The Carestart COVID-19 Antigen test kit developed by Somerset, N.J.-based Access Bio Inc. has been launched in the U.S.
Laguna Hills, Calif.-based Amplify Surgical Inc. reported the launch of the Dualx T/Plif 12-Degree hyperlordotic interbody cages. Nima Salari, of Scottsdale Ariz., became the first spine surgeon to implant the new interbody cage at Honor Shea Health.
Rostock, Germany-based Centogene NV and Alnylam Pharmaceuticals Inc., of Cambridge, Mass., reported the launch of a new joint clinical screening program: the genetic screening of the at-risk population for hereditary Transthyretin-related Amyloidosis and longitudinal monitoring of TTR-positive subjects.
Kansas City, Mo.-based Cerner Corp. reported an investment in Elligo Health Research, an Austin, Texas-based research organization that enables clinical trials with nationwide community-based health care practices. Cerner representatives also will join Elligo’s board. As a result of this investment, Cerner plans to enter a commercial agreement to expand the data and tools available in the Cerner Learning Health Network to offer additional clinical trial resources to community and rural hospitals and physician practices. This collaboration is expected to help accelerate clinical research timeframes, make clinical trials more broadly and easily accessible and reduce the costs associated with bringing a therapy to market. Financial terms were not disclosed.
Compugroup Medical US, of Phoenix, is acquiring Schuyler House, an established developer of laboratory information systems with headquarters in Valencia, Calif. No financial details were disclosed. Compugroup Medical US is the North American division of Compugroup Medical SE & Co. KGaA, of Koblenz, Germany.
Boston-based Emulate Inc., which provides in vitro models, said that its Alveolus Lung-Chip is being used by the U.S. Army to understand how the SARS-CoV-2 virus interacts with lung cells.
Hilco Streambank, part of Northbrook, Ill.-based Hilco Global, is marketing for sale patents for devices and techniques related to surgical treatments for mitral regurgitation and atrial fibrillation (AF), including nine issued patents. Hilco Streambank brought this patent portfolio to market in 2019 as part of the receivership of Lc Therapeutics Inc. and facilitated a sale to a creditor of the company. These assets are again available for sale, along with a newly issued AF patent. Offers to acquire some or all of the patents are due by Jan. 5, 2021. Interested parties should submit their final offers by the deadline, as there will not be a further round of bidding or an auction following that date.
Illumina Inc., of San Diego, and Harvard Pilgrim Health Care unveiled a risk-sharing agreement to make whole-genome sequencing available to certain Harvard Pilgrim members, effective Jan. 1, 2021.
San Francisco-based Ixlayer Inc. reported that its technology was selected by the Chan Zuckerberg Biohub and Stanford University to power the Community Alliance to Test Coronavirus at Home (CATCH) Study, a large-scale research collaboration led by Stanford Medicine for testing and tracking the coronavirus throughout the greater San Francisco Bay Area.
JDRF, of New York, has launched a screening initiative for type 1 diabetes (T1D): T1Detect. Designed to make early detection of T1D easier and more accessible to a broad population, financial assistance is available for the cost of the screening. The initiative is supported by founding sponsor Provention Bio Inc., of Red Bank, N.J.
Liquid Diagnostics, of San Clemente, Calif., reported the development and successful CLIA validation of a home-collection assay for the quantitative testing of COVID-19 antibodies using saliva.
Berlin-based Magforce AG reported the completion of installation of the new Nanotherm treatment center for patients with brain tumors at the Hufeland Clinic in Mühlhausen, Thuringia, Germany. The treatment of brain tumor patients is expected to begin this month.
Neuronetics Inc., of Malvern, Pa., said it has amended its term loan agreement with its current lenders, investment affiliates managed by Solar Capital Partners LLC (Solar). The amendment includes the resetting of certain revenue covenants, and the dividing of the second tranche of the term loan, originally $15 million, into three separate $5 million tranches.
