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.
The durable, reliable, and low-cost ventilator is ideal for COVID-19 use in hospitals throughout the world.
Diagnostic tests are an important tool in anticipating and meeting the continuing and evolving public health needs as we combat COVID-19.
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Drugs Pose Significant Risks to Patient Health and Violate Federal Law
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
Virtual competition staged by National Capital Consortium for Pediatric Device Innovation (NCC-PDI) now accepting applications for devices addressing COVID-19 needs
Second FDA Approved Therapy for Neuromyelitis Optica Spectrum Disorder Offers Patients Additional Treatment Option
High-Definition PCR SARS-CoV-2 assay increases test throughput and reduces complexity of interpretation; ChromaCode customers enjoy inventory guarantee
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.
Inspire Medical Systems CEO Tim Herbert has joined Nuvaira Board of Directors
New software can be used by pharma, biotech labs to comply with Title 21 CFR Part 11 data integrity regulations
MNA nurses and healthcare professionals called for the halt of COVID-19 mask decontamination in April, finding lack of safety, efficacy evidence
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.
The FDA has designated Laminate Medical's VasQ™ External Support for the creation of arteriovenous fistulas (AVF) in hemodialysis patients as a Breakthrough Device.
In response to public health and safety concerns about the appropriateness of decontaminating certain respirators, the agency is reissuing certain emergency use authorizations (EUAs) to specify which respirators are appropriate for decontamination.
Compatibility plan includes testing representative samples of all commercially available CVCs and PIC
The Association of American Physicians & Surgeons (AAPS) filed a lawsuit, AAPS v. FDA, against the Food and Drug Administration to end its arbitrary interference with the use of hydroxychloroquine (HCQ), which President Trump and other world leaders have taken as a prophylaxis against COVID-19.
CDC formally recommends daily health checks including temperature screening as U.S. businesses reopen