Category: ResuscitationSyndicate content

FDA panel votes 'yes' on Advanced Circulatory's new CPR tech

May 16, 2014 by Arezu Sarvestani

Minneapolis-based Advanced Circulatory wins an FDA expert panel nod for its ResQCPR resuscitation system.

FDA panel votes 'yes' on Advanced Circulatory's ResQCPR

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.

Advanced Circulatory Systems lands a date with the FDA

April 21, 2014 by Arezu Sarvestani

FDA experts will meet May 6 to discuss potential approval of Advanced Circulatory Systems' ResQCPR resuscitation systems.

Advanced Circulatory Systems lands a date with the FDA

Minnesota medical device maker Advanced Circulatory Systems won a panel date with the FDA to review a PMA bid for its ResQCPR resuscitation systems.

Judge tosses latest Zoll suit against Philips

April 15, 2014 by Brad Perriello

A federal judge tosses another lawsuit filed against Philips Healthcare by AED rival Zoll Medical.

Judge tosses latest Zoll suit against Philips

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Another Class I recall for GE Healthcare

March 6, 2014 by Arezu Sarvestani

The FDA warns on new issues with GE Healthcare's neonatal warmers and resuscitation systems, which were recalled in October 2013.

Another Class I recall for GE Healthcare neonatal systems

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 lands FDA clearance for automated external defibrillator

February 8, 2013 by MassDevice staff

Zoll Medical wins 510(k) clearance for its AED Plus CPR-assist technology.

Zoll

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.

GE Healthcare announces Class I recall of infant resuscitation kits

February 1, 2013 by MassDevice staff

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.

GE Healthcare logo

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.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Built on an AdaptiveTheme using Drupal by Michael Knapp  mknapp