Doctors disagree on FDA approach toward stem cell treatments
WASHINGTON -- The New York Times recently published a lengthy story about stem cell treatments, describing the Food and Drug Administration’s approach as industry friendly.
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LEICA BIOSYSTEMS: Receives FDA 510(k) Clearance to Market a Digital Pathology System for Primary Diagnosis
Leica Biosystems, the global leader in pathology workflow solutions, announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Aperio AT2 DX System for clinical diagnosis in the U.S.
CEPHEID: Receives FDA Clearance for Extragenital Claims for Xpert® CT/NG Test
On-Demand Same-Day Extragenital Testing for Chlamydia and Gonorrhea Fills Critical Unmet Need in Fight Against Rising Rates of Chlamydial and Gonorrheal Infection
LUYE PHARMA: Luye Pharma's Rykindo® NDA Filing Accepted by the U.S. FDA
Rykindo® (LY03004), Luye Pharma's innovative, independently developed Extended-Release Microspheres formulation for injection, is one step closer to going on the U.S. market.
MEDIVIS: Wins FDA Clearance for Breakthrough Augmented Reality Surgical System
SurgicalAR™ Officially Brings Holographic Visualization into the Operating Room
New gene therapy to be world’s most expensive drug at $2.1M
Zolgensma, a gene therapy to treat spinal muscular atrophy (SMA) in infants, will be the world’s most expensive drug at $2.1 million.
Iowa congressman praises FDA's decision to extradite treatment for woman battling rare form of ALS
U.S. Rep. Steve King (R-Iowa) praised the Food and Drug Administration for its decision to speed up treatment for a 25-year-old Iowa woman battling amyotrophic lateral sclerosis, or Lou Gehrig’s disease.
INOVA DIAGNOSTICS: QUANTA Flash RF IgM and IgA receive FDA clearance
Inova Diagnostics, a world leader in autoimmune disease diagnostic systems and reagents for the clinical laboratory, is pleased to announce the 510(k) clearance of QUANTA Flash® Rheumatoid Factor (RF) IgM and QUANTA Flash RF IgA assays by the US Food and Drug Administration (FDA).
COTA, INC.: Signs Research Collaboration Agreement With The U.S. Food and Drug Administration
Collaboration Aims to Study Variation in Cancer Treatment Patterns by Extracting and Analyzing Real-World Data
NOVADOZ PHARMACEUTICALS: MSN Labs/Novadoz Pharmaceuticals receives consecutive FDA approvals for their generic versions of Solifenacin and Trientine
It was a very significant week for Novadoz Pharmaceuticals, the U.S sales & marketing affiliate of The MSN Group (MSN) based in Hyderabad, India.
SOLITON, INC.: Receives FDA 510(k) Clearance of its Acoustic Shockwave RAP Device
Soliton, Inc., (Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center ("MD Anderson"), announced that it has received clearance from the U.S. Food & Drug Administration ("FDA") to market its Rapid Acoustic Pulse ("RAP") device for tattoo removal.
CONTROLRAD, INC.: Announces FDA Clearance and Launch of the Only Radiation Reduction Technology that Integrates into Mobile C-arms
The ControlRad Trace solution reduces unnecessary radiation up to 89%, protecting patients and medical staff without compromising image quality or workflow.
REGENXBIO: Announces First FDA Approval of a Gene Therapy Based on Its Proprietary NAV® Technology Platform
FDA approval of Novartis' ZOLGENSMA for the treatment of pediatric patients with SMA marks the first regulatory approval based on REGENXBIO's NAV Technology
EPIBONE, INC.: Receives FDA Clearance to Commence its First-In-Human, Phase 1/2 Trial of its Bone Product, EB-CMF
Potential breakthrough technology for stem-cell based bone replacement
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THINK SURGICAL, INC.: Submits to the U.S. FDA for Clearance to Market its Active Robot for use in Total Knee Replacement Procedures
THINK Surgical, Inc. ("THINK") announces completion of enrollment for the U.S. investigational clinical study and submission of the 510(k) to obtain clearance from FDA to market its active robot, TSolution One®, for use in total knee replacement procedures.
PERRIGO COMPANY PLC: Announces FDA Final Approval For AB Rated Generic Version Of Voltaren® Gel 1%
Perrigo Company plc (NYSE; TASE: PRGO) announced its partner received final approval from the U.S. Food and Drug Administration for its AB rated Abbreviated New Drug Application (ANDA) referencing Voltaren® Gel, 1% (diclofenac sodium topical gel, 1%).
ZEBRA MEDICAL VISION: Zebra Medical Vision Receives FDA Approval for World's First AI Chest X-ray Triage Product
Zebra Medical Vision (https://www.zebra-med.com/), the deep learning imaging analytics company, announces that it has received FDA 510(k) clearance for HealthPNX - an AI alert for pneumothorax (PNX), based on chest X-rays.