Siemens Medical Solutions Inc. received FDA 510(k) premarket clearance for its Magnetom Terra seven tesla (7T) MRI system, the first to be available for clinical use in the U.S. The device is powered with more than twice the magnetic field strength of the current strongest MRI in a 3T system, enhancing the ability to image structures.
Respicardia Inc. received FDA approval for its Remedē system for central sleep apnea (CSA), widening treatment options for the condition often tied to negative cardiovascular impact. The implantable device stimulates the phrenic nerve automatically to impact the diaphragm while a patient sleeps.