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. 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.
Also Celebrates 10-Year Anniversary of Invisible Hearing with Esteem® FDA Approval
Assay uses multiplexing for highly specific and sensitive detection of IgG antibodies against SARS-CoV-2
Bioventus, a global leader in orthobiologic solutions, is launching its SIGNAFUSE Bioactive Bone Graft in a new strip format.
Circadia Health announced today that it has received expedited FDA clearance for Contactless Respiration Rate (CResp®) monitoring due to COVID-19.
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.
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).
Enhanced performance and high throughput screening up to 384 samples simultaneously
Since the sudden onset of the COVID-19 pandemic the United States has faced a supply constraint of quality N95 masks.
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).
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
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. Food and Drug Administration has taken an additional step in harnessing real-world data to help inform the agency’s overall response to the COVID-19 public health emergency.
CLEWICU is the only device authorized by the FDA to provide early identification of patients who are likely to experience respiratory failure or hemodynamic instability, both potentially common but significant complications associated with COVID-19
U.S. Food and Drug Administration has taken an additional step in harnessing real-world data to help inform the agency’s overall response to the COVID-19 public health emergency.
TSS is ready to decontaminate masks immediately.
Frozen Wheels, a leading distributor of food and PPE, is announcing the opening of an office in Thailand in response to the growing demand for powder-free nitrile examination gloves.
Respira announces plans to pursue FDA authorization of the RespiRxTM drug delivery platform as the first vapor style inhalable Nicotine Replacement Therapy (NRT) designed to significantly increase cessation therapy effectiveness in the U.S.
Naviswiss AG, a medical technology company based in Denver, Colorado, with headquarters in Brugg, Switzerland, receives FDA Clearance on June 10, 2020, for their new navigation technology for hip replacement surgery.