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Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.
Aurion Biotech Receives Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation for Its Drug Candidate AURN001
Sterling Chung, Vice President of Regulatory Affairs and Quality at Aurion Biotech. “These designations underscore the importance of developing a potential solution for millions of patients around the world who suffer from corneal endothelial diseases. We look forward to working closely with the FDA to expedite the development of our cell therapy.”
Neuromod’s FDA-Approved Lenire Device Now a Treatment Option for 2.9 Million US Veterans with Tinnitus
The Lenire Device is the first bimodal neuromodulation device to receive a Federal Supply Schedule (FSS) Contract. It can be prescribed when appropriate by a trained healthcare clinician for the treatment of tinnitus.
Justice Department and FDA Announce Federal Multi-Agency Task Force to Curb the Distribution and Sale of Illegal E-Cigarettes
"Unauthorized e-cigarettes and vaping products continue to jeopardize the health of Americans – particularly children and adolescents – across the country," said Acting Associate Attorney General Benjamin C. Mizer. "This interagency Task Force is dedicated to protecting Americans by combatting the unlawful sale and distribution of these products. And the establishment of this Task Force makes clear that vigorous enforcement of the tobacco laws is a government-wide priority."
Tris Pharma Receives U.S. FDA Approval for Once-Daily ONYDA XR (clonidine hydrochloride) Extended-Release Oral Suspension, the First-and-Only Liquid Non-Stimulant ADHD Medication
ONYDA XR is indicated for the treatment of ADHD as monotherapy or as adjunctive therapy to approved CNS stimulant medications in pediatric patients six years and older. The first non-stimulant ADHD medication, with nighttime dosing, adds to Tris Pharma’s established portfolio of leading ADHD therapies and reinforces company's commitment to individuals with ADHD.
Indica Labs Receives FDA Clearance for HALO AP Dx Digital Pathology Platform for Use with Hamamatsu Images Acquired with the NanoZoomer® S360MD Slide Scanner
Indica Labs, an industry leader in AI-powered digital pathology solutions, and Hamamatsu Photonics K.K., a pioneer in whole slide imaging systems, announce that the...
FDA Grants AI-Powered Notal Vision Home OCT “SCANLY” De Novo Marketing Authorization
“We are very excited to receive FDA authorization to market SCANLY Home OCT as the first-ever patient self-operated, home-use device that gives physicians remote access to high-resolution, cross-sectional retinal images and AI-based analytical biomarkers of their patients eyes between office visits,” said Kester Nahen, PhD, CEO of Notal Vision. “We look forward to supporting our referring physicians in navigating their wet AMD patients’ care.”
Atraverse Medical Receives FDA Clearance for HOTWIRE™ Left Heart Access Device, Oversubscribes Seed Round with $12.5M Invested
The HOTWIRE system, invented by Atraverse Medical Co-Founders Dr. Steven Mickelsen and Eric Sauter, introduces a paradigm shift in left-heart access.
RapidAI Secures FDA Clearance for Perfusion Imaging in the Angiography Suite
“We are pleased to expand our stroke AI imaging portfolio, the broadest in the industry, to include this new module. With AngioFlow™ by RapidAI, we can now support stroke AI imaging along the entire patient pathway, from the initial non-contrast CT scan all the way to the interventional suite,” said Karim Karti, CEO of RapidAI. “Already registered and used in Japan and Europe, we believe this technology will make a significant difference in the lives of U.S. stroke patients.”
Intuity Medical’s POGO Automatic ®, the First and Only FDA-Cleared Automatic Blood Glucose Monitor, Now Covered by Medicare Part B
Recognized by healthcare professionals for its user-friendly design which can improve testing compliance, POGO Automatic is endorsed as the ideal solution for many diabetes patients by Rosemarie Lajara, MD, an endocrinologist with Southern Endocrinology & Diabetes Associates, P.A. in Plano, Texas