Medakit Ltd, a leading biotech company specialized in the production of antibody diagnosis tests for COVID-19, received on June 10th a warning letter from the Food and Drug Administration outlining their concern regarding the terminology utilized in Medakit website allegedly suggesting the use of Medakit test for "home-use" settings.
U.S. Secretary of Agriculture Sonny Perdue and FDA Commissioner Stephen M. Hahn, M.D., issued the following statement regarding food export restrictions pertaining to COVID-19
Allergan, an AbbVie Company (NYSE: ABBV), and Molecular Partners (SIX: MOLN), a clinical-stage biotechnology company developing a new class of custom-built protein therapeutics known as DARPin® therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter to the Biologics License Application (BLA) for Abicipar pegol, a novel, investigational DARPin® therapy for patients with neovascular (wet) age-related macular degeneration (nAMD).
Since the sudden onset of the COVID-19 pandemic the United States has faced a supply constraint of quality N95 masks.
Enhanced performance and high throughput screening up to 384 samples simultaneously
The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for a rapid COVID-19 antibody test distributed by Virality Diagnostics LLC, manufactured by Biohit (Hefei).
Companion Medical, manufacturers of InPen, the only FDA-cleared smart insulin pen system, announced that they received FDA expanded clearance for all ages* to use the InPen System.
Circadia Health announced today that it has received expedited FDA clearance for Contactless Respiration Rate (CResp®) monitoring due to COVID-19.
Bioventus, a global leader in orthobiologic solutions, is launching its SIGNAFUSE Bioactive Bone Graft in a new strip format.
Assay uses multiplexing for highly specific and sensitive detection of IgG antibodies against SARS-CoV-2
Also Celebrates 10-Year Anniversary of Invisible Hearing with Esteem® FDA Approval
The U.S. Food and Drug Administration took important action to help facilitate the timely development of safe and effective vaccines to prevent COVID-19 by providing guidance with recommendations for those developing COVID-19 vaccines for the ultimate purpose of licensure.
LivsMed Inc. receives 510(k) clearance from the FDA for its ArtiSential™ articulating bipolar energy instruments for electrosurgical cutting and coagulation. ArtiSential™ devices feature the patented, double-jointed end effector, which allows surgeons to overcome the challenges presented by difficult angles of approach, especially in complex procedures.
The U.S. trial for CE-marked CBSO is designed to enroll up to 250 patients in a staged study approach
Engage Surgical, a privately held orthopedic implant company, announces FDA 510(k) clearance of the only cementless partial knee system available in the USA.
Kroger Health's new testing model combines at-home convenience with telehealth technology, with most results confirmed in less than 72 hours
At-home test by Phosphorus will reduce commute to testing centers and help companies conduct tests for their employees
As part of continued action to protect the American public, the U.S. Food and Drug Administration is warning consumers and health care professionals about hand sanitizer products containing methanol, or wood alcohol — a substance often used to create fuel and antifreeze that is not an acceptable active ingredient for hand sanitizer products and can be toxic when absorbed through the skin as well as life-threatening when ingested.
In a phase III study, a majority (60%) of heavily treatment-experienced adults randomized to receive Rukobia with an optimized background therapy achieved and maintained viral suppression through 96 weeks, addressing a critical unmet need
Soterix Medical Inc. announces it has received FDA Investigational Device Exception (IDE) to launch a trial of transcranial Direct Current Stimulation-Limited Total Energy (tDCS-LTE) neuromodulation at-home for patients with Major Depressive Disorder (MDD).