The FDA has designated Laminate Medical's VasQ™ External Support for the creation of arteriovenous fistulas (AVF) in hemodialysis patients as a Breakthrough Device.
The U.S. Food and Drug Administration and the National Telecommunications and Information Administration (NTIA) are launching a 120-day pilot to help reduce the availability of unapproved opioids illegally offered for sale online.
MNA nurses and healthcare professionals called for the halt of COVID-19 mask decontamination in April, finding lack of safety, efficacy evidence
New software can be used by pharma, biotech labs to comply with Title 21 CFR Part 11 data integrity regulations
Inspire Medical Systems CEO Tim Herbert has joined Nuvaira Board of Directors
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Illumina, Inc. for the first COVID-19 diagnostic test utilizing next generation sequence technology.
High-Definition PCR SARS-CoV-2 assay increases test throughput and reduces complexity of interpretation; ChromaCode customers enjoy inventory guarantee
Second FDA Approved Therapy for Neuromyelitis Optica Spectrum Disorder Offers Patients Additional Treatment Option
Virtual competition staged by National Capital Consortium for Pediatric Device Innovation (NCC-PDI) now accepting applications for devices addressing COVID-19 needs
U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation in a clinical trial was not feasible
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Drugs Pose Significant Risks to Patient Health and Violate Federal Law
Diagnostic tests are an important tool in anticipating and meeting the continuing and evolving public health needs as we combat COVID-19.
The durable, reliable, and low-cost ventilator is ideal for COVID-19 use in hospitals throughout the world.
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.
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.
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.
TSS is ready to decontaminate masks immediately.
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.