New York-based Aetion Inc. and Healthverity Inc., of Philadelphia, have launched Real-Time Insights and Evidence, a real-world evidence system to help researchers assess the safety and effectiveness of COVID-19 interventions.
Boston-based Akili Interactive Labs Inc. said its Endeavor digital attention treatment is available for use by children with attention deficit hyperactivity disorder, under the U.S. FDA’s COVID-19 enforcement discretion guidelines. The company is pursuing FDA clearance of the program as a prescription treatment in pediatric ADHD.
Aptargroup Inc., of Crystal Lake, Ill., and Shanghai-based Sonmol are teaming up to develop a digital platform for respiratory-related therapies, with an initial focus on connected drug delivery devices for asthma and chronic obstructive pulmonary disease. The partnership will work with pharma and health care partners to speed development, manufacturing, commercialization and supply of digital respiratory drugs, diagnostics and patient support services in China and other Asian markets for marketed and pipeline drugs.
Avacta Group plc, of Wetherby, U.K., said it has successfully produced several highly specific Affimer reagents that bind the SARS-CoV-2 viral antigen, as part of its collaboration with Cytiva to develop an Affimer-based rapid test for COVID-19. Based in Marlborough, Mass., Cytiva was previously GE Healthcare Life Sciences.
Bioclinica Inc., of Princeton, N.J., and Vivalnk Inc., of Campbell, Calif., reported the availability of a remote patient monitoring solution for pharmaceutical clinical trials. The tool combines Vivalnk’s wearable temperature sensor with Bioclinica’s information management platform to support cardiac safety services.
Redwood City, Calif.-based C3.ai reported the release of the C3.ai COVID-19 Data Lake for use in research related to the novel coronavirus.
The Austin-based Clinical Data Interchange Standards Consortium (CDISC) has released a free user guide to highlight data for studies pertaining to COVID-19, with examples on implementing CDISC standards for the novel coronavirus so that researchers can more effectively collect, structure and analyze data.
Cleveland-based Centerline Biomedical Inc. reported the receipt of a $1.5 million Phase II Small Business Innovation Research grant from the National Heart, Lung, and Blood Institute to advance development of its next-generation intra-operative positioning system (IOPS) image guiding technology. Centerline will use the funds to expand the IOPS platform to address peripheral vascular disease.
Atlanta-based Cotiviti Inc. has released its COVID-19 Outbreak Tracker to map potentially hidden “hot spots” of coronavirus across the U.S. The map leverages data from the company’s new Caspian Insights platform, an enriched, longitudinal repository of U.S. health care data.
Cytosmart Technologies, of Eindhoven, Netherlands, will donate 100 mini live-cell imaging systems to researchers in high containment labs worldwide. Labs working to combat COVID-19 are expected to benefit from this initiative, as Cytosmart aims to reduce the huge workload currently facing researchers on projects vital to controlling the disease.
Medley, Fla.-based Entopsis LLC entered a diagnostics commercialization agreement with Genetics Institute of America, of Delray Beach, Fla. The latter will create a laboratory-developed test based on Entopsis’ core diagnostic platform, Opsisdx. The purpose of the test will be to reduce or eliminate unnecessary prostate biopsies in men who are suspected of having prostate cancer.
Federated Healthcare Supply Holdings Inc., of Aston, Pa., acquired Cole Medical Inc., of Sykesville, Md. Cole Medical is a supplier of medical and surgical supplies and capital equipment to physician offices, ambulatory surgery centers and other alternate site health care providers in the Mid-Atlantic region. Financial terms of the transaction are not being disclosed.
Florio GmbH, of Munich, Germany, has launched Florio, a CE-marked digital medical device designed with the aim to improve the quality of life for people with haemophilia. Consisting of a smartphone app that can be combined with a wearable device and a web-based dashboard for physicians, Florio allows patients to track, monitor and share data relating to their health in real time with their health care teams to enable personalized care.
Icecure Medical, of Caesarea, Israel, entered an exclusive distribution agreement with Mts Medical Technology UG, of Konstanz, Germany. The agreement aims to accelerate commercialization of its CE-cleared, next-generation liquid-nitrogen-based cryoablation system, Prosense and its consumables, for the treatment of benign and malignant tumors in the fields of breast and interventional oncology, including kidney, bone and lung cancer, in Germany. The agreement will comprise Mts Medical's undertaking to purchase a minimum quantity of Prosense products and consumables to the value of €375,000 (US$406,033), paid no later than the end of March 2021.
Intraop Medical Corp., of Sunnyvale, Calif., reported the first patient enrolled in its Cosmopolitan Trial for breast cancer. The randomized, multicenter study will assess the safety and effectiveness of Intraop’s single treatment electron-beam intraoperative radiation therapy (IORT) delivered during surgery versus external beam radiation therapy delivered over three to four weeks.
