Acutus Medical Inc., of Carlsbad, Calif., and Berlin-based Biotronik reported a new alliance to provide a comprehensive portfolio of electrophysiology, mapping, ablation and accessory products for catheter-based treatment of cardiac arrhythmias across select markets, including Europe and Asia. The Biotronik/Acutus Alliance for Electrophysiology focuses on the Acutus Acqmap system with Supermap multimode mapping capabilities.
Ar Tech, a division of Fontana, Calif.-based A&R Tarpaulins Inc., an aerospace and medical equipment manufacturer, received emergency approval for the use of its patient isolation transportation unit (PITU) from the U.S. FDA. PITU is designed to temporarily isolate and transport patients with confirmed or suspected COVID-19 infection.
Avacta Group plc, of Wetherby, U.K., entered an exclusive distribution agreement with Manchester, U.K.-based Medusa19 Ltd. for direct-to-consumer sales of a saliva-based rapid test for the COVID-19 antigen. Medusa19’s initial focus will be on COVID-19 home testing, and it is currently investing in global e-commerce, logistics and customer support infrastructure in preparation for Avacta’s COVID-19 test launch. Medusa19 also will have nonexclusive rights to supply the tests to businesses for workforce testing. The distribution agreement includes a profit-sharing arrangement.
Austin-based Babson Diagnostics Inc. is collaborating with Dell Medical School at the University of Texas at Austin to study the immune response to COVID-19. The longitudinal research study is designed to measure the adaptive immune response to SARS-CoV-2 by following individuals over a two-year period. The initial phase of the study includes 200 COVID-19-positive individuals. The news follows the recent launch of Babson’s IgG serology test, which yielded 93.2% sensitivity and 100% specificity in its clinical performance evaluation and has been submitted to the U.S. FDA for emergency use authorization.
Biodesix Inc., of Boulder, Colo., is partnering with Boulder Community Health (BCH), a community owned-and-operated not-for-profit health system, to offer expanded COVID-19 testing in the region. The Biodesix SARS-CoV-2 ddPCR Test detects COVID-19 with greater sensitivity than other available tests, according to the company, and is now accessible by appointment at drive-up locations in Boulder and Erie.
Biolab Sciences Inc., a Scottsdale, Ariz.-based regenerative biotechnology company, reported a partnership with Red One Medical, of Savannah, Ga., that will help veterans and active military members access wound healing and regenerative medicine.
Color, of Burlingame, Calif., received an emergency use authorization from the U.S. FDA to use loop-mediated isothermal amplification (LAMP) technology for COVID-19 testing. Color is publishing its protocol for LAMP for other labs to replicate. Color also has posted a protocol for employers to offer accessible testing in the workplace.
Eagle Genomics, of Cambridge, U.K., said that Cargill Inc., of Minneapolis, has signed a multi-year platform agreement to enable the digital transformation of microbiome and life sciences R&D across its global locations. The deployment of the Eagle Genomics e[datascientist] platform intially will enable Cargill's health technologies business to organize and synthesize additional insights from microbiome data amassed by the company over the past decade.
Cambridge, Mass.-based Egenesis, a biotechnology company using gene-editing technologies for the development of human-compatible organs, tissues and cells, reported the acquisition of the assets and operations of Mount Horeb, Wisc.-based Icbiotec (ICB), one of its key production partners. Under the terms of the transaction, Egenesis will acquire ICB’s existing facilities, equipment, and land. ICB’s research and operations staff will continue as employees of a wholly owned subsidiary of Egenesis. The acquisition will provide Egenesis with full control of an xeno-organ supply chain. Financial terms were not disclosed.
Eko Devices Inc., of Oakland, Calif., unveiled Eko Telehealth, what the company has called the first artificial intelligence-powered telehealth platform for virtual cardiac and pulmonary monitoring.
Enzo Biochem Inc., of New York, said that it is offering a SARS-CoV-2 IgG ELISA assay kit for serological detection of IgG antibodies against the novel coronavirus under the U.S. FDA’s emergency use authorization authority as both products and services.
