pacemakers news from FierceHealthcare
NewsBiotronik implants linked with possible physician kickbacks
A federal investigation looking into whether device manufacturer Biotronik used illegal marketing and sales practices to get physicians to use its defibrillators and pacemakers, the New York Times Read more...
Medtronic warns of higher pacemaker failure rates
Medical devicemaker Medtronic has sent out a letter warning doctors that it found a higher rate of failure in its Kappa and Sigma brand pacemakers than it had originally predicted. The company is Read more...
SPOTLIGHT:Cardiologist groups call for closer monitoring of ICD wires
A group of cardiologists has called for closer monitoring of wire leads that connect to defibrillators and pacemakers in the heart in the wake of serious malfunctions and deaths that took place in Read more...
FDA says CT scans can make medical devices malfunction
The FDA has issued a warning that some critical electronic devices may malfunction when patients get CT scans. In fact, CT scans may actually cause some medical devices to shock patients using them, Read more...
FDA to tighten medical device safety regsThe FDA has announced plans to tighten up regulations governing several medical devices, including stents, pacemakers, implantable defibrillators and other medical devices it regulates. The move was prompted, in part, by concerns over last year's massive defibrillator recalls, which concerned more than 200,000 devices. Among other steps, the FDA would like to see devices marked with a unique … Read more...Boston Scientific announces recall, shares dropBoston Scientific said it will recall one of its pacemaker models after an FDA report released last week suggested many of the units will eventually malfunction. The device maker's shares fell seven percent on the news Monday and are down midday Tuesday. CEO Jim Tobin said in a conference call that it may take 18 months to two years to correct problems with the pacemakers and defibrillator lines the company acquired in the Guidant deal this year. He also hinted the recall may not be the … Read more...SPOTLIGHT: Medtronic wins FDA approval for Concerto
CMS mulls reimbursement cuts for cardiac devicesCMS is considering reducing Medicare reimbursements for implantable heart devices, a change that could be a painful hit for specialty hospitals and device makers, if it does in fact go through. The cuts would impact some of the most lucrative heart device categories on the market, including pacemakers, defibrillators and stents. CMS officials say the changes are necessary to eliminate loopholes that specialty hospitals had been exploiting. The agency is weighing reducing payments for … Read more...FDA to monitor heart device safetyThe FDA said it will set up a team of outside medical experts to study the safety of heart devices currently on the market. The decision is a step in a new direction for the agency, which has historically relied on internal advisory panels to review the safety of drugs and medical devices. The announcement comes days before the release of a report by the Heart Rhythm Society, an influential cardiologists group, which is expected to recommend major changes in the way safety issues are … Read more...Panel chastises Guidant over recallAn independent review panel sharply criticized Guidant for its past handling of patient-safety issues. The panel said the company's response to evidence of serious defects involving its pacemakers and defibrillators was inappropriate. Guidant executives learned of the problems three years ago, but chose not to release the information. The group's report finds the company relied on engineers to make decisions about the release of safety information rather than turning to medical experts. … Read more... | Press ReleasesPennsylvania Heart Rhythm Center Studies Pacemaker Implantation in the Extreme ElderlyThe Heart Rhythm Center of Lebanon Cardiology Associates and The Good Samaritan Hospital are proud to present their outcomes of pacemaker implantation in the extreme elderly at the American Heart Read more >> St. Jude Medical Announces European Approval of Accent MRI Pacemaker SystemNew innovative pacing system designed and tested for safe MRI performance ST. PAUL, Minn.--(BUSINESS WIRE)-- St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that Read more >> Mayo Clinic Women’s HealthSource, February 2011: Devices Help Hearts Keep Pace; Genetic Counselors Offer Information and SROCHESTER, Minn.--(BUSINESS WIRE)-- Here are highlights from the February issue of Mayo Clinic Women’s HealthSource. You may cite this publication as often as you wish. Mayo Clinic Women’s Read more >> St. Jude Medical Earns CE Mark Approval for Manufacturing in MalaysiaST. PAUL, Minn.--(BUSINESS WIRE)-- St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that the company’s new manufacturing facility in Penang Island, Malaysia has Read more >> BIOTRONIK Launches Its New ProMRI® Pacing System PortfolioBIOTRONIK ProMRI® pacing system portfolio gives patients more access to MRI scanning and physicians more options with single and dual chamber pacemaker systems BERLIN & NICE, France--(BUSINESS Read more >> |