Nowdiagnostics Inc., of Springdale, Ark., said that study results for its Adexusdx COVID-19 antibody test showed 100% sensitivity and specificity in a well-characterized 45-sample panel of COVID-19 positive and negative samples, provided by the Biodefense and Emerging Infections Research Resources Repository. The test was submitted to the U.S. FDA for emergency use authorization in May. The application is still pending.
Richardson, Texas-based Orb Health Inc. is partnering with Anelto Inc., of The Colony, Texas, which focuses on remote patient monitoring (RPM) solutions. The result is an enterprise RPM, alert and dynamic response solution that aims to fulfill the connected patient vision and empower a new level of patient data that allows the clinical team to respond quickly and keep patients more involved with their health care.
Peijia Medical Ltd., of Suzhou, China, said it has successfully commenced the animal experiment for its mitral valve edge-to-edge repair product, advancing development to the next stage.
Boca Raton, Fla.-based Sensus Healthcare Inc. said CMS has issued a new, final reimbursement rate for CPT code 77401 of approximately $41 per treatment. This code covers the delivery of Superficial Radiation Therapy (SRT), and the new amount represents a 66% increase from current levels.
Mississauga, Ontario-based Skylight Health Group Inc. has entered a remote care services agreement with Gathermed, of New Orleans, to provide Skylight patients with remote patient monitoring tools and services for patients with hypertension.
Linköping, Sweden-based SyntheticMR AB said its SyMRI can be integrated in Tokyo-based Fujifilm’s picture archiving and communication software (PACS) solution, Synapse, as an opt-in available to their customers in Japan.
Tae Life Sciences (TLS), of Foothill Ranch, Calif., reported a joint venture agreement with Neuboron Medtech Ltd., of Nanjing, China, for the widespread adoption of accelerator-based boron neutron capture therapy (AB-BNCT) for the treatment of invasive, recurrent and difficult to treat cancers. Under the agreement, TLS becomes the second shareholder in Neuboron Therapy System, originally a wholly owned subsidiary of Neuboron.
New York-based Target ALS has launched a comprehensive research effort to discover biomarkers for amyotrophic lateral sclerosis (ALS). Through The Target ALS Diagnosis Initiative, the organization will invest $15 million in collaborative grantmaking and the development of new scientific resources. The initiative will focus on three areas: establishing new ALS biomarker-focused collaborative funding opportunity; creating a five-year natural history study; and developing an integrated biofluid and genomics core that will help to advance the impact of human biosamples on research.
Croissy Beaubourg, France-based Theradiag SA, which focuses on in vitro diagnostics and theranostics, has obtained a €1.9 million (US$2.3 million) state-guaranteed loan from a bank syndicate.
Paris-based digital therapeutics company Tilak Healthcare SAS has inked an agreement with Novartis Pharma AG, of Basel, Switzerland, for the promotion internationally of Tilak’s first clinically validated mobile app for patient remote vision monitoring, Odysight.
Aliso Viejo, Calif.-based Vertos Medical Inc. reported that the Centers for Medicare & Medicaid Services (CMS) has increased Ambulatory Surgery Center (ASC) reimbursement for the Mild procedure. Effective Jan. 1, 2021, the national average ASC reimbursement for CPT 0275T will increase by 41%, from $2,803.35 to $3,941.14, in recognition of the device cost associated with the procedure.
Plano, Texas-based Vitaltech, a provider of fully integrated digital health solutions, reported a partnership with Chesterfield, Mo.-based Medigroup. Vitaltech will provide its remote patient monitoring solution to Medigroup’s 30,000 member organizations.
Columbia, Md.-based Welldoc Inc. reported the launch of a new behavioral health offering designed to help users develop skills to solve real-world problems in a structured way. The strategies adapted for use in the offering were derived from clinical knowledge and years of experience building award-winning digital health solutions for diabetes, hypertension, heart failure and diabetes prevention. The new behavioral health program will be available as part of Welldoc’s single platform offering for chronic condition and population health management.