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.”
The U.S. Food and Drug Administration continues to play a critical role in accelerating medical countermeasures to treat and prevent COVID-19. As part of the response to this pandemic, the agency is taking the lead on a national effort to facilitate the development of, and access to, two investigational therapