iotaMotion has filed a De Novo application with the FDA for authorization to market its iotaSOFT™ cochlear implant insertion system in the US.
Study Designed to Evaluate the Use of Apixaban in On-X Aortic Valve Patients
SOLITON: Announces Successful Completion of Safety Testing at SGS to Support FDA Filing for Second Generation 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 its Rapid Acoustic Pulse ("RAP") device successfully completed the IEC 60601 safety testing being conducted at SGS, the world's leading inspection, verification, testing and certification company. The testing was led by a team at Sanmina Corporation, a leading electronics manufacturing services provider.
INTERSCOPE: Announces new FDA Clearance of the EndoRotor®, for use in Airway procedures including in Interventional Pulmonology
Interscope, Inc. announced today the receipt of marketing clearance from the FDA for the EndoRotor® System to commercialize Pulmonary indications.
Forward Science received FDA Clearance for OrapeuticTM, a non-opioid oral pain relief gel. Forward Science is a MedTech company that operates R&D, its quality system, manufacturing, sales and support all from its Worldwide headquarters in Houston, TX.
UROGEN PHARMA: Announces FDA Filing Acceptance and Priority Review of U.S. New Drug Application (NDA) for UGN-101
Potential for UGN 101 to be First Non-Surgical Therapy for the Treatment of Low-Grade Upper Tract Urothelial Cancer (LG UTUC)
SECTRA: Sectra and Leica Biosystems Partner to Pursue FDA Clearance for an Integrated Clinical Digital Pathology Solution
International medical imaging IT and cybersecurity company Sectra (STO: SECT B) and Leica Biosystems announce collaboration for an integrated clinical pathology solution.
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.
Phase 1 clinical study in patients with advanced malignancies expected to begin in early 2020
U.S. FDA: Digital submission of adverse event reports for investigational new drug applications reflects FDA's ongoing modernization efforts
The U.S. Food and Drug Administration is taking steps towards requiring electronic submission of certain safety reports for products being evaluated by the FDA under an investigational new drug (IND) application into the FDA's Adverse Event Reporting System (FAERS).
JOHNSON & JOHNSON CONSUMER INC.: 15 New Tests from the Same Bottle of Johnson's Baby Powder Previously Tested by FDA Find No Asbestos
Over 60 New Tests of the Recalled Lot Conducted by Two Third-Party Laboratories Find No Asbestos
The U.S. Food and Drug Administration's (FDA) acting commissioner, Dr. Ned Sharpless, has released a statement on the agency’s efforts to address the opioid crisis as the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act marked its one year anniversary on Oct. 24.
CARSGEN: Announces Investigational CAR-T Therapy CT053 Granted RMAT Designation by the U.S. FDA for R/R Multiple Myeloma
ARsgen Therapeutics Co. Ltd., a clinical-stage biopharmaceutical company today announced that the United States Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational CT053 CAR-T cell therapy. CT053 is a fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cell therapy for the treatment of relapsed and/or refractory multiple myeloma (rrMM).
FRESENIUS MEDICAL CARE: Receives FDA Breakthrough Device Designation for New Dialysis System to Prevent Blood Clotting Without the Use of Blood Thinners
Surface Modifying Macromolecules in Dialyzers and Bloodlines are Paired with Dialysate Formula to Prevent Clots
GARWOOD MEDICAL DEVICES: FDA Grants Breakthrough Device Designation to BioPrax™ Biofilm Disruption Device
Garwood Medical Devices, a company focused on advancing infection control through innovation, announces today that it has been granted Breakthrough Device designation by the Food and Drug Administration (FDA) for its BioPrax™ device.
BAYER: Submits Supplemental New Drug Application to FDA for Intrauterine Device (IUD) Mirena® (levonorgestrel-releasing intrauterine system) 52 mg
Application Seeks to Extend Duration of Use Up to Six Years for Mirena
Fully Automated Technology from Ortho Clinical Diagnostics Aids in Extended Antigen Phenotyping and Ensures Delivery of Safe Blood to Transfusion Patients