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EMURMUR: FDA grants clearance for a heart murmur detection solution on a personal mobile device
eMurmur ID is an artificial intelligence-based solution that enables healthcare providers to detect and classify heart murmurs with expert-level accuracy
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TRACELINK, INC.: FDA Approves TraceLink DSCSA Pilot Submission for Network Solutions; Delivering 2023 Traceability By Leveraging Blockchain and Digital Recalls Across a Supply Network
TraceLink Inc., the world's largest integrated digital supply network providing real-time information sharing for better patient outcomes, announced the acceptance of its participation in the Food and Drug Administration (FDA) Pilot Project Program under the Drug Supply Chain Security Act (DSCSA).
CCHF president speaks out on FDA drug approval process
Citizensʼ Council for Health Freedom Media president Twila Brase says the current FDA drug approval process is too long and expensive.
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.
Measles cases in U.S. hit 839 so far this year, CDC reports
The number of U.S. measles cases confirmed this year reached 839 as of May 10, the highest level for any year since the nation declared the disease eliminated in 2000, according to the Centers for Disease Control and Prevention.
SOLITON INC.: Provides FDA Update and Addresses Recent Anonymous Article
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"), provided an update on its application for FDA clearance and addressed a recent anonymous article published on SeekingAlpha.com.
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%).
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MEDICAL MARIJUANA, INC.: CEO Chosen to Present Oral Comments at FDA's Public Hearing on Products Containing Cannabis and Cannabis-Derived Compounds
Medical Marijuana, Inc. (OTC: MJNA), the first publicly traded cannabis company in the United States, announced today that the Company's CEO, Dr. Stuart Titus, has been chosen as one of 65 speakers to present oral comments at the U.S. Food & Drug Administration (FDA)'s upcoming public hearing discussing scientific data and information about products containing cannabis-derived compounds.
U.S. FOOD AND DRUG ADMINISTRATION: Federal court enters consent decree against Texas compounder, Pharm D Solutions, LLC to cease the manufacturing of drugs intended to be sterile due to insanitary conditions
U.S. District Judge Keith P. Ellison for the Southern District of Texas signed and entered a consent decree of permanent injunction, ordering a Texas-based company and its owners to stop producing compounded drugs intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements.
U.S. FOOD AND DRUG ADMINISTRATION: Federal judge enters consent decree against compounder PharMedium Services for violations at multiple facilities
U.S. District Judge Virginia M. Kendall for the Northern District of Illinois entered a consent decree of permanent injunction between the United States and PharMedium Services, LLC, headquartered in Lake Forest, Ill., as well as Scott Aladeen, the company’s president, and Warren Horton, vice president for Quality and Research and Development.
Former commissioners promote idea of an independent FDA
This week, Eli Adashi, Rohit Rajan, and Glenn Cohen will have another paper published in Science that says the FDA is being undermined because of politically motivated congressional legislators, especially recently.
Health policy expert rejects suggestion of FDA independence
Two papers written by seven former FDA commissioners suggest the organization should become an independent agency.
Arizona doctor disagrees with FDA papers that claim agency should be indepedent
Seven former Food and Drug Administration commissioners suggested in a couple of articles that the FDA should become an independent agency
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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.
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
FDA warns of unapproved diabetes devices
In a safety communication released last week, the Food and Drug Administration warned against unapproved and unauthorized devices for diabetes.
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
OCTAPHARMA USA: FDA Approves New Octaplas™ Product Label
New Labeling Reports Results of Post-Marketing Study Demonstrating Safety, Efficacy and Tolerability in Pediatric Patients
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.
Cook, Los Angeles, Miami-Dade counties most at risk of measles outbreak, study finds
Illinois’ Cook County is the U.S. jurisdiction most at risk of a measles outbreak this year, according to a study published this month in the British medical journal The Lancet Infectious Diseases.