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AirXpanders, Inc. (ASX: AXP), a medical device company focused on the design, manufacture, sale and distribution of the AeroForm® Tissue Expander System, announced that the company has submitted a Special 510(k) pre-market notification to the US Food and Drug Administration (FDA) for a Smooth Shell version of the AeroForm Tissue Expander System.
The Citizens Commission on Human Rights International (CCHR) raised concerns over the Food and Drug Administration approving the Monarch eTNS System for children 7-12 for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
FDA acting commissioner Norman Sharpless and deputy commissioner for food policy and response Frank Yiannas released a statement on the changes technology has made on how Americans receive their food.
Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative hematology solutions to drive better patient outcomes, announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the medical indication of its TEG® 6s Hemostasis Analyzer System for use in adult trauma settings.
US physicians and patient advocacy organizations expressed their overwhelming support for the FDA's suffix-based naming system for biologic medicines and biosimilars, according to comments electronically submitted last week to the agency.
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The U.S. Food and Drug Administration has posted warning letters to five companies who produce products labeled as homeopathic for significant violations of current good manufacturing practice (CGMP) regulations.
David Gortler, a professor of pharmacology and a former FDA official, says the FDA needs to do more to ensure the quality of drugs delivered to the U.S. market, with particular concern given to generic drugs produced in “sweatshop” countries.
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OrSense Ltd., a leading developer of systems for non-invasive measurements of Hemoglobin, today announces that its NBM200 non-invasive Hemoglobin measurement device has received FDA/CBER 510(K) clearance for use in blood banks
IDLogiq® innovations have been selected by the Food and Drug Administration (FDA) for the Pilot Project Program under the Drug Supply Chain Security Act (DSCSA) to prototype and develop a system that can address the national security of the drug supply chain and future interoperability of secure electronic information exchange.
Innovative external fixator shortens surgical time, simplifies inventory, and enhances patient care.
Two new medicines, Vyndaqel and Vyndamax, were approved for adults by the Food and Drug Administration earlier this month. They will help to treat heart disease caused by transthyretin mediated amyloidosis (ATTR-CM).
Children aged 6-17 with the autoimmune disorder Lambert-Eaton myasthenic syndrome (LEMS) have the first treatment for their disease with the Food and Drug Administration-approved Ruzurgi.
Congress should work on legislation allowing the FDA to fast-track the approval of some drugs already on the market in other developed countries, according to one researcher attached to a west coast free market think tank.
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eMurmur ID is an artificial intelligence-based solution that enables healthcare providers to detect and classify heart murmurs with expert-level accuracy
TraceLink Inc., the world's largest integrated digital supply network providing real-time information sharing for better patient outcomes, announced the acceptance of its participation in the Food and Drug Administration (FDA) Pilot Project Program under the Drug Supply Chain Security Act (DSCSA).
Citizensʼ Council for Health Freedom Media president Twila Brase says the current FDA drug approval process is too long and expensive.
Zebra Medical Vision (https://www.zebra-med.com/), the deep learning imaging analytics company, announces that it has received FDA 510(k) clearance for HealthPNX - an AI alert for pneumothorax (PNX), based on chest X-rays.
The number of U.S. measles cases confirmed this year reached 839 as of May 10, the highest level for any year since the nation declared the disease eliminated in 2000, according to the Centers for Disease Control and Prevention.
Soliton, Inc., (Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center ("MD Anderson"), provided an update on its application for FDA clearance and addressed a recent anonymous article published on SeekingAlpha.com.
Perrigo Company plc (NYSE; TASE: PRGO) announced its partner received final approval from the U.S. Food and Drug Administration for its AB rated Abbreviated New Drug Application (ANDA) referencing Voltaren® Gel, 1% (diclofenac sodium topical gel, 1%).