Organovo (PINK:ONVO) said earlier this week that Taylor Crouch has been appointed as CEO, replacing Keith Murphy who is stepping away from the company. The changes are slated to go into effect on April 21. Prior to being tapped for the corner office, Crouch operated as CEO of investigative clinical research company eStudySite, the San Diego, […]
Defibtech lands FDA clearance for defibrillator
Defibtech landed FDA clearance for its Lifeline AUTO automatic external defibrillator, designed to revive victims of sudden cardiac arrest.
The Lifeline AUTO has a step-by step audio intruction, describing how to apply the defibrillating pads to the victim and when to begin CPR, according to a press release.
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Defibtech recalls certain defibrillators
Defibtech LLC initiated a global recall for two of its semi-automatic external defibrillators.
The recall notice, which affects 65,885 AEDs distributed in the United States, applies to AEDs marketed under the Lifeline AED and ReviveR AED brands, the company said today.
The FDA classified the recall as Class I because it believes the products’ possible malfunction could cause serious injury or death.
FDA to defib makers: Fix the problems with AEDs
The Food & Drug Administration today announced a program for improving the safety and efficacy of automated external defibrillators.
The federal watchdog agency said it’s received 28,000 reports of AED failures in the last five years, yet 300,000 Americans could benefit from treatment from the devices every year.
AEDs are designed to treat cardiac arrest and both diagnose and treat abnormal heart rhythms. While some external defibrillators and intended for medical professionals, AEDs are turning up in homes and public locations with simpler designs.
Defibtech recalls defibrillator batteries
Defibtech LLC commenced a voluntary recall of battery packs for two of its automated external defibrillators.
The recall applies to 5,418 of the company’s DBP-2800 battery packs for its Lifeline AED and ReviveR AEDTM semi-automatic external defibrillators shipped prior to June 4, 2007.
AEDs powered by the affected battery packs had the tendency to falsely detect an error condition and subsequently canceled defibrillation therapy.
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