Advanced Ultrasound Systems, of Tulsa, Okla., said it has partnered with Vancouver, Wash.-based Nautilus Inc. to expand telehealth and remote medical imaging capabilities through Nautilus Teleray systems.
Ams AG, of Premstätten, Austria, and Precision Biomonitoring Inc., of Guelph, Ontario, have forged a global partnership to enable pandemic control through the development of a rapid saliva antigen testing device for COVID-19. The easy-to-use, lab-free SARS-CoV-2 antigen test aims to provide reliable results in about 15 minutes at the point of care.
Brea, Calif.-based Beckman Coulter Inc. has launched its Access SARS-CoV-2 Antigen assay in the U.S. at a cost of $4 to providers, making it affordable for mass testing. The assay runs on Beckman Coulter analyzers capable of processing up to 200 samples per hour, enabling throughput screening in just 30 minutes. The company is submitting for emergency use authorization from the U.S. FDA and can ship up to 25 million tests per month.
Biospyder Technologies Inc., of San Diego, reported that its Glasgow, U.K.-based spinout, Bioclavis Ltd., has launched a barcode-style COVID-19 test aimed at organizations that wish to test members cost-effectively. The Biospyder Tempo-Span assay does not require RNA extraction, and each individual patient sample is molecularly barcoded to enable precise identification of results within a group of samples analyzed, enabling up to 96 samples in a single well.
Los Angeles-based Decision Diagnostics Corp. said it is proceeding with final testing of its Genviro! COVID-19 Saliva Swift Kit and will continue efforts to bring the technology to the market. Initially, the company will release a series of test results collected from its Korean partner, from the detailed XPRIZE sample testing, and as it becomes available, from its U.S.-based testing, all of which will be submitted to the U.S. FDA for emergency use authorization consideration.
Edwards Lifesciences LLC, of Irvine, Calif., reported the first patient was treated in its RESTORE clinical trial, which will assess the safety and effectiveness of the Harpoon Beating Heart mitral valve repair system in the U.S. and Canada. The procedure took place at the University of Maryland Medical Center in Baltimore.
Ann Arbor, Mich.-based Endra Life Sciences Inc. said it has renewed its collaboration agreement with GE Healthcare Inc., of Chicago, extending the term by two years to Dec. 16, 2023. The agreement supports commercialization of Endra’s Taeus product for imaging for nonalcoholic fatty liver disease and nonalcoholic steatohepatitis.
Guided Therapeutics Inc., of Peachtree Corners, Ga., reported the opening of the Luviva Reference and Training Center in Budapest, Hungary, to support sales and training in Europe. The center, established at Budapest Medical Bella Women’s Health Clinic, is cosponsored by the company and its European manufacturing and distribution partner, Newmars Technologies Kft., of Budapest.
Austin, Texas-based Harmonic Bionics Inc. reported they will be partnering with Korean-based H Robotics Inc. to assist with the U.S. distribution of Rebless, a smart rehabilitation device. Rebless is an FDA-registered robotic, exercise therapy device for both upper and lower limbs, providing motion to the elbow, wrist, ankle, and knee joints. Rebless is controlled through an app downloaded onto the patient's smart phone or mobile device. Care providers will use the Rebless Clinic software to prescribe exercise regimens, manage and export patient output, and perform telemedicine visits.
Saint Petersburg, Fla.-based Motility Medical Inc., a biotech startup that is developing a neuromodulation device to treat patients who suffer from chronic constipation, has started human trials for their prototype device. The Motility Medical device interfaces with nerves and muscles to facilitate bowel activity without the use of oral pharmaceuticals. Amol Soin, CMO and co-founder of Motility is the principal investigator of the current device optimization trial in Dayton, Ohio.
Shenyang, China-based Neusoft Medical Systems Co. Ltd. reported the cloud signing of a memorandum of understanding (MOU) with Karachi, Pakistan-based Dynamic Engineering and Automation Group (DEA) to cooperate in the area of health care in Pakistan. The partnership intends to promote advanced imaging modalities technology combined with cloud imaging solution, AI technology, health management, academic communication, and training and education program, together with the nationwide service network project, through leveraging the strengths of both companies.
