From Medizone’s evaluation deal to Advantis Medical Imaging getting CE Mark approval, here are medtech stories we missed this week but thought were still worth mentioning.
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.