Category: GE Healthcare
Say hello to MassDevice +7, a bite-sized view of the top seven med-tech stories of the week. This latest feature of MassDevice.com's coverage highlights our seven biggest and most influential stories from the week's news to make sure you're up to date on the headlines that continue to shape the medical device industry.
GE Healthcare is pouring $2 billion into a 5-year program to boost its software for healthcare systems and applications.
Medical device giant GE Healthcare (NYSE:GE) announced that it will pour $2 billion into a 5-year software development program to improve its healthcare systems and applications.
GE Healthcare brings its Brivo Plus imaging systems to the U.S. for the 1st time with the FDA’s OK.
GE Healthcare (NYSE:GE) expanded its Brivo Plus C-arm product line with the OEC Brivo Plus, a device used for basic surgical imaging. The new FDA clearance makes the Brivo Plus the 1st in this line of surgical C-arms sold in the States.
The Salt Lake City, Utah-based company touted the device's new features, such as advanced clear intelligence imaging, a user-friendly interface and wireless connection.
GE Healthcare pays an undisclosed amount for Unisyn's ultrasound probe repair business, with Unisys re-branding as Consensys Imaging Service.
GE Healthcare (NYSE:GE) said it acquired the ultrasound probe repair business of Unisyn Medical Technologies for an undisclosed amount. In a separate announcement, Unisyn said it will spin out its diagnostic imaging field service business under the Consensys Imaging Service brand.
GE Healthcare introduces Mavric SL, a novel magnetic resonance imaging technique for joint replacements and implanted devices.
GE Healthcare (NYSE:GE) introduced Mavric SL, a novel magnetic resonance imaging technique intended to more accurately image soft tissue and bone in patients with joint replacements and other implants.
Certain Giraffe Incubators and OmniBed systems may contain a defect that reverts their oxygen and temperature settings back to default when they are shut off or in case of power failure. GE Healthcare warns.
MASSDEVICE ON CALL — GE Healthcare (NYSE:GE) warned that some of its Giraffe Incubator and OmniBed systems contain a faulty component that may pose a risk to patients.
Advocacy group Consumers Union asks the FDA to reclassify a slate of high-risk implantable medical devices to require more stringent clinical testing and regulatory oversight.
MASSDEVICE ON CALL — Consumer advocacy group Consumers Union submitted a letter to U.S. healthcare regulators, offering more than 11,000 signatures in favor of more stringent oversight of implantable medical devices.
CU urged the FDA to require that all high-risk medical implants undergo clinical testing vie the agency's premarket approval process, rather than allowing them through via the less-stringent 510(k) pathway, which requires only that a device demonstrate that it's "substantially equivalent" to a product already cleared by the FDA.
