In the News
Approvals
Biotronik Inc., Lake Oswego, Ore., for the Evia pacemaker, which incorporates patient and device monitoring. Its data output may be transmitted to the physician by cellular phone.
St. Jude Medical Inc., St. Paul, Minn., for the Unity cardiac resynchronization and Fortify implantable cardioverter defibrillators, designed for smaller implantation incisions and faster charging cycles.
Immucor Inc., Norcross, Ga., for the Neo, an automated blood type-and-screen instrument intended for use in high-volume laboratories.
Xlumena, Mountain View, Calif., for the Navix endoscope, designed to enable secure access, dilation and guidewire delivery during pseudocyst and abscess drainage procedures.
Asthmatx Inc., Sunnyvale, Calif., for the Alair bronchial thermoplasty system, cleared for treating severe asthma that is not well controlled by inhaled corticosteroids and longer-acting drugs. Alair is intended for patients ages 18 and older.
Digirad Corp., Poway, Calif., for the Ergo portable camera, designed for nuclear studies throughout the hospital.
Medtronic Inc., Minneapolis, for the PoleStar N30 MRI imaging system, used to achieve maximum tumor resection while avoiding critical areas during brain surgery.
NDS Surgical Imaging, San Jose, Calif., for the ZeroWire Duo, a wireless, high-definition video system designed for minimally invasive surgery, gastro-intestinal and interventional suites.
Lannett Co. Inc., Philadelphia, for Ondansetron injection USP, 2 mg/ml, in multiuse vials, indicated to treat nausea and vomiting in post-operative and chemotherapy patients.
Cambridge Heart Inc., Tewksbury, Mass., for the Microvolt T-Wave Alternans module, a cardiac stress-test platform designed to work with the A-Stress system.
This article first appeared in the June 2010 issue of Materials Management in Health Care.
To respond to this article, please click here.
