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. Read More
Alphatec Holdings Inc. has renewed a commitment to buy Eos Imaging SA, saying it will now pick up the company for $79.7 million, plus the retirement of $37.2 million in debt, in an all-cash deal. Both company’s boards have approved the execution of a tender offer agreement, through which Carlsbad, Calif.-based Alphatec will launch a cash tender offer for all the issued and outstanding shares and convertible notes of Eos imaging for a total purchase price of $116.9 million. Read More
The U.S. FDA granted a breakthrough device designation to Exero Medical Ltd.’s implantable smart sensor for early detection of anastomotic leaks after gastrointestinal (GI) surgery. The device continuously monitors the GI tract near the surgical site to alert providers about potentially deadly leaks. Read More
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. Read More
HONG KONG – A new prototype hand-held device coupled with an artificial intelligence (AI)-powered app could make it possible for women to screen for breast cancer at home cheaply and efficiently. The device, the Blue Box, is the brainchild of Judit Giro? Benet, a 23-year-old junior specialist at the Center for Embedded Cyber-physical Systems at the University of California, Irvine, who is working with her Taiwanese partner Billy Chen to get their Blue Box to market. Read More
New hires and promotions in the med-tech industry, including: Cytosorbents, Integrity Applications, Procept Biorobotics, Proximie, Sonde Health, Strive Health. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biotheranostics, Neovasc, Pressure Biosciences, Stemina Biomarker Discovery. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Concept Medical, Corvion, Miach Orthopedics. Read More
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. Read More
