Bioelectronics Corp., of Frederick, Md., is partnering with Scott Specialties Inc., of Belleville, Kan., to bring its pain management devices to the retail consumer health care marketplace under Dallas-based Djo LLC’s Donjoy Advantage product line of orthopedic appliances. The new products will be marketed as an Eme Knee Wrap and Eme Back Wrap, powered by Bioelectronics’ drug-free Actipatch device.
Seattle-based artificial intelligence startup Careprotocol and Verida AS, a blockchain company headquartered in Viken, Norway, have launched Ikigai Network, a decentralized Openhealth ecosystem. The new information infrastructure will allow anyone to synchronize health data with a network of physicians, individuals, entrepreneurs and institutions.
Decision Diagnostics Corp., of Westlake Village, Calif., said it signed a number of distribution agreements for its Genviro! Covid-19 10.5 Second Saliva Swift Kits covering Puerto Rico, the Dominican Republic, the U.S. Virgin Islands and areas across the Caribbean and Central America. The announcement follows recent agreements covering Nigeria, Ivory Coast and Lebanon. The Genviro tests for COVID-19 are not yet available in the U.S. or Puerto Rico, but emergency use waivers are in process with the U.S. FDA, with additional submissions to occur in the near future, the company said.
St. Louis-based Genassist, a company associated with Saint Louis University, has inked an agreement with Patient Alerting Logistics (PAL), of Cincinnati, to track its implantable Musculus Wound Matrix muscle tissue regeneration device. Under the agreement, PAL will provide patient tracking and regulatory compliance data automation.
Hancock Jaffe Laboratories Inc. (HJLI), of Irvine, Calif., said the pre-IDE meeting with the U.S. FDA regarding the Venovalve U.S. pivotal trial has been set for Dec. 22. Topics to be discussed include Venovalve’s design and functionality, the trial protocol and the company’s nonclinical testing plan for the device. HJLI hopes to file its IDE application, incorporating feedback from the meeting, in the first quarter of 2021.
San Diego-based Mesa Biotech Inc. has been awarded a contact of up to $13 million from the Biomedical Advanced Research and Development Authority, part of HHS’ Office of the Assistant Secretary for Preparedness and Response, to develop Accula, a 30-minute, point-of-care test for the detection of SARS-CoV-2 and Flu A/Flu B in a single sample.
Orthoalign Inc., of Aliso Viejo, Calif., reported the first cases using its Lantern Surgical Assistant. The cases were performed by Michael Ast at the Hospital of Special Surgery in New York.
San Diego-based Progenity Inc. reported preliminary preclinical data supporting the potential of its oral drug delivery system (DDS) in targeting the colon. The study consisted of administering a fully functional DDS containing a mixture of acetaminophen and sulfasalazine in a canine animal model. The study endpoints were device function, as determined by evaluation of the data from the recovered capsules, and the pharmacokinetic (PK) results of the acetaminophen and 5-aminosalicylate drug products delivered using the DDS. According to Progenity, all devices met the study endpoints, and the PK results suggest that drug was released in the large intestine. No adverse events were observed.