Pressure mounts on politicians, FDA to react to vaping-related illnesses, deaths
According to an article on the Forbes website, vaping will impact two sectors of the financial markets the most: Big Tobacco and marijuana stocks.
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FDA unveils guidances for digital health care
The U.S. Food and Drug Administration (FDA) recently unveiled a series of guidances about utilizing digital health tools to help patients.
LASER ASSOCIATED SCIENCES: Blood Flow Monitoring Device - FlowMet-R Gets FDA 510K Clearance
Laser Associated Sciences' Non-Invasive Device Disrupting the Industry
Q BIOMED: Announces Legal Settlement and Acquisition of FDA Approved Non-Opioid Metastatic Cancer Pain Drug
Company Settles Legal Action Resulting in Outright Ownership of the Drug
PROTOM: Receives U.S. FDA 510(k) Clearance for Its Radiance 330® Single Room Proton Therapy System
ProTom International Holding Corporation ("ProTom"), a market-leading proton therapy technology manufacturer, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for its Radiance 330 proton therapy system installed at Massachusetts General Hospital ("MGH") in Boston, Massachusetts.
TRINEtX: Named Technology Partner for FDA Sentinel System
TriNetX, the global health research network that revolutionizes clinical research and enables discoveries through the generation of real-world evidence (RWE), has been named a technology partner in two coordinating centers of the FDA's Sentinel System, a national program that uses electronic health care data to monitor the safety of FDA-regulated drugs and other medical products.
TECLENS: TECLens and SERVImed Industrial Spa Announce a Partnership to Pursue U.S. FDA Approval for Trans-epithelial Corneal Cross-Linking
TECLens, a medical device manufacturer and SERVImed Industrial Spa, an ophthalmic medical devices manufacturer and distributor today announced their partnership aimed at development and FDA approval of a new combination product to treat keratoconus.
SEKISUI DIAGNOSTICS: Announces FDA Clearance and CLIA Waiver of the Acucy™ Influenza A&B Test
Sekisui Diagnostics announces the Acucy Influenza A&B Test has received 510(k) clearance as a Class II assay from the US Food and Drug Administration (FDA), as well as, CLIA Waiver (Clinical Laboratory Improvement Amendments) for use on the Acucy Reader.
INTARCIA THERAPEUTICS: Provides Regulatory Update - FDA Accepts Resubmitted New Drug Application For ITCA 650
Intarcia Therapeutics, Inc., announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's resubmission of its new drug application (NDA) for ITCA 650 (exenatide implant), for the treatment of type 2 diabetes mellitus. Intarcia resubmitted the NDA on September 9th, 2019 and the FDA has recently communicated that it considers the NDA resubmission a complete class 2 response, setting the Prescription Drug User Fee Act (PDUFA) target action date of March 9, 2020.
FDA awards more than $4.1 million for natural history studies of rare diseases
The U.S. Food and Drug Administration (FDA) is providing more than $4.1 million in the next four years to fund two natural history studies of rare diseases.
FDA awards $15 million grant to 12 new clinical trials for rare-disease treatments
Over the next four years, the U.S. Food and Drug Administration (FDA) will be providing more than $15 million to 12 new clinical trials. The grants will help enhance the development of medical products for patients with rare diseases – mainly those affecting children.
BIPRI, LLC: Solving Migraines With Unique FDA-Registered Vibration Massage Therapy Device
The BIPRI 8-Motor Headband Is Changing the Game for Chronic Migraine Sufferers.
ABSORPTION SYSTEMS: Awarded 5-year IDIQ Contract by the U.S. Food and Drug Administration
To conduct preclinical testing of locally-acting topical dermal and ophthalmic drug product formulations
Taxpayers Protection Alliance recommends FDA reforms
The U.S. Food and Drug Administration (FDA) holds primary responsibility for approving and regulating various human and animal prescription drugs, medical and tobacco products and the nation’s food supply.
BECKMAN COULTER: DxA 5000 total laboratory automation solution receives U.S. FDA 510(k) clearance
Beckman Coulter, a global leader in clinical diagnostics, announced that the DxA 5000 total laboratory automation solution has received FDA 510(k) clearance and is now available for sale in the United States.
ALLSCRIPTS: Veradigm Health joins Harvard Pilgrim to develop next phase of FDA’s Sentinel System
Five-year award signals FDA’s commitment to national program utilizing electronic healthcare data to monitor the safety of FDA-regulated drugs and other medical products
FDA Update: recent animal drug approvals
Federal law dictates that drug companies can’t manufacture and market medicines for animals unless they get the approval of the U.S. Food and Drug Administration.
THINK SURGICAL: Receives FDA Clearance to Market Active Robot for Total Knee Replacement Procedures in the United States
Approval follows multi-center investigational clinical trial evaluating safety and efficacy of TSolution One® Total Knee Application
WONTECH: Receives FDA Clearance for 'HairBoom Air'
WONTECH (Reno Kim, CEO of WONTECH, www.wtlaser.com) a leading Korean laser and energy based medical aesthetic device company announced that its LLLT hair loss treatment device, HairBoom Air, received U.S. Food and Drug Administration 510(K) clearance.
OSSDSIGN AB: Receives US FDA Clearance for Cranial PSI Accessories - Strengthening Business Position in the US
OssDsign AB (publ) ("OssDsign" or the "Company") today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance (K190523) to market OssDsign Cranial PSI Accessories in the US.