Discovery MR750, MRI recall, GE, FDA recall

GE Healthcare initiated a voluntary field corrective action for all of its magnetic resonance imaging (MRI) systems with superconducting magnets that were manufactured from 1985 through today. The U.S. Food and Drug Administration (FDA) classified it as a Class 1 product recall Feb. 18. 

Biotronik announced the completion of enrollment in the BIOSOLVE-II trial — a clinical study investigating the safety and performance of DREAMS (DRug Eluting Absorbable Metal Scaffold).

Three out of five healthcare IT professionals believe that government mandates are having a negative effect on their industry, according to a study conducted by Peak 10, a national information technology (IT) infrastructure and cloud services provider. The majority (94 percent) also noted that complying with regulations influences IT strategy and decision-making. With rare exception, respondents claimed they lack the expertise necessary to navigate the maze of government regulations.

Lutonix, drug eluting balloon, drug coated balloon
Medtronic, In.Pact Admiral DEB, drug coated balloon, drug eluting balloon

Drug-eluting balloons (DEBs) have been one of the long-awaited new transcatheter technologies to help reduce high restenosis rates in peripheral artery disease (PAD). The U.S. Food and Drug Administration (FDA) cleared C. R. Bard’s Lutonix 035 DEB in November 2014 and Medtronic’s In.Pact Admiral DEB in January 2015. Both are indicated for use in the superficial femoral and popliteal arteries in the upper leg.

 

At the SPIE Medical Imaging Conference,  ContextVision exhibited results from research conducted in collaboration with Texas Instruments and High Performance Consulting on 3-D adaptive filtering for improved image quality on portable medical devices. Björn Norell, research scientist at ContextVision, presented the findings.

Calgary Scientific Inc. announced the release of ResolutionMD 5.0, which offers better access to health information, supports increased teamwork and enhances communication among practitioners and patients.

Looking to “bypass the ordinary,” during last week’s episode titled: “The Bed's Too Big Without You,” the Grey’s Anatomy team at Seattle Grace Hospital was challenged with treating a radical tumor in the chest. After printing a 3-D model of the surgical area, Dr. Alex Karev commented that the best course of action to access the chest and successfully remove the mass would involve “the McGinn technique.”

iRhythm, ZIO Service, arrhythmia detection, wearable, Holter monitors

iRhythm Technologies Inc. announced the study, “Cost Analysis and Clinical Outcomes of Ambulatory Care Monitoring in Medicare Patients,” was published in the Journal of Health Economics and Outcomes Research. The study assessed the costs incurred in the diagnosis, additional monitoring and following clinical events after the initial use of the Holter monitor among Medicare patients with arrhythmia.
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