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Mayo Clinic's main calling will always be treating patients, but, in surprisingly short order, it has become a player in a brand-new business -- medical devices.
An expert panel commissioned last summer by the Guidant Corporation to review its handling of heart device flaws said yesterday that the company had systematically failed to fully assess patient safety in deciding whether to publicize product failures.
A panel of outside experts faulted Guidant Corp.'s Indianapolis corporate brass for hands-off management of its embattled Minnesota-based cardiac rhythm division, which was criticized last year for not telling doctors about defects in some of the heart devices it makes.
In a decision that could have long-term implications for Boston Scientific Corp. and its rival heart device makers, Medicare decided yesterday to pay for a test made by a small Bedford company that could limit the number of patients who receive implantable defibrillators.
The pocket-watch-sized device is billed as "a pacemaker for the brain," the newest cutting-edge treatment for as many as 4 million adults whose severe depression is not relieved by psychotherapy, drugs or even shock treatments.
Institutional Shareholder Services (ISS), an independent proxy advisory firm, has recommended that shareholders of Boston Scientific and Guidant vote in favor of the proposed combination of their two companies at each company's special meeting of shareholders, to be held on March 31.
AdvaMed has released a proposal for Pulse Generator Product Performance Reports, designed to improve communications between the manufacturers of cardiac rhythm management devices and patients, providers, and the public.
Arbios Systems, a biomedical device and cell therapy company, has announced that the FDA has allowed the expansion of the number of clinical sites and increased the allowable number of patients in the company's IDE feasibility trial for the SEPET liver assist device.
Antares Pharma, Inc. today announced that total revenues for the quarter ended December 31, 2005 increased 3% to approximately $734,000 from approximately $716,000 for the same quarter in 2004.