OKAMI MEDICAL: Announces Major Milestones: FDA 510(k) Clearance And Key Patent For The LOBO Vascular Occluder
Microcatheter-delivered device designed to provide rapid and focal occlusion of a wide range of peripheral arterial targets
Microcatheter-delivered device designed to provide rapid and focal occlusion of a wide range of peripheral arterial targets
Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today announced that the U.S. Food and Drug Administration (FDA) will hold a Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting in connection with its review of the pending New Drug Application (NDA) for Brinavess™ (vernakalant hydrochloride, IV).
Phase 1 clinical study in patients with advanced malignancies expected to begin in early 2020
A new partnership between CEFALY Technology and QB Medical puts wearable medical devices in the hands of health care providers and grants active military immediate relief from migraine headaches
Former U.S. Food and Drug Administration (FDA) commissioner David Kessler drew attention last week when he said he thought Juul and other popular vaping manufacturers would be forced to leave the market under proposed FDA rules.
All amounts in this release are in conformity with U.S. generally accepted accounting principles ("GAAP").
The U.S. Food and Drug Administration (FDA) has awarded AnaBios an exclusive Indefinite Delivery Indefinite Quantity (IDIQ) contract to employ adult human primary tissues and cardiomyocytes from organ donors to assess drug safety related to cardiac function.
Innovative ventilation system that can be used across health care settings for full range of patients
Camurus AB (NASDAQ STO: CAMX) announces that the U.S. Food and Drug Administration (FDA) has granted Camurus' US partner Braeburn's request (through Citizen Petition) to revoke orphan drug designation of Sublocade™.
UVision360 Inc., creators of the patented LUMINELLE® DTx Hysteroscopy System, announced the 510(k) clearance and launch of the latest addition to the LUMINELLE line, the 3mm LUMINELLE® Dx 360˚ Rotatable Disposable Sheath (Diagnostic).
AI Medical Service Inc., one of the world's first real-time endoscopic artificial intelligence (AI) developers, today announced the Company has secured Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its AI programs that analyze endoscopy images for potential diagnosis of gastric cancer.
IRRAS, a global healthcare company with a comprehensive portfolio of innovative products for neurocritical care, announced today that the US FDA has cleared a new 510(K) for IRRAflow.
At the U.S. Food and Drug Administration we continue to closely monitor the supply chain effects of closures and potential closures of specific large-scale sterilization facilities that use a gas called ethylene oxide to sterilize certain medical devices prior to their use.
Violations include marketing unapproved new human and animal drugs, selling CBD products as dietary supplements, and adding CBD to human, animal foods
The U.S. Food and Drug Administration announced that recently Golden Gate Soy Products, a California-based food manufacturer, has agreed to discontinue selling food products until the company complies with federal regulations and other requirements.
Clinic had significant donor eligibility violations, including donor screening and testing
International medical imaging IT and cybersecurity company Sectra (STO: SECT B) and Leica Biosystems announce collaboration for an integrated clinical pathology solution.
Innovent Biologics, Inc. ("Innovent" or "the Company") (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, announced that the new drug application ("NDA") submitted by Incyte to the U.S. Food and Drug Administration ("FDA") for pemigatinib in previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements has been accepted for Priority Review by FDA.
Today, the U.S. Food and Drug Administration authorized marketing of a new diagnostic test based on bacterial viability and novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization, a widespread cause of hospital-acquired infections.
New FDA Approval Extends Label to Including the i:X's Detection of Bacteria and Digital Wound Measurement