GEL-E, INC.: Breakthrough Device Designation received from the FDA
gel-e Inc., announces Breakthrough Status Designation from the U.S. Food and Drug Administration (FDA) for its first internal-use flowable device.
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ZEBRA MEDICAL VISION: Third FDA Clearance for Zebra-Med's AI Solution for Brain Bleeds Alerts
Zebra Medical Vision (https://www.zebra-med.com/), the deep learning medical imaging analytics company, announces today that it has received its third FDA 510(k) clearance for the company's HealthICH product - an AI alert for intracranial hemorrhage (ICH), based on head CT scans.
CARSGEN THERAPEUTICS: Receives IND Clearance for BCMA-CAR-T Cells from the U.S. FDA
CARsgen Therapeutics, a clinical-stage company committed to developing Chimeric Antigen Receptor T cell therapies for cancer, announced that one of its leading drug candidates, CT053 fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell for the treatment of patients suffering from relapsed/refractory multiple myeloma (rrMM), has received Investigational New Drug (IND) clearance from the United States Food and Drug Administration (FDA).
Physician praises FDA plans to further assist doctors obtain experimental cancer treatments
WASHINGTON, D.C. -- A physician has applauded a new FDA program that aims to simplify the process doctors use to offer non-approved cancer treatments to patients.
BIO-TECHNE CORPORATION: FDA Grants Breakthrough Device Designation To Bio-Techne's ExoDx™ Prostate IntelliScore™ (EPI) Test
Bio-Techne announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its ExoDx Prostate IntelliScore (EPI) test, making it the first exosome-based liquid biopsy test to receive a Breakthrough Device Designation.
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COHLEAR LIMITED: FDA approves new cochlear implant with easier access to MRI and expanded connectivity ready for Google's direct streaming to Android smartphones
Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, today announced the U.S. Food and Drug Administration's (FDA) approval of the new Cochlear™Nucleus® Profile™ Plus Series Cochlear Implant and the Nucleus 7 Sound Processor's new built-in connectivity featuring direct streaming with compatible Android™ smartphones.
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ARATANA THERAPEUTICS: Granted FDA Approval of NOCITA® (bupivacaine liposome injectable suspension) 10 mL Vial
Commercial availability of NOCITA 10 mL vial size anticipated by fall 2019
EMCYTE CORPORATION: Announces FDA 510(k) Clearance for its PureBMC® Supraphysiologic Concentrating System
EmCyte, is proud to announce that it has received FDA 510(k) clearance for its PureBMC® Supraphysiologic Concentrating System.
Emerging biotech firms rival big pharma in new drug development, study finds
Emerging biotech companies developed nearly two-thirds of the new drug therapies approved last year in the United States, according to a new study by the pharmaceutical research company Iqvia.
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METVITAL, INC.: Announces FDA Clearance of Investigational New Drug (IND) Application for AEO for Phase 2 testing for Glioblastoma Multiforme
MetVital, Inc., a biopharmaceutical company developing small molecule modulators of glutamate metabolism for the treatment of diseases with significant unmet medical need and commercial potential, announces that the U.S. Food and Drug Administration (FDA) has notified MetVital that it may proceed with its clinical investigation of "Anhydrous Enol-Oxaloacetate" (AEO) as a potential treatment for patients with Glioblastoma Multiforme.
AIDOC: AI for C-Spine Fractures: Aidoc Sets the Pace With 3rd FDA Clearance in 9 Months
Aidoc's solution ensures patients with C-spine fractures are treated faster, saving lives
FDA OK'd 481 drugs in May
The U.S. Food and Drug Administration approved 481 drug products in May, according to an online list the agency updated this week.
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R3 STEM CELL: Responds to FDA Letter to Reaffirm its Commitment to Public Health and Safety
R3 Stem Cell, LLC (R3), a leader in regenerative therapy practices, issued a formal response to a letter it received from the FDA that raised concerns over alleged unapproved stem cell products to treat a variety of diseases and conditions as well as potential safety concerns.
AKONNI BIOSYSTEMS INC.: Receives FDA 510(k) Clearance of Its TruDiagnosis Multiplex Diagnostic System
FDA clearance is part of Company's three-part strategy to change the business paradigm for the molecular diagnostic industry
R3 Stem Cell receives letter from FDA over unapproved products
R3 Stem Cell and CEO David Green received an untitled letter from the Food and Drug Administration (FDA) for unapproved stem cell products offered at its more than 50 centers around the U.S.
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ZAVATION: Gains US FDA Clearance for the Ti3Z Interbody System (TLIF, T-PLIF, and PLIF)
Zavation, an employee-owned medical device company that designs, develops, manufactures and distributes medical device products, announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market the Ti3Z Interbody System (TLIF, T-PLIF, and PLIF).
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W. L. GORE & ASSOCIATES: GORE® CARDIOFORM ASD Occluder Receives FDA Approval for the Treatment of Atrial Septal Defects
Data from the Gore ASSURED Clinical Study demonstrated 100 percent closure success at six months