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CardiacAssist wins 510(k) for TandemLung

March 15, 2016 By Fink Densford Leave a Comment

CardiacAssist said today it won FDA 510(k) clearance for its TandemLung oxygenator designed to operate as an artificial lung by infusing oxygen and removing carbon dioxide from the blood. The Pittsburgh, Penn.-based company said the TandemLung is designed so it can be used along with its TandemHeart blood pump, and combined the devices “represent a leap […]

Filed Under: 510(k), Food & Drug Administration (FDA), Regulatory/Compliance, Respiratory Tagged With: CardiacAssist Inc.

ABT unveils OTC glucose meter | Regulatory news for the week of April 20, 2015

April 21, 2015 By MassDevice Leave a Comment

Abbott unveils over-the-counter glucose meter

April 17, 2015 by Val Kennedy

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance, Respiratory Tagged With: Abbott, AcuFocus Inc., CardiacAssist Inc., Conventus Orthopaedics

Cardiac Assist wins CE Mark for emergency cannula

April 20, 2015 By Mark Hollmer Leave a Comment

Cardiac Assist wins CE Mark for emergency cannula

CardiacAssist last week said it nailed down CE Mark approval in the European Union for a cannula designed to both drain and re-infuse blood during life support procedures.

Filed Under: News Well, Regulatory/Compliance, Respiratory, Structural Heart Tagged With: CardiacAssist Inc., CE Mark

Bard wins FDA panel date for Lutonix balloon | Regulatory news for the week of May 26, 2014

May 27, 2014 By MassDevice Leave a Comment

Bard wins FDA panel date for Lutonix balloon

May 20, 2014 by Brad Perriello

Bard wins FDA panel date for Lutonix balloon

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: C.R. Bard, CardiacAssist Inc., Fisher & Paykel Healthcare

FDA warns CardiacAssist on unreported patient death

May 22, 2014 By Arezu Sarvestani Leave a Comment

FDA warns Cardiac Assist on unreported patient death

Pennsylvania-based CardiacAssist landed in the FDA’s cross hairs this month after agency inspectors found that the company failed to file a report after learning of a patient death.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance, Structural Heart Tagged With: CardiacAssist Inc., Warning Letter

CardiacAssist receives FDA IDE approval for TandemHeart pivotal trial

December 19, 2012 By MassDevice staff Leave a Comment

CardiacAssist logo

Pittsburgh-based medical device maker CardiacAssist received Investigational Device Exemption approval from the FDA to begin a pivotal clinical study of its TandemHeart circulatory support system.

The TandemHeart to Reduce Infarct Size trial will evaluate the effectiveness of ventricular unloading on the reduction of infarct size for patients with severe heart attack, according to the press release.

Filed Under: Food & Drug Administration (FDA), News Well, Structural Heart Tagged With: CardiacAssist Inc., Clinical Trials

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