Cue Health Inc. rolled out a same-day, at-home, test-to-treatment program through its Cue Health app for any patient in the U.S. with a positive result from its COVID-19 test. The service includes a virtual, on-demand visit with a health care professional to discuss the test result; a prescription for medication to treat the virus, if appropriate; and home delivery of the medication, typically within hours of the visit. Medications may also be made available for pickup at a local pharmacy.
The Charles Stark Draper Laboratory Inc. has joined forces with the U.S. Department of Defense (DoD) to screen pathogens, toxins and diseases using its high-throughput organ-chip devices. As part of a concerted effort to develop new medical countermeasures against biological and chemical threats, organs-on-a-chip provide directly applicable insights into human responses and enable testing on organs developed from a diverse pool of live donors prior to human trials.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avenda, Bodyport, Bot Image, Cerevasc, Imspex Diagnostics, Medalliance, Neuroone.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Genbody, Vieworks, Wision.
Bio-Rad Laboratories Inc. signed a $170 million deal to acquire all the outstanding shares of molecular diagnostics subsidiary Curiosity Diagnostics SpZoo from Scope Fluidics SA. The deal consists of approximately $100 million in cash and up to $70 million in future milestone payments. The pre-commercial platform company is the developer of a CE-marked 15-minute point-of-care (POC) rapid PCR system which tests for SARS-CoV-2 virus and methicillin-resistant or-sensitive Staphylococcus aureus bacteria (MRSA/MSSA).
Legislation that would renew the U.S. FDA’s user fee programs is stuck in process on Capitol Hill, a predicament that seems to resist resolution to date. FDA commissioner Robert Califf said on a July 12 webinar that the FDA “is a decision-making machine” that is reliant on both user fees and congressional appropriations, and that a failure on the part of Congress to act on user fee legislation may force the agency to halt new hires and possibly lay off some FDA staff.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Empowered Diagnostics.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Dexcom, Electrocore, Laseroptek, Medial Earlysign, Reflexion, Roche, Zillion.