Carlsbad, Calif.-based Aurora Spine Corp. has received institutional review board approval for its multicenter study of its Zip interspinous fixation device for patients suffering from back pain due to symptomatic degenerative disc disease. The clinical trial will involve 100 patients, with results expected this year.
Batm Ltd., of Hod Hasharon, Israel, said it has developed a new molecular diagnostic test for tuberculosis (TB) using a new isothermal rolling circle amplification (RCA) process. The testing and validation phase, which is expected to begin in the second half of this year, will be funded under a program of the Stop TB Partnership, an international alliance comprising a wide range of governmental and nongovernmental organizations.
Bracco Diagnostics LLC, of Monroe Township, N.J., is partnering with Cardionavix LLC, of Wexford, Pa., to increase access to cardiac positron emission tomography (PET) imaging. The new program, the Bracco Mobile Isotope Service, will enable more patient care sites, such as community hospitals, physician practices and outpatient imaging centers, to provide cardiac PET imaging.
Coloplast A/S, of Humlebaek, Denmark, has been awarded a contract for ostomy products with Irving, Texas-based Vizient Inc. The agreement, effective July 1, 2021, allows Vizient members access with contracted pricing to Coloplast’s full portfolio of ostomy products, including ostomy pouches and supporting products. As part of the contract, Sensura Mio Baby & Kids, products developed by Coloplast for neonates, children and teenagers, will be included in Vizient’s preferred pediatric program.
Escher Biomedical Diagnostics LLC, of Houston, reported the U.S. FDA has received its emergency use authorization (EUA) application for the Escher BT-Med COV19 Saliva Test. The company said it intends to distribute the molecular test in the U.S. while FDA review of the EUA request is pending.
Calgary, Alberta-based Health Logic Interactive Inc. said its wholly owned subsidiary, My Health Logic Inc., entered an agreement with an arm’s length third party for a worldwide, exclusive license the UAL-Chip, a patent pending lab-on-chip technology with potential to be used in a smartphone-connected, hand-held device to provide rapid point-of-care (POC) diagnosis of chronic kidney disease. The UAL-Chip is being built so that results will connect to a users' phone and provide feedback in less than 5 minutes. The plan is to collect the data through My Health Logic's Matloc device, a hand-held POC device currently in development, and store the data on the My Health Logic continued care platform. The company plans to pursue an accelerated 510(k) pathway with the U.S. FDA. Financial terms of the deal were not disclosed. Health Logic also reported plans to conduct a nonbrokered private placement for gross proceeds of up to $14 million, subject to approval of the TSX Venture Exchange.
Tokyo-based Hoya Corp. confirmed that the five-year contract reported in July 2020 for technical collaboration and supply of diagnostic ultrasound systems and ultrasound sensors with Hitachi Ltd., of Tokyo, will become effective on March 31, 2021. The agreement also includes the long-term availability of spare parts to ensure best service to customers.
Westport, Conn.-based Lumendi LLC has launched Ez Glide, a hydrophilic coating applied to the inner sheath of its Dilumen endoluminal interventional platform. Ez Glide is activated by water or saline and improves endoscopic performance.
Meso Scale Diagnostics LLC, of Rockville, Md., reported the commercial release of its V-Plex serology panels for SARS-CoV-2 variants, including the B.1.1.7, B.1.351, and P1 variants.
Net Health Systems Inc., a Pittsburgh-based provider of cloud-based software for specialty medical providers, acquired Casamba LLC, an Agoura Hills, Calif.-based provider of electronic medical record solutions. Financial terms were not reported.
Royal Philips NV, of Amsterdam, and Orbita Inc., a Boston-based provider of conversational artificial intelligence (AI) solutions for health care, reported a partnership agreement to co-create next-generation conversational virtual assistants for Philips’ consumer health and patient support applications.