuss potential approval of Advanced Circulatory Systems' ResQCPR resuscitation systems.
Minnesota medical device maker Advanced Circulatory Systems won a panel date with the FDA to review a PMA bid for its ResQCPR resuscitation systems.
A federal judge tosses another lawsuit filed against Philips Healthcare by AED rival Zoll Medical.
The FDA warns on new issues with GE Healthcare's neonatal warmers and resuscitation systems, which were recalled in October 2013.
Federal healthcare regulators put their highest-risk Class I label on a new warning issued over GE Healthcare's (NYSE:GE) Giraffe and Panda neonatal infant warmers and resuscitation systems.
Zoll Medical wins 510(k) clearance for its AED Plus CPR-assist technology.
Asahi Kasei (TYO:3407) subsidiary Zoll Medical won 510(k) clearance from the FDA for its fully-automated AED Plus device, which improves on the former semi-automatic model.
The new automated external defibrillator allows emergency responders to pre-program a shock instead of pushing the "shock" button.
Healthcare giant GE recalls a resuscitation upgrade kit installed in certain infant warmers over concerns that mix-ups in labeling could lead to significant harm.
The FDA gave Class I status to GE Healthcare's (NYSE:GE) recall of upgrade kits for some infant warmers over concerns that mislabeling in the kits may result in neonatal patients getting the wrong oxygen concentrations.