As COVID-19 cases surge across the U.S., there is growing demand for greater access to testing to rein in the pandemic. On Wednesday, the U.S. FDA granted an emergency use authorization (EUA) to Abbott Laboratories for at-home use of the company’s Binaxnow COVID-19 Ag Card Home Test. Abbott has teamed up with Miami-based telehealth provider Emed to distribute and administer the tests, with an expected 30 million in the first quarter of 2021.
Using in vivo imaging technology, investigators at the University of Utah and the University of Padua have identified a new signaling mechanism for glutamate that was linked to the onset of spreading depression or spreading depolarization, a neuronal activity pattern that plays a role in multiple neurological disease states. In mouse models of migraine, glutamate, which is the major excitatory neurotransmitter of the brain, was released in what the authors called "plumes" or puffs.
Keeping you up to date on recent developments in diagnostics, including: Speeding triage of COVID-19 patients; New tests distinguishes COVID-19 and flu; Predicting heart failure; Expanding cryptosporidiosis testing in developing regions.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Concept Medical, Corvion, Miach Orthopedics.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biotheranostics, Neovasc, Pressure Biosciences, Stemina Biomarker Discovery.
New hires and promotions in the med-tech industry, including: Cytosorbents, Integrity Applications, Procept Biorobotics, Proximie, Sonde Health, Strive Health.
Bone Health Technologies Inc. may be on the verge of upstaging a common drug therapy, but don't tell them to break a leg. The San Francisco-based company's Osteoboost Vibration Belt received a U.S. FDA breakthrough designation for technology that delivers gentle stimulation to reduce bone loss and prevent osteoporosis with the goal of reducing the number of potentially devastating broken bones in the elderly.
Integra Lifesciences Holdings Corp. has entered a definitive agreement to acquire regenerative medicine-focused Acell Inc. for an up-front cash payment of $300 million and up to an additional $100 million upon the achievement of certain revenue growth milestones. The deal is expected to close in the first quarter of 2021, subject to the satisfaction of customary conditions. It also comes almost three months after London-based Smith+Nephew plc said it was going to pick up the extremity orthopedics business of Integra for $240 million in cash.
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