Itamar Medical Ltd., which is based in Caesarea, Israel, with U.S. headquarters in Atlanta, reported the initiation of a trial that will evaluate the use of CPAP to manage patients with confirmed or suspected COVID-19. The study is a prospective, single-center, parallel group, open-label, randomized clinical trial to assess the efficacy of CPAP in 200 COVID-19 confirmed or suspected patients within the Mount Sinai Health System with respiratory symptoms who do not require hospital admission and are discharged home from the emergency room. The primary aim of the study is to determine if early, low, fixed CPAP at home reduces the risk of hospital/ER re-admission or death in COVID-19 confirmed or suspected patients.
Burlington, N.C.-based Labcorp said it will expand serological testing for SARS-CoV-2, the virus that causes COVID-19, to more hospitals and healthcare organizations.
Livanova plc, of London, said that several of its cardiopulmonary products are now permitted to be used in the U.S. for extracorporeal membrane oxygenation therapy greater than six hours per guidance issued by the U.S. FDA April 6 to temporarily expand the availability of devices to address the COVID-19 pandemic.
Maccabi Healthcare Services, an Israeli health maintenance organization, reported the deployment of a new artificial intelligence-powered algorithm that identifies individuals estimated to be at the highest risk of severe COVID-19 complications due to pre-existing conditions and other health factors. The algorithm was developed by Medial Earlysign, of Tel Aviv, Israel, and the Kahn-Sagol-Maccabi Research and Innovation Institute.
Medtronic plc, of Dublin, said it continues to expect COVID-19 to negatively affect its fiscal fourth quarter financial results, which ends April 24. Given the progression of COVID-19 around the world and the timing of the company’s fiscal quarter. Medtronic’s fourth quarter financial results will reflect an additional month of impact compared with many other companies who operate on a calendar-based fiscal year.
Mississauga, Ontario-based Microbix Biosystems Inc. said that it has attained medical devices establishment licensing from Health Canada, enabling the immediate usage of its quality assessment products by clinical laboratories.
Milestone Scientific Inc., of Livingston, N.J., said it has validated and integrated the new Cathcheck feature into the Compuflo Epidural system. Using Cathcheck, physicians and nurses can monitor the placement of a catheter to determine the presence or absence of a pulsatile waveform, providing new information that can be used to determine if the catheter is in place or has become dislodged from the epidural space.
Mimedx Group Inc., of Marietta, Ga., an advanced wound care company, received notice from Bank of America that its application for a Paycheck Protection Program (PPP) under the CARES Act has been approved. The company expects to receive the funds from the PPP loan by the end of the April. In addition, the company has agreed to terms for an amendment to its loan agreement, dated as of June 10, 2019, with Blue Torch Finance LLC to modify certain covenant terms in the original Term Loan Facility. Both the PPP Loan and the Blue Torch amendment would provide the company with the additional capital and financial flexibility needed to support business operations during the current economic period. The PPP loan application was for the maximum $10 million available under the program.
Nexa3D, of Ventura, Calif., reported the launch of a service to deliver 3D-printed Nexashield personal protective equipment for health care and other essential workers on the frontline.
Nuritas Ltd., of Dublin, received a grant of an unreported amount from Partnership for Advanced Computing in Europe for COVID-19 research. Under the terms of the grant, Nuritas will employ its artificial intelligence platform to identify peptides with antiviral properties as well as peptides with cytokine regulatory properties, with the goal of creating a therapeutic ‘peptide cocktail.’ If successful, this approach has the potential to slow or stop disease progression by both mitigating viral replication and modifying the cytokine-based inflammatory response known to drive respiratory damage in patients with COVID-19.
Software company Qualtrics LLC, of Provo, Utah, said the State of Iowa will leverage its COVID-19 Assessment, Testing, and Case Management Solution. The online assessment provides the ability to screen residents based on risk, prioritize who needs to be tested, route those individuals to testing sites and manage the spread of the virus throughout the state.
Quotient Ltd., of Eysins, Switzerland, reported performance data for its SARS-CoV-2 antibody test. In interim study results using greater than 160 samples for the Mosaiq COVID-19 Antibody Microarray, sensitivity was 100% and specificity was 95%. Based on these results, under applicable regulations, the company can now offer the antibody test as a research-use-only product in Europe and the U.S.
Sono-Tek Corp., a Milton, N.Y.-based developer of ultrasonic coating systems, said it was approved for a $1,001,640 Paycheck Protection Program loan under the U.S. CARES Act.
Trividia Health Inc., of Fort Lauderdale, Fla., launched the SARS-CoV-2 Antibody Test kit, a rapid, point-of-care test that can qualitatively detect IgM and IgG antibodies against the virus that causes COVID-19. The whole-blood-based test provides patients results within 20 minutes. The company said it is also working on a molecular diagnostic test.