1. Medizone inks AsepticSure evaluation deal with commercial cleaning products maker Innovasource
Medizone announced in a March 22 press release that it has signed a product evaluation agreement with Innovasource. As part of the agreement, Innovasource will be leading the evaluation of the AsepticSure system and compare it to existing cleaning practices in a number of facilities and settings. AsepticSure is designed to be used on non-porous hard surfaces that are consistent with current regulatory approval. Innovasource will also use commercially reasonable efforts to help locate third parties that want to evaluate the system.
2. Olympus launches EasySuite 4k OR system
Olympus has launched its new EasySuite 4K operating room integration system, according to a March 22 press release. The system is designed to enable surgical and interventional clinicians to connect with native and uncompressed visual insights from HD and ultra-high definition medical sources. The EasySuite 4K system is built on a 10GB IP standards-based switching backbone with enterprise-grade security features. Its features also allow physicians to see 4K video at medical-grade 60 frames per second in its original color fidelity without perceptible latency and gives a relaxing patient experience before surgery using the patient greeting system while delivering soothing images and sounds. It also allows physicians to consult virtually during cases in a rich, interactive and collaborative environment using MedPresence.
3. Balt wins FDA nod for Optima aneurysm coil, shifts U.S. HQ
Balt announced in a March 20 press release that it has received FDA 510(k) clearance for its Optima Coil System and it has completed the first of its clinical cases in the U.S. The Optima Coil System features a state-of-the-art coil, a pusher and an instantaneous thermal detachment system. Optima Coil System’s FDA clearance is the first product from Balt to be developed and cleared in the U.S. Balt also announced that it has successfully completed 60 clinical cases using the Optima Coil System and has received positive feedback from physicians during its limited market release in Europe. The Optima Coil System is one of the first products being made in Balt’s new 60,000 sq. ft headquarters in Irvine, Calif. The headquarters opened in November last year and recently completed validation of the new manufacturing facility in January.
4. Endospan wins CE Mark for Horizon EVAR
Endospan has received CE Mark approval for its Horizon Stent Graft System that is designed to treat abdominal aortic aneurysm, according to a March 21 press release. Horizon is able to be used in a 14Fr single-sided approach to shorten and simplify EVAR procedures.
5. Aziyo Biologics launches OsteGro allograft
Aziyo Biologics announced in a March 22 press release that it has launched its OsteGro allograft bone matrix that is designed to support new bone growth in orthopedic surgical procedures. OsteGro is a bone graft that acts as a scaffold for new bone growth. It can be stored at room temperature which allows it to be used in a variety of surgical procedures. Bone graft is typically used for spinal fusion, hip reconstruction and bone fractures.
6. FDA clears Respiratory Motion’s ExSpiron 1Xi minute ventilation monitor
The FDA has cleared Respiratory Motion’s ExSpiron 1Xi Minute Ventilation Monitor for pediatric patients, according to a March 22 press release. ExSpiron has been cleared for use in hospital and ancillary medical settings but has previously been used in a variety of medical environments to provide real-time, point-of-care data to help improve the care and hospital experience of adult patients who receive opioids or have an increased respiratory risk.
7. Advantis Medical Imaging wins CE Mark for Brainance MD neuroimaging cloud
Advantis Medical Imaging announced in a March 20 press release that it has received CE Mark approval for its Brainance MD cloud-based neuroimaging software. The approval allows the software to be used in clinical workflow for advanced processing of Brain MR images.