G Medical Innovations Holdings Ltd., of Rehovot, Israel, was granted emergency use authorization by the U.S. FDA for its Vital Signs Monitoring System ECG Patch for the remote monitoring of the QT interval of an electrocardiogram in hospitalized COVID-19 patients being treated with drugs that can prolong the QT interval, causing potentially fatal arrhythmias.
Melbourne, Australia-based Genetic Technologies Ltd. said it is accelerating development of a polygenic risk score test to predict an individual’s risk of developing life-threatening complications should they contract COVID-19.
Beijing-based precision medicine company Genetron Holdings Ltd., has teamed up with Guangzhou Darui Biotechnology Co. Ltd., of Guangzhou, China, to develop pathogenic microorganism detection products and apply for registration of reagent kits using the Genetron S5 next-generation sequencing platform.
Keter North America Inc., of Boca Raton, Fla., has adapted its operations to produce high-quality, reusable face shields at its plants in Anderson, Ind., and Milton, Ontario. Both facilities have the capacity to make about 50,000 face shields a week.
Konica Minolta Medicine Inc., of Aliso Viejo, Calif., has acquired the assets of Boston-based Backpack Health LLC, a secure mobile and web-based health data management platform. Financial terms of the deal were not disclosed.
Seoul-based Macrogen Inc. received a green light from South Korea’s Ministry of Food and Drug Safety to export its Xen COVID-19 RT-PCR test. The company is currently preparing to obtain U.S. FDA emergency use authorization and CE-IVD marking in Europe for the test.
Seattle-based Nanostring Technologies Inc. and Onramp Bioinformatics Inc., of San Diego, are partnering to develop new analysis tools for data generated on Nanostring’s Ncounter analysis system. The new analysis functionality is built into Rosalind, Onramp’s cloud-based analysis suite. The companies are releasing the new capabilities through early access and offering them immediately to COVID-19 researchers conducting critical host response studies on the Ncounter platform.
Parexel Inc., of Waltham, Mass., has launched #Keepingpatientsfirst, an integrated real-world evidence research platform powered by Microsoft Azure providing rapid access to new COVID-19 data.
Irvine, Calif.-based Pathnostics has launched a COVID-19 PCR laboratory test designed to detect acute infection. The company said it will perform its test based on Waltham, Mass.-based Thermo-Fisher Scientific Inc.’s Taqpath RT-PCR COVID-19 kit, which received emergency use authorization from the U.S. FDA in March.
Austin-based Phunware Inc. is collaborating with Hewlett Packard Enterprises, of Palo Alto, Calif., to offer HP’s customers a “digital front door” software on mobile by integrating HP’s Aruba Networks mobility tools with Phunware’s multiscreen-as-a-service health care products and solutions.
Quantlase Imaging Lab, the medical research arm of Abu Dhabi-based International Holdings Co., said it has developed novel equipment that enables much faster mass screenings, with test results available in seconds. The laser-based diffractive phase interferometry technique uses a complementary metal oxide semiconductor (CMOS) detector, is reportedly user-friendly, noninvasive and low-cost.
Spineway SA, of Ecully, France, said it has secured a government-backed loan of €1.13 million ($US1.24 million) as a result of the COVID-19 pandemic, allowing it to maintain activities until spinal surgeries resume in areas where it operates.
Trugenomix Health Inc., of Rockville, Md., is partnering with global bioinformatics platform Bluebee, of Rijswijk, Netherlands, to create a next-generation behavioral science data ecosystem for the early detection of people at risk of developing post-traumatic stress disorder due to the COVID-19 pandemic.
Shanghai-based companies Vechain and I-Dante Ltd. reported the joint development of E-Hcert, a blockchain-based COVID-19 records app for the citizens of Cyprus.
Toronto-based Vexos Inc. has signed an exclusive license agreement with Elemaster Group, or Lomagna, Italy, to manufacture and distribute the MVM (Mechanical Ventilator Milano) Ventilator for the Americas. The MVM Ventilator was approved by the FDA for emergency use authorization during the coronavirus pandemic on May 1.