Advanced Sterilization Products Inc., of Irvine, Calif., reported it has qualified a new reprocessing protocol that can triple the lifespan of single-use N95 masks using the Sterrad systems already available in most hospitals. According to the company, health care facilities can reprocess up to 480 masks per Sterrad sterilizer machine, daily.
Edwards Lifesciences Corp., of Irvine, Calif., reported it will temporarily pause new enrollments in its active pivotal clinical trials of transcatheter mitral and tricuspid therapies as a result of the COVID-19 pandemic. The company said it is coordinating closely with the trials’ clinical investigators, and the decision to resume enrollments in the trials will be made in consultation with each investigator and hospital at the time when their clinicians’ and patients’ needs can be better served.
Fluxergy LLC, of Irvine Calif., said it submitted an emergency use authorization request to the U.S. FDA that would permit medical professionals to begin using the company's high-speed research use only test system as a COVID-19 diagnostic at the point-of-care. The Fluxergy Analyzer system, which utilizes PCR and microfluidics technology, has been shown to accurately identify the SARS-CoV-2 virus in under one hour in bench lab tests performed by the company and in follow-up validation tests completed by researchers at University of California San Diego.
KC Wearable, of Shenzhen, China, has launched a symptom detector to quickly screen fevers in public places in the fight against COVID-19. The KC Wearable Smart Helmet enables the user to monitor up to 13 individuals’ temperature at once, with up to 200 people being screened per minute.
Maker Mask, a nonprofit initiative led by Rprime co-founder Jonathan Roberts, is offering a medically approved design for 3D printing of protective masks free of charge to the government and health care organizations in response to the COVID-19 pandemic. Maker Mask has launched a crowd-sourcing pilot in Seattle with 20 3D printers and expects to be making 1,000 masks by April 3, operating around the clock. The group expects to soon have hundreds of small batch production sites operating across the U.S.
New York-based Medsign International Corp. reported the launch of Qortex, a home TV-based telehealth solution that allows clinicians to deliver virtual medical services to patients confined to their homes, particularly during the COVID-19 crisis. Comprised of a communication hub, high-definition camera and senior-friendly remote control, the Qortex system connects with any internet service and HDMI television and is compatible with all smartphones and tablets.
Medtronic plc, of Dublin, said that is publicly sharing the design specifications for the Puritan Bennett 560 ventilator to speed efforts to increase global ventilator production during the COVID-19 pandemic.
Nano Retina Ltd., of Herzliya, Israel, reported preliminary results for the first two first-in-human implantations of its NR600 artificial retina device. The implantations were part of a European multicenter study of up to 20 patients aimed at supporting CE mark approval for the NR600. Both patients reported visual effects, the company said, adding it expects those effects to optimize over the coming months.
Miami-based Neocis Inc. said it has filed for FDA clearance of its Yomi edentulous splint. The device will enable the Yomi Dental Robotic system to beyond placing implants on patients who have lost some of their teeth to assisting doctors with full arch implant cases.
Airport City, Israel-based startup Novasight Ltd. has launched two telehealth solutions focused on children’s vision. The FDA-registered and CE-marked Eyeswift vision assessment system offers 11 different vision exams, including visual acuity and eye misalignment. Novasight’s Curesight is an eye-tracking system for lazy eye treatment.
Opgen Inc., of Gaithersburg, Md., said its shareholders have approved a proposed merger with Curetis NV, of Holzgerlingen, Germany. The deal, terms of which were not disclosed, is expected to close in the coming days.
Parallax Health Sciences Inc., of Santa Monica, Calif., reported that its wholly owned subsidiary, Parallax Diagnostics Inc., has entered a joint venture with Tampa, Fla.-based Sagico USA to facilitate the procurement of personal protection equipment and COVID-19 tests kits from FDA-registered suppliers. Available items are included on the Parallax online portal and are also available for export to other countries.
Houston-based Precheck Health Services Inc. has entered an exclusive agreement with Co-Diagnostics Inc., of Salt Lake City, to distribute COVID-19 PCR tests in Afghanistan, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan and Uzbekistan. The agreement follows similar agreements with Co-Diagnostics for Russia, Ecuador, Panama, Romania and Moldova.
Renovacare Inc., of Roseland, N.J., reported that its Skingun is being used to apply regenerative cells in a preclinical study of new gene therapies. Researchers at King’s College London, U.K., are using the Skingun to spray gene-supplemented cells for accelerated wound healing in recessive dystrophic epidermolysis bullosa, a debilitating that affects young children and leads to premature death.
London-based Smiths Group plc confirmed that has contracted to produce 10,000 of its Parapac Plus ventilators for the U.K. government. The company said it is also in discussions with potential partners around the world to make its ventilator, in support of the fight against COVID-19.
Singapore-based Vela Diagnostics Pte. Ltd. said it expects to get FDA emergency use authorization for its manual Virokey SARS-CoV-2-RT-PCR test by early April and will begin offering it for COVID-19 testing. The test is on track to receive CE-IVD approval by the end of March.