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Lucira Health has developed an at home COVID-19 test kit that delivers PCR quality molecular accuracy in the palm of your hand in 30 minutes or less. Our technology is transforming how we reduce the spread of infectious diseases by bringing accurate, easy-to-use self-testing into the home. This home test kit has not been FDA cleared or approved. This home test kit has been authorized by FDA under EUA. This home test kit has been authorized only for the testing of nasal swabs for detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This home test kit is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of IVDs for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or revoked sooner.
Mentor Corporation is one of the leading companies in the Healthcare, Pharmaceuticals, and Biotech sector.
Hermann Medical Supply is a Houston, TX-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
Palette Life Sciences is a fully integrated medical device company providing a wide range of products and services that improve quality of life of patients. Our portfolio of products focuses on treating conditions in urology/urogynecology disorders, colorectal conditions, radiotherapy, and interventional oncology procedures. For physicians, researchers, and inventors alike, progress begins with a natural curiosity and the drive to do more. By discovering and applying new applications of proven medicine to uncommon, or difficult to treat conditions, we can address the needs of patients often overlooked by traditional medical companies. Inspired by innovation and empathy, we see endless possibilities in expanding on proven technologies to elevate patient care. The foundation for all of our breakthrough products is Non-Animal Stabilized Hyaluronic Acid (NASHA®). NASHA has been proven safe and effective for more than two decades in over 50 million medical procedures worldwide. Barrigel® - the first and only FDA-cleared hyaluronic acid rectal spacer, minimizing the side effects of radiation therapy for prostate cancer patients. Barrigel is available in the US, Australia and Europe. Deflux® - the only FDA-approved injectable treatment for vesicoureteral reflux (VUR), a urinary defect that affects 1% of children worldwide. Deflux for VUR is available in the US, Canada, Europe, Japan, Latin America, Australia and New Zealand. Also indicated for stress urinary incontinence (SUI) in women, Deflux for SUI is available in Canada and Europe.
Bardy Diagnostics, Inc. (bardydx.com) has created a new, state-of-the-art heart monitor known as Carnation Ambulatory Monitor (CAM™) that can be worn comfortably and discreetly for up to 7 days. Unlike many other heart monitors, CAM™ can be worn during exercise or while showering. Its unique, narrow, hourglass shape makes it especially advantageous for the female anatomy. Developed on the principle that non-invasive cardiac monitoring should provide an excellent quality atrial signal, the CAM is designed to be placed along the sternum—over the heart— to optimize P-wave signal capture. The result is improved ECG resolution, providing more information about the heart rhythm which may lead to more clinically actionable diagnoses.