ENEXOR HEALTH SYSTEMS: Enexor Ventilators Granted FDA Emergency Use Authorization
The durable, reliable, and low-cost ventilator is ideal for COVID-19 use in hospitals throughout the world.
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FDA: Coronavirus (COVID-19) Update: Facilitating Diagnostic Test Availability for Asymptomatic Testing and Sample Pooling
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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FDA: Warns Four Manufacturers of Unapproved Injectable Drugs Labeled as Homeopathic
Drugs Pose Significant Risks to Patient Health and Violate Federal Law
FDA: Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine
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
CHILDREN'S NATIONAL HOSPITAL: FDA Grant and Gift from Entrepreneur Provide $250K in Awards for Pediatric Medical Device Competition Focused on COVID-19 Innovations
Virtual competition staged by National Capital Consortium for Pediatric Device Innovation (NCC-PDI) now accepting applications for devices addressing COVID-19 needs
FDA: Approves New Therapy for Rare Disease Affecting Optic Nerve, Spinal Cord
Second FDA Approved Therapy for Neuromyelitis Optica Spectrum Disorder Offers Patients Additional Treatment Option
CHROMACODE: FDA Issues Emergency Use Authorization for ChromaCode's High-Throughput HDPCR™ SARS-CoV-2 Real-Time PCR Assay
High-Definition PCR SARS-CoV-2 assay increases test throughput and reduces complexity of interpretation; ChromaCode customers enjoy inventory guarantee
FDA: Coronavirus (COVID-19) Update: FDA Authorizes First Next Generation Sequence Test for Diagnosing COVID-19
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.
NUVAIRA: Announces FDA Breakthrough Designation for AIRFLOW-3 Pivotal Trial Device
Inspire Medical Systems CEO Tim Herbert has joined Nuvaira Board of Directors
THERMO FISHER: Extends NanoDrop One/OneC Spectrophotometer to FDA-Regulated Companies
New software can be used by pharma, biotech labs to comply with Title 21 CFR Part 11 data integrity regulations
MNA: FDA Reversal on COVID-19 Mask Decontamination Follows MNA Opposition, Demonstrates Urgent Need for Implementation of Frontline Nurse and Healthcare Professional Guidance
MNA nurses and healthcare professionals called for the halt of COVID-19 mask decontamination in April, finding lack of safety, efficacy evidence
FDA: Federal Government Announces New Pilot Program to Help Stop Illegal Availability of Unapproved Opioids Online
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.
LAMINATE MEDICAL TECHNOLOGIES: VasQ™ External Support Awarded Breakthrough Device Designation by the FDA
The FDA has designated Laminate Medical's VasQ™ External Support for the creation of arteriovenous fistulas (AVF) in hemodialysis patients as a Breakthrough Device.
FDA: Coronavirus (COVID-19) Update: FDA Reissues Emergency Use Authorizations Revising Which Types of Respirators Can Be Decontaminated for Reuse
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.
CITIUS: Receives Positive FDA Feedback on Its Submitted Plan to Study Catheter Compatibility for Mino-Lok® Therapy
Compatibility plan includes testing representative samples of all commercially available CVCs and PIC
AAPS: Association of American Physicians & Surgeons (AAPS) Sues the FDA to End Its Arbitrary Restrictions on Hydroxychloroquine
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.
SEEK THERMAL: Seek Scan™ Becomes One of The Most Affordable Thermal Imaging Solutions Following FDA Guidelines During COVID-19 Public Health Emergency
CDC formally recommends daily health checks including temperature screening as U.S. businesses reopen
ACCESS MEDICAL: Announces Ultra Sonic Speed Results for SARS-CoV-2 Antibodies that is 100% sensitive and has an EUA from the FDA
The New 10 minute Antibody Test from Access Medical Labs sets a new standard after the CDC announced antibody testing may be wrong 50% of the time
WELLDOC: Receives FDA Clearance for Long-Acting Insulin Support for Award-Winning Digital Health Solution BlueStar®
Marks 8th FDA clearance for BlueStar, the only reimbursable software as a medical device for diabetes that integrates with all of a patient's existing devices
TRANSIT SCIENTIFIC: FDA Clears Innovative Angioplasty Scoring and Cutting Platform
New metal-alloy sheath converts angioplasty balloons into scoring and cutting systems