Esteem totally implantable hearing device under consideration for approval in U.S.: The Food & Drug Administration’s Ear, Nose, and Throat Advisory Committee is considering whether to recommend approval of Envoy Medical’s fully implantable hearing aid. The Esteem device uses a piezoelectric sensor to monitor the eardrum and convert the signal into digital for processing. The processed information is then converted back into physical vibrations and applied to the stapes capitulum. MedPage Today reports that a recent clinical trial showed that the device improved the hearing of a good number of subjects, but almost half experienced some sort of adverse effects such as taste disturbance and facial palsy.
Bayer’s new blood glucose meter with USB connectivity: Bayer released the Contour USB blood glucose meter that plugs directly into a Windows or Mac computer to upload readings for later analysis and sharing with doctors. The device shows readings on the screen and lets patients denote whether they were taken before or after a meal. Conveniently, there’s also about 500 megabytes of empty storage space on the unit, so it can be used as a traditional USB thumb drive as well.
eXimia NBS system for non-invasive brain mapping gets U.S. OK: The Food & Drug Administration approved Nexstim’s navigated brain stimulation system for the “assessment of the primary motor cortex for pre-procedural planning.” The system uses traditional MRI data to guide the transcranial brain stimulation (TMS) device to map the motor cortex so as to avoid performing direct cortical stimulation during brain surgery.
Cardiopulmonary bypass pump brings attractive aesthetics to grim situations: In October, Lifebridge Medizintechnik of Ampfing, Germany, won Food & Drug Administration approval for the B2T heart-lung machine. The portable unit is designed to be percutaneously connected to the patient for quick circulatory support during acute cardiac failure. Last year this system won a red dot product design award.
A weekly roundup of new developments in medical technology, by MedGadget.com.