Acutus Medical Inc., of Carlsbad, Calif., reported preclinical results of a novel diagnostic and therapeutic workflow utilizing its Acqmap system along with tissue-selective, nonthermal pulse field ablation (PFA) via an Acutus ablation catheter. The workflow involved ultrasound imaging of whole-chamber cardiac anatomy and noncontact mapping of electrical activity, followed by the delivery of four to eight contiguous ablation lesions via the PFA catheter. Noncontact mapping was then used to assess and confirm the effectiveness of therapy in the treated regions. In multiple tests, the whole chamber map/ablate/remap to confirm block workflow was completed in an average of 12 minutes. Acute ablation was further confirmed by conventional high-density contact mapping of the treated region with the Acqmap system and a contact mapping catheter. Ten-day follow-up confirmed the durability of lesions in the treated model.
Denver-based Assure Holdings Corp. reported that it defaulted on its loan from Central Bank & Trust, a part of Farmers & Stockmens Bank. Central Bank has not made a demand for repayment of the proceeds advanced under the Aug. 12, 2020, loan agreement. Assure and the bank are working to revise certain terms of the loan agreement. In addition, the company said that Scott Page has resigned from the board of directors.
Avacta Group plc, of Wetherby, U.K., will launch an ELISA laboratory test for the SARS-CoV-2 spike protein to support global research efforts into the coronavirus that causes COVID-19. The company plans to supply the reagent kit directly and is also in discussions with potential OEM partners and distributors globally.
Salt Lake City-based Co-Diagnostics Inc. has entered an agreement with Arches Research Inc., a subsidiary of Polarity TE Inc. with headquarters in Salt Lake City, to expand Arches’ COVID-19 testing services using Co-Diagnostics’ Logix Smart COVID-19 test kit.
San Diego-based Confirm Biosciences Inc. has earned an ISO 13485:2016 certification from UL for its quality management system to handle medical devices and related services.
Cytosorbents Corp., of Monmouth Junction, N.J., said the U.S.-based Cytosorb Therapy in COVID-19 ICU Patients (CTC) Registry is now live and actively enrolling patients. The registry is designed to capture anonymized clinical outcomes data on adult, critically ill, COVID-19 patients treated with Cytosorb. The blood purification technology received U.S. FDA emergency use authorization in April.
Brossard, Quebec-based Diagnos Inc. has received $2 million in assistance from the government of Quebec to accelerate commercialization of CARA, an artificial intelligence-powered tool for computer-assisted retinal analysis.
Diasorin sPa, of Saluggia, Italy, and Memed Ltd., of Haifa, Israel, are teaming up to speed the development and commercialization of a novel, host-protein signature-based assay. Under the terms of the agreement, Diasorin has acquired the rights to commercialize the Memed Bv test on its Liaison family of analyzers. The companies expect to make the Memed Bv test available on over 5,000 Liaison Xl and Liaison Xs platforms installed worldwide.
South San Francisco-based Fluidigm Corp. said has achieved the initial milestone under its letter contract with the National Institute of Biomedical Imaging and Bioengineering, under NIH’s Rapid Acceleration Diagnostics initiative. The letter contract, which established $12 million of available funding to Fluidigm prior to a definitive contact, provided for payment of roughly $11 million when the company completed an independent third-party verification of its Advanta Dx SARS-CoV-2 RT-PCR assay, which won U.S. FDA emergency use authorization late last month. Fluidigm expects to receive the full $12 million by the end of the 2020 third quarter and is working with NIH to finalize the definitive contract.
Freudenberg Medical LLC, of Beverly, Mass., has acquired the hypotube manufacturing business of South Jordan, Utah-based Merit Medical Inc. The acquired assets will be absorbed by Cambus Medical Ltd., a Freudenberg company located in Galway, Ireland, that is focused on hypotube manufacturing.
Grifols SA, of Barcelona, Spain, said it has entered a transaction to acquire the remaining equity of Alkahest Inc., a San Carlos, Calif.-based developer of plasma therapies, in exchange for a total price of $146 million, on a debt-free basis. No additional financing will be required. The closing of the transaction is subject to the approval by the relevant antitrust authorities and is expected to close in early 2021.
Hoffmann-La Roche Ltd. (Roche Canada), of Mississauga, Ontario, and Laval, Quebec, reported that Foundationone Liquid CDx, Foundation Medicine's comprehensive pan-tumor liquid biopsy test for patients with solid tumors, is now available in Canada. Roche Canada has an exclusive license to market these services in Canada.
Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., reported that Thermo Fisher Scientific Inc., of Waltham, Mass., has signed a letter of intent to manufacture Inovio’s DNA COVID-19 vaccine candidate INO-4800.
Irhythm Technologies Inc., a San Francisco-based digital health care solutions company focused on the advancement of cardiac care, was named a winner of the Artificial Intelligence (AI) in Health and Care Award, granted by the Accelerated Access Collaborate as part of the NHS AI Lab. Irhythm will use the funding to trial its Zio service in selected sites in the U.K.
Laboratory Corp. of America Holdings (Labcorp), of Burlington, N.C., launched a single panel test to simultaneously detect COVID-19, influenza A/B, and respiratory syncytial virus. Labcorp has submitted an application to the U.S. FDA to offer the combined test through its Pixel by Labcorp at-home test collection kit.
Neuronostics Ltd., of Exeter, U.K., has received funding to develop its Bioep platform, an artificial intelligence (AI)-based system for faster, more accurate diagnosis of epilepsy and to monitor response to treatment with anti-epileptic drugs. The funding, received as part of an AI in Health and Care Award from the National Institute for Health Research, will enable the research partnership to progress a prototype clinical platform that can provide a risk score showing the individual’s susceptibility to seizures.
Qiagen NV, of Hilden, Germany, said it plans to launch a rapid portable test that can detect SARS-CoV-2 antigens in people with active infections in less than 15 minutes and process on average around 30 swab samples per hour using a small digital detection system. Two versions of the Access Anti-SARS-CoV-2 Antigen Test are scheduled for U.S. launch in the fourth quarter – one for labs and one for point-of-care use.
Seegene Inc., of Seoul, South Korea, reported it launched a single tube real-time RT-PCR assay, the Allplex SARS-CoV-2/FluA/FluB/RSV Assay, which simultaneously detects and differentiates influenza A/B, respiratory syncytial virus A/B, and three different target genes of COVID-19 (S gene, RdRP gene and N gene).