Braincool AB, a Lund, Sweden-based medical device innovator, has completed patient recruitment in the Scandinavian multicenter pivotal trial of 180 patients to investigate the Cooral System for prevention of oral mucositis.
CHF Solutions Inc., of Eden Prairie, Minn., reported the initiation of distribution agreements covering Germany, Austria and Switzerland with Neucomed Group and its affiliates. The company now has distribution partnerships covering 13 countries worldwide.
Ergotron, of Saint Paul, Minn., partnered with Ingram Micro China to donate medical carts to two hospitals in Wuhan, China, the city at the epicenter of the recent COVID-19 outbreak. The carts were provided to Huoshenshan and Leishenshan hospitals.
Rochester Hills, Mich.-based Infusystem Holdings Inc. entered an agreement through which it will add negative pressure wound therapy to its integrated therapy service platform.
Laborie Medical Technologies, which has a presence in Williston, Vt., and Mississauga, Ontario, has completed its acquisition of Salt Lake City-based Clinical Innovations LLC for an enterprise value of $525 million. Clinical Innovations is a provider of clinician-preferred medical devices for the labor & delivery and neonatal intensive care unit specialties.
Irvine, Calif.-based MRI Interventions Inc. officially changed its corporate name to Clearpoint Neuro Inc. Feb. 12. Its common stock will commence trading under the symbol CLPT.
Myriad Genetics Inc., of Salt Lake City, submitted a supplementary premarket approval application to the U.S. FDA for its Mychoice Cdx test to help identify women with advanced ovarian cancer who are potential candidates for maintenance therapy with Lynparza (olaparib) in combination with bevacizumab. Myriad’s filing is based on the positive results from the phase III PAOLA-1 trial of Lynparza that was published online in the New England Journal of Medicine in December 2019.
Neovasc Inc., of Richmond, British Columbia, reported the achievement of design freeze for its fully retrievable transfemoral trans-septal Tiara system, including a modified, lower profile valve and a steerable delivery system.
UW Health’s University Hospital in Madison, Wis., became the first health care facility in the U.S. to install the Artis icono biplane system from Siemens Healthineers, which has a presence in Malvern, Pa.
Vela Diagnostics, of Singapore, has developed the Virokey SA201 COVID-19 RT-PCR Test, a new diagnostic test for the detection of the COVID-19 coronavirus. The company is in discussions with the U.S. FDA for clearance of the test under the emergency use authorization. The ViroKey SA201 COVID-19 RT-PCR Test will be officially available by the end of February with the facility to preorder now.
Vitalconnect Inc., of San Jose, Calif., reported the introduction of arrhythmia detection to its remote monitoring portfolio. In partnership with Corvitals Inc., which has a presence in North Babylon, N.Y., Houston and Doncaster, U.K., Vitalconnect now offers physicians the ability to monitor, diagnose and treat patients suffering from various heart conditions and diseases.
With the end of the extended Lunar New Year holiday, Wuxi Apptec, of Shanghai, said sites in China have resumed operations, with the exception of the one in Wuhan.
Xrhealth, of Brookline, Mass., reported the first virtual reality (VR) telehealth clinic that will provide VR therapy to patients.