Thursday, April 18, 2024

Thursday, April 18, 2024

Reform

Reform

AVITA MEDICAL: Receives U.S. FDA Investigational Device Exemption Approval of Clinical Feasibility Study to Evaluate RECELL System for Vitiligo

By Press release submission | Jan 6, 2020

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IOTAMOTION: Submits De Novo Application To FDA For iotaSOFT™ Cochlear Implant Insertion System

By Press release submission | Jan 3, 2020

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CRYOLIFE: Receives FDA Authorization to Commence PROACT Xa Clinical Trial

By Press release submission | Jan 2, 2020

Latest News

SOLITON: Announces Successful Completion of Safety Testing at SGS to Support FDA Filing for Second Generation Device

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By Press release submission | Dec 30, 2019

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

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By Press release submission | Dec 30, 2019

Interscope, Inc. announced today the receipt of marketing clearance from the FDA for the EndoRotor® System to commercialize Pulmonary indications.

FORWARD SCIENCE: Receives FDA Clearance for Orapeutic for Opioid Free Oral Pain Management

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By Press release submission | Dec 19, 2019

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

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By Press release submission | Dec 19, 2019

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

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By Press release submission | Dec 2, 2019

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.: Announces FDA Breakthrough Device Designation for endoscopic AI system

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By Press release submission | Nov 11, 2019

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.

COMPUGEN: Announces FDA Clearance of IND Application for COM902

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By Press release submission | Nov 5, 2019

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

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By Press release submission | Nov 1, 2019

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

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By Press release submission | Oct 31, 2019

Over 60 New Tests of the Recalled Lot Conducted by Two Third-Party Laboratories Find No Asbestos

FDA reports progress in support of opioid recovery and treatment act

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By Bree Gonzales | Oct 30, 2019

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

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By Press release submission | Oct 28, 2019

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

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By Press release submission | Oct 25, 2019

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

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By Press release submission | Oct 23, 2019

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

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By Press release submission | Oct 22, 2019

Application Seeks to Extend Duration of Use Up to Six Years for Mirena

ORTHO CLINICAL DIAGNOSTICS: FDA Clears ORTHO™ Sera ID-MTS for Use on the ORTHO VISION® Analyzer

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By Press release submission | Oct 18, 2019

Fully Automated Technology from Ortho Clinical Diagnostics Aids in Extended Antigen Phenotyping and Ensures Delivery of Safe Blood to Transfusion Patients

Former FDA official responds – in part – to Taxpayers Protection Alliance's suggested reforms

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By Colin Froment | Oct 18, 2019

Dr. David Gortler, former Food and Drug Administration (FDA) official, drug safety and FDA regulatory affairs expert and pharmacology professor, responds to the Taxpayers Protection Alliances’ (TPA) list of recommendations to improve business strategies released Oct. 3.

CARBOFIX: Extends Its CarboClear® Carbon Fiber Spinal Product Line With Its FDA Cleared Vertebral Body Replacement (VBR) System

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By Press release submission | Oct 17, 2019

The product to be officially launched during the Congress of Neurological Surgeons (CNS) in San Francisco, October 21-23, 2019

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