Category: Imaging
Imaging
A new imaging method could give physicians better tools to determine which patients would benefit from receiving implantable cardiac defibrillators.
MASSDEVICE ON CALL — A new imaging tool could help cardiologists better determine which patients are at the highest risk of sudden cardiac arrest and would most likely benefit from receiving an implanted cardioverter defibrillator, according to researchers at the University of Buffalo.
The researchers reported the findings of the UB Parapet study, touted as the largest PET study imaging study ever done on cardiac arrest, at this year's Heart Rhythm Society meeting.
By Stewart Eisenhart, Emergo Group
The U.S. Food & Drug Administration is planning new premarket notification requirements for manufacturers of X-ray imaging systems used on pediatric patients.
The FDA is proposing new guidelines for manufacturers of X-ray imaging devices for pediatric cases, saying device makers who can't prove their products are safe for kids should label them as such.
MASSDEVICE ON CALL — The FDA launched a push to reduce children's exposure to unnecessary radiation from X-ray imaging procedures, saying it wants manufacturers to take more responsibility for ensuring their devices are safe for kids.
The federal watchdog agency said it's issuing draft guidance "recommending that manufacturers design new X-ray imaging devices with protocols and instructions that address use on pediatric patients," according to a press release.
Shareholders at Johnson & Johnson's annual meeting raise questions about the company's recent recalls.
MASSDEVICE ON CALL — Shareholders at Johnson & Johnson's (NYSE:JNJ) annual meeting had much to say about the company's recent slew of high-profile product quality issues.
6 of the top 10 medical device makers have no definitive environmental stainability goals and the 4 who do may be missing opportunities to take their strategies outward, according to a Green Research report.
MASSDEVICE ON CALL — A look at the top 10 medical device makers found that more than half had little to no environmental initiatives in place.
In a study conducted by Green Research, the companies with stainability initiatives were:
The problems with St. Jude Medical's Riata lead, which the company eventually recalled, could have been caught earlier if not for lax policies and practices at the FDA, according to Minneapolis Heart Institute's Dr. Robert Hauser.
MASSDEVICE ON CALL — The problems with St. Jude Medical's (NYSE:STJ) recalled Riata defibrillator leads should have been caught sooner, according to a prominent heart doctor.
Dr. Robert Hauser, of the Minneapolis Heart Institute, in an article for the New England Journal of Medicine, wrote that problems with the leads, which remain active in an estimated 79,000 U.S. patients, went uncovered for too long because of lax post-market surveillance.
