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.
“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.”
“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.”
Randy Nagy, founder of Gentueri commented, "Obtaining FDA Registration of our new larger facility represents an important step in our expansion plans as we significantly increase capacity and meet the requirements of new medical device markets.
VX1 is a machine and deep learning-based algorithm designed to assist operators in the real-time manual annotation of 3D anatomical and electrical maps of the human atria during atrial fibrillation (AFib) or atrial tachycardia.
Hologic notes the new technology which the company has now made commercially available represents a pivotal milestone in the early detection of breast cancer, as studies showed Genius AI Detection software aids in the identification and early detection of breast cancer when used with the Genius 3D Mammography exam.
"FDA approval of the INTERCEPT Blood System for Cryoprecipitation is an important step forward in our mission to establish pathogen reduction as the standard of care for transfused blood components globally," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer.
FDA Principal Deputy Commissioner Amy Abernethy M.D., Ph.D. "Developing a treatment for a rare disease can be complex. Collaboration, including through the use of technology, is critical to supporting and facilitating efficient processes for these types of necessary treatments.
"The ongoing evolution of the TSolution One Total Knee Application is a testament to THINK Surgical's dedication and investment in advancing the use of robot technology in the orthopedic setting," said Jay Yang, acting CEO, THINK Surgical.
Indigo Aspiration System, Lightning 12 (Indigo System CAT™ 12 Aspiration Catheter with Lightning Intelligent Aspiration), and Separator 12 are now indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems as well as for the treatment of pulmonary embolism.
