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Brian Dunham

Increasingly burdensome regulatory policy can be blamed for driving research and development of new medical devices outside the U.S., according to the author of an Oct. 12 Competitive Enterprise Institute essay. The piece called for maintaining the 510(k) process and increasing oversight of the FDA.

Biotronik has released an online Quick View report to provide physicians with information on patients using the company's home monitoring technology.

Bioheart stated it will begin a U.S. clinical program utilizing adipose cells for congestive heart failure patients. In what it is calling the Angel trial, the Sunrise, Fla.-based company will use data from a Phase I/II trial in Mexico and clinical studies to apply to the FDA to start a Phase I study in the U.S.

A telehealth tool may help manage care and cut expenses in the treatment for chronically ill Medicare beneficiaries, according to a recent study that looked at two clinics in the Northwest that were exposed to the intervention.

Researchers have found that patients who receive cardiac electrophysiological devices (CIEDs) are at greater risk of contracting an infection sometime during the lifespan of the device today compared with previous years, according to a 16-year retrospective study published Aug. 30 in the Journal of American College of Cardiology.

As automated contrast injectors are increasingly utilized in cardiology departments, administrators are establishing protocols to lessen the incidence of contrast-associated adverse events, as well as improving the bottom line. Both goals, it seems, are interrelated.

IntriCon has received FDA 510(k) clearance for the first-generation wireless cardiac diagnostic monitoring device, which offers wireless transmission of patient data so physicians can continuously monitor cardiac events remotely.

The Institute of Medicine's (IOM) recent recommendation to eliminate the 510(k) clearance process for medical devices has prompted a sharp exchange between its leaders and medical device manufacturers.

The FDA proposed requiring the filing of a premarket approval application or a notice of product development protocol for the Class III preamendments device implantable pacemaker pulse generator, according to a proposal published July 27 in the Federal Register.

Real-time pharmacy surveillance of high-alert medications increased the likelihood of intercepting medication errors, according to a six-month study published in the July issue of the Joint Commission Journal on Quality and Patient Safety.