Montréal-based Alithya Group Inc., a supplier to the nuclear industry, has partnered with the Canadian Nuclear Isotope Council (CNIC) to support the Canadian isotope sector with its artificial intelligence, automation and digital systems expertise. The goal is to accelerate progress in medical isotope innovation and automation.
Stony Brook, N.Y.-based Applied DNA Sciences Inc. said that its Linea COVID-19 Assay Kit identified COVID-19-positive samples that are variants distinct from the wild-type virus that has dominated the U.S. in the pandemic until now. The variants were identified as part of the company’s Safecircle pooled surveillance testing service, which is powered by the company’s assay kits.
Vancouver, British Columbia-based Artms Inc. and Isotopia Molecular Imaging, of Petach Tikva, Israel, reported the successful radiolabeling of Isotopia’s prostate cancer imaging kit product, PSMA-11, with more than 2 Ci of cyclotron-produced Gallium-68 using Artms’ proprietary Quantum Irradiation System solid target system.
Minneapolis-based Cardialen Inc. won a $2.8 million NIH phase II SBIR grant to further the clinical study of its low-energy cardioversion of atrial fibrillation in human subjects in the U.S.
San Diego-based Cue Health Inc. said that its molecular, point-of-care COVID-19 tests are being distributed to five additional states: Colorado, Minnesota, Pennsylvania, Rhode Island and Utah, as part of the joint $481 million program with the U.S. Departments of Health and Human Services and Defense.
Parsippany, N.J.-based Diaceutics plc reported a strategic partnership with Canadian Pathology Quality Assurance to advance the development of Neurotrophic Tropomyosin Receptor Kinase Ihc proficiency testing globally.
Basking Ridge, N.J.-based Electrocore Inc. said that U.S. Centers for Medicare and Medicaid Services published its most recent level II Healthcare Common Procedure Coding System decisions on Jan. 15, establishing a unique code K1020 “Non-invasive vagus nerve stimulator.” The coding decision covers the company’s Gammacore Sapphire D.
Redwood City, Calif.-based Guardant Health Inc., a precision oncology company, and Vall d’Hebron Institute of Oncology (VHIO), a European cancer research organization, have agreed to enter a partnership to establish in-house liquid biopsy testing services, using Guardant Health’s industry-leading proprietary digital sequencing platform, at VHIO’s facility in Barcelona, Spain.
Gns Healthcare, a Cambridge, Mass.-based artificial intelligence-driven precision medicine company, reported a partnership with Hilden, Germany-based Qiagen. The parties will leverage Gemini – the in silico patient, across multiple cancers.
Hamilton Storage, of Franklin, Mass., and Rhinostics Inc., a Boston-based early-stage Harvard University spinout, reported the first step in a collaboration to improve decapping and accessioning of patient samples. The agreement includes joining Hamilton Storage’s Labelite Decapper with the Rhinostic swab collection device for hands-free and high throughput sample processing.
Newtown, Pa.-based Helius Medical Technologies Inc. said that it received written notice from the Nasdaq Stock Market LLC that the company’s minimum bid price deficiency has been cured, and that it is in compliance with all applicable listing standards.
Chicago-based Hillrom has entered a definitive agreement to buy Bardy Diagnostics Inc., a provider of ambulatory cardiac monitoring technologies headquartered in Seattle, for $375 million and future potential payments based on the completion of certain milestones. Hillrom is also acquiring net operating losses valued at more than $20 million that are expected to result in future tax benefits.
Integrated DNA Technologies Inc., of Coralville, Iowa, said it is developing a multiplex RT-qPCR test that can detect and distinguish between SARS-CoV-2, influenza A and influenza B in a single patient sample. The new Primetime SARS-CoV-2/Flu Test is being submitted to the U.S. FDA for emergency use authorization.
Menlo Park, Calif.-based Intersect ENT Inc. said CMS has approved a revised coding application filed by the company for its family of Propel (mometasone furoate) sinus implants used to reduce inflammation and maintain patency following sinus surgery. Previously, Propel shared a billing code with Intersect’s related but therapeutically distinct Sinuva (mometasone furoate) sinus implant, used to reduce polyps and the need for revision sinus surgery. The approval of the new application establishes a separate code for Propel, S1091 “Stent, non-coronary, temporary, with delivery system (propel),” and updates the Sinuva J-Code to J7402 “Mometasone furoate sinus implant, (sinuva), 10 micrograms.”
Rochester, Minn.-based Mayo Clinic Laboratories and American Hospital Dubai are partnering to improve advanced laboratory diagnostics in the Dubai region. Under the agreement, the two organizations will begin delivering laboratory testing through a collaboration based on of the hospital in early 2021.
San Diego-based Menon Biosensors Inc. said trials will advance on its Molecular Mirror platform technology in collaboration with the University of California San Diego School of Medicine. The trial aims to prove accuracy and feasibility as a rapid assay for detection of SARS-CoV-2 virus in patient specimens.
Haifa-based Mindup, Israel’s first dedicated digital health incubator, reported its 13th portfolio company, Cogme. The startup is developing an artificial intelligence-powered platform to reduce cognitive drops in populations, initially focusing on delirium, an acute condition that most commonly arises in inpatient settings.
Neovasc Inc., of Richmond, British Columbia, said it received a “not approvable” letter from the U.S. FDA regarding its PMA submission for the Neovasc Reducer. Neovasc CEO Fred Colen said the letter was “not unexpected, given the outcome of the [advisory] panel meeting.” The company is seeing approval of Neovasc Reducer for the treatment of refractory angina. The device is currently CE-marked for that indication.
Chicago-based Physiq Inc. said the National Cancer Institute and the National Institute on Biomedical Imaging and Bioengineering exercised their option to enter phase II of a multiphase contract to continue Physiq’s development of an artificial intelligence-based COVID-19 digital biomarker to address the rapid decompensation of high-risk COVID-19 patients. This exercise of phase II by the NIH brings the total contract to $6.6 million.
Sensorion SA, of Montpellier, France, reported preclinical data showing that the combination of tis SENS-401 molecule with cochlear implants reduced loss of residual hearing at a frequency located beyond the electrode array. SENS-401 also showed a statistically significant electrode impedance reduction.
South San Francisco-based Twist Bioscience Corp. has signed two biopharma technology agreements to enable novel therapeutics discovery. In collaboration with Serotiny Inc., of San Francisco, Twist aims to discover novel chimeric antigen receptors (CAR) for CAR T-Cell therapies. The agreement with Applied Stemcell Inc., of Milpitas, Calif., covers the use of its Targatt Cho Cell technology. Both agreements support and expand Twist’s capabilities for the discovery of antibody therapeutics.
Richland, Wash.-based Vivos Inc. said feedback received from the U.S. FDA on its breakthrough designation request for Radiogel has enabled it to hone its approach to its IDE application. Specifically, the company plans to complete animal testing to demonstrate the therapeutic benefits of Radiogel compared with the current standards of care for the thyroid tumor type prior to IDE submission, which is anticipated in early summer of 2021.