Ireland Issues Warning for MRI Systems
Ireland’s Health Products Regulatory Authority is warning of the potential for incorrectly installed quench lines for superconductor magnets in Siemens Healthcare’s Magnetom MRI system. In a Priority 2 warning, the HPRA says an improperly installed quench line may cause helium gas to be blown directly into the magnet room or other areas, potentially leading to the displacement of oxygen and cold burns. Siemens will inspect all sites with a Magnetom system to ensure that the quench line was installed in a manner that ensures safe operation, HPRA says.
Jan Medical Lands Funding
Mountain View, Calif.-based Jan Medical has scooped up $7.5 million in Series C funding from Brainlab for activities related to BrainPulse. Jan Medical has earmarked the funds for wrapping up clinical trials, as well as submitting a regulatory filing with the FDA and obtaining the CE Mark in the EU for BrainPulse. The device aims to detect abnormal neurological conditions — including concussion and stroke — quickly and accurately. BrainPulse works by capturing a novel, noninvasive, physiological signal that utilizes the cardiac output to measure vasculature and brain tissue conditions, according to a Jan Medical statement. Munich, Germany-based Brainlab also has committed to assist with the clinical research, regulatory filings and commercialization activities, as well as provide expertise in R&D.
Centinel Spine Scores Home Run
Ahead of the winter storm that blanketed the East Coast, New York-based Centinel Spine received FDA clearance for its Altos posterior cervical thoracic stabilization system. The system is indicated for use in either the lateral masses of the cervical spine or the pedicles of the cervical-thoracic spine. The first patient already has been implanted with the device. According to the company, Altos is the first FDA-cleared posterior cervical thoracic system intended for implantation into either the cervical lateral masses or the cervical-thoracic pedicles.
Panasonic, Kyoto University Team Up
Panasonic and Kyoto University want to make it easier to monitor the vital signs of people on the go. To that end, the two have developed a new remote sensing technology for vital signs — such as heart rate and heartbeat interval — all without placing sensors on the body. It works by combining millimeter-wave spread-spectrum radar technology and an analysis algorithm that identifies signals from the body. “Heartbeats aren’t the only signals the radar catches,” says Toru Sato, professor of communications and computer engineering at Kyoto University, in a prepared statement. “The body sends out all sorts of signals at once, including breathing and body movement. It’s a chaotic soup of information. Our algorithm differentiates all of that.” As Hiroyuki Sakai, a researcher at Panasonic, notes in the release, going sensorless allows people to monitor their health in a relaxed environment. Further, it might encourage patients to be more proactive in monitoring their own vital signs.