Houston-based Accessdx Laboratory reported its strategic partnership with Johnston, Iowa-based Jase Health. This partnership will further expedite the inclusion of Accessdx Lab's solutions, including personalized medication management, antibiotic stewardship and next-generation sequencing, directly into existing clinical workflows for thousands of health systems and provider groups.
San Diego-based Amydis Inc., an ocular tracer biotechnology company with a portfolio of diagnostic candidates for detection of neurodegenerative diseases in the eye, reported completion of pre-IND interaction with the FDA regarding the current development plan for a small-molecule retinal tracer for the diagnosis of α-synucleinopathies. Funding provided by The Michael J. Fox Foundation for Parkinson’s Research supported the preclinical data for the pre-IND submission. In addition, the pre-IND dossier included information on manufacturing and the design of the proposed phase I/IIa clinical study.
Franklin Lakes, N.J.-based Becton, Dickinson and Co. (BD) said it has submitted a 510(k) premarket notification to the FDA for its BD Alaris system. The submission is intended to bring the regulatory clearance of Alaris up to date, implement updated features and address open recall issues, including a new version of the BD Alaris system software that will provide clinical, operational and cybersecurity updates.
San Carlos, Calif.-based Biocardia Inc. said it has entered an agreement with an unnamed Japanese biotechnology company related to Biocardia Helix catheter biotherapeutic delivery product candidates. Under the terms of the agreement, Biocardia will receive $500,000, a portion of which is creditable for biotherapeutic delivery products and support services. The agreement has a one-year term with an option to negotiate for a nonexclusive worldwide license to Biocardia Helix catheter biotherapeutic delivery product candidates for certain cell types for cardiac indications.
Dallas-based Djo Global LLC, a subsidiary of Colfax Corp., has completed its acquisition of Medshape Inc., an orthopedic medical device company based in Atlanta. Terms of the transaction were not disclosed.
Ekso Bionics Holdings Inc., of Richmond, Calif., is partnering with Royal Rehab, a Sydney-based provider of rehabilitation and disability support services, to advance exoskeleton technology in Australia.
Eurofins subsidiary Empower Dx Inc., of Framingham, Mass., is working with San Francisco-based Uber Technologies Inc. to offer Empower Dx’s FDA emergency use authorized SARS-CoV-2 RT-PCR assay kits via on-demand delivery in more than two dozen U.S. cities.
Melbourne, Australia-based Genetic Technologies Ltd. said its COVID-19 Serious Disease Risk Test is now approved for commercial release in the U.S. The company submitted the test to FDA via Infinity Biologix LLC, of Piscataway, N.J. The release is expected to occur no later than the end of May, once the technical interface for the U.S. telehealth platform is completed by Infinity Biologix’s telehealth partners.
Heartflow Inc., of Redwood City, Calif., said the U.K.’s National Institute for Health and Care Excellence has renewed its support for the use of its artificial intelligence-powered Heartflow FFRct Analysis to fight coronary heart disease (CHD). According to the company, NICE found that the Heartflow Analysis continues to improve patient experience and reduce the need for invasive angiography, four years after its initial recommendation that the technology be used to support CHD diagnosis within the National Health Service. NICE further estimated that using the Heartflow Analysis represents a cost saving of £391 (US$543) per patient to NHS England, £177 higher than original calculations suggested in 2017.
Norcross, Ga.-based Immucor Inc. said the Palmetto Moldx has finalized a local coverage determination for molecular testing for solid organ allograft rejection. The policy change, which takes effect June 6, 2021, will enable patients to benefit from Immucor’s Ksort noninvasive gene expression assay, which is designed to monitor and support the health of solid organ transplant recipients.
Minneapolis-based Inspire Medical Systems Inc. reported an exclusive distribution agreement with Japan Lifeline Co. Ltd., of Shinagawa-ku, Japan, to commercialize Inspire technology in Japan. The agreement follows successful completion of reimbursement review of Inspire therapy by the Minister of Health, Labour and Welfare. Formal listing of Inspire therapy in the Japan National Health Insurance Listing is expected to occur in June 2021.
Budapest-based Mediso Medical Imaging Systems completed the technology transfer of the Cameleon4 MRI spectrometer developed by Rs2d, of Strasbourg, France. The new console will be integrated into Mediso’s Nanoscan cryogen-free 3T and 7T MRI product line to improve imaging performance.
Dublin-based Medtronic plc and Surgical Theater LLC, of Los Angeles, reported a collaboration to enable neurosurgeons to use Surgical Theater’s Syncar augmented reality technology with Medtronic’s Stealthstation S8 surgical navigation system to enhance visualization during complex cranial procedures.
Microbix Biosystems Inc., of Misissauga, Ontario, and Speedx Pty. Ltd., of Sydney, formed a collaboration under which Microbix will be the exclusive developer of quality assessment products to facilitate the registration and commercialization of Speedx diagnostic assays.
New York-based Tytocare Ltd. launched its all-in-one remoted medical exam platform in Italy via partnership with Multimed Srl, of Turin, Italy.
Vitalhub Corp., of Toronto, reported that the Montreal-based regional health network CIUSS du Nord-l’île-de-Montréal licensed the Shrewd Resilience and Action modules from Vitalhub’s recently acquired subsidiary, Transforming Systems Ltd., of Cirencester, U.K.