Paris-based Novacyt SA reported that following the detection of a new variant of COVID-19 by the U.K.’s COVID-19 Genomics UK consortium, known as VUI-202012/01, the company has carried out a detailed analysis of the mutations in this new variant and in all published COVID-19 strains to fully assess the reliability of its existing diagnostic tests. The results of the in silico (computer simulation) analysis of the sequenced mutations show that its polymerase chain reaction product portfolio, based around a single and a two gene target for COVID-19, remain able to detect all published COVID-19 strains with the same level of accuracy, including VUI-202012/01.
Tokyo-based Olympus Corp. reported the first patient enrolled in an international study to collect real-world evidence on the performance of the new Soltive premium superpulsed laser system for breaking up kidney and ureteral stones. Wilson Molina, professor of urology at the University of Kansas School of Medicine, performed the first case. The primary goal of the study is to measure the number of patients who remain free of stones after three months following treatment. The current stone-free rate using older technology like Holmium YAG is between 65% and 92%, with the rate dependent upon the number of stones and the stone size, location, and composition. Up to 450 patients will be enrolled in the post-market registry study that will be conducted at up to five centers in the U.S., three centers in Europe, and one center in Canada.
Suzhou, China-based Peijia Medical Ltd. and Highlife SAS, a Paris-based company focused on the development of a unique transeptal mitral valve replacement (TMVR) system to treat patients suffering from mitral regurgitation, reported that they have entered into a license agreement pursuant to which Highlife has granted to Peijia an exclusive license regarding certain TMVR products currently in development by the licensor. Peijia is entitled to, among other things, manufacture, develop, and commercialize the products in the greater China region, and Highlife is in return entitled to receive an upfront fee and subsequent milestone payments. Under the agreement, Peijia and Highlife will establish a joint review committee to enhance a mutual sharing of information about the development as well as commercialization of the TMVR products. The terms also allow cross-licensing on future improvements of the products, encouraging both companies to focus on innovations.
Toronto-based Profound Medical Corp. has entered into a co-development agreement with Chicago-based GE Healthcare. The companies have agreed to a non-exclusive, worldwide license that will enable Profound to interface its Tulsa-Pro system with certain GE Healthcare MRI scanners. The collaboration with GE Healthcare expands Profound’s potential to interface with a significant portion of GE’s new and currently installed MRI scanners globally.
Q2 Solutions, the Morrisville, N.C.-based joint venture of Iqvia Inc. and Quest Diagnostics Inc., reported a partnership with Adaptive Biotechnologies Corp., of Seattle. Q2 Solutions will offer its customers the ImmunoSEQ assay, Adaptive’s immunosequencing solution. Q2 Solutions will also offer Immunoseq T-Map COVID, a research product and data analysis service to assess the T cell immune response to COVID-19 vaccines in development. The specific terms of the partnership are confidential.
Sifi SpA, of Catania, Italy, said it launched the Well Fusion system and the Mini Well Proxa intraocular lens for presbyopia. The lens is now commercially available in Italy, Romania and Spain; other European countries will follow in 2021.
Sun Genomics Inc., of San Diego, reported the launch of its at-home Floré Labs COVID-19 Stool Test to identify whether an individual has viral shedding of SARS-CoV-2.
Valgen Medtech Co. Ltd., of Binjiang, China, reported the first clinical application of the Dragonfly-T transcatheter tricuspid valve clamping system in that country. The patient was a 70-year-old woman with recurrent chest tightness and a diagnosis of atrial fibrillation, functional tricuspid regurgitation, class IV cardiac function and ascites. The procedure, performed at the Second Hospital of Zhejiang University School of Medicine, involved general anesthesia with a femoral vein approach.
Votis Subdermal Imaging Technologies Ltd., of Jerusalem, and Ii Ventures Pvt. Ltd., of Mumbai, India, entered a memorandum of understanding to develop a system to screen the largely rural Indian population for peripheral artery disease. The system will utilize the same technology that Votis is building into other devices intended for use in the U.S. and Europe.