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EYEYON MEDICAL: Breakthrough Device Designation Received From the FDA for EndoArt®
February 9, 2020
EyeYon medical Ltd. announces Breakthrough Status Designation from the U.S. Food and Drug Administration (FDA) for its EndoArt®, Artificial Endothelial Layer Implant.
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CARDIOFOCUS: Announces U.S. FDA PMA Supplement Submission For The Breakthrough HeartLight X3 Endoscopic Ablation System
February 4, 2020
CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), today announced that the company has submitted a pre-market approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) for the HeartLight X3 Endoscopic Ablation System for the treatment of AFib.
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MOST SACRED HEART OF JESUS CARDIOLOGY AND VALVULAR INSTITUTE: Dr. Rajamannan Sends Over to the FDA Commissioner the US Senate Finance Investigation Files to Help the FDA’s Review of Newly Discovered Design Control Study in Chicago
January 27, 2020
Minneapolis FDA delays reporting to the patients in Chicago the non-exempt testing of the device affecting 667 patients
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MOST SACRED HEART OF JESUS CARDIOLOGY: Newly Minted FDA Commissioner Dr. Stephen Hahn Receives Minneapolis FDA Affidavit From Dr. Nalini Rajamannan Regarding FDA Design Control Study Using a Non-Exempt Medical Device
January 22, 2020
Minneapolis FDA confirms no plan to inform patients of non-exempt medical devices placed in 667 citizens
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UROGEN PHARMA: Announces FDA Filing Acceptance and Priority Review of U.S. New Drug Application (NDA) for UGN-101
December 19, 2019
Potential for UGN 101 to be First Non-Surgical Therapy for the Treatment of Low-Grade Upper Tract Urothelial Cancer (LG UTUC)
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3DBIO THERAPEUTICS: Receives FDA Rare Pediatric Disease Designation for AuriNovo™ for Ear Reconstruction in Microtia Patients
December 8, 2019
3DBio Therapeutics, an emerging leader in the field of 3D-bioprinting for human therapeutic use, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation for AuriNovo™, an investigational combination product for reconstruction of the outer ear in patients with microtia.
Read more →MolecuLight Receives FDA 510(k) Clearance for its i:X® Handheld Fluorescence Imaging Device for Wound Management
December 6, 2019
New FDA Approval Extends Label to Including the i:X's Detection of Bacteria and Digital Wound Measurement
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IRRAS: Announces FDA Clearance of New 510(K) Filing to Expand the Time of Use of IRRAflow®
November 25, 2019
IRRAS, a global healthcare company with a comprehensive portfolio of innovative products for neurocritical care, announced today that the US FDA has cleared a new 510(K) for IRRAflow.
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AI MEDICAL SERVICE INC.: Announces FDA Breakthrough Device Designation for endoscopic AI system
November 12, 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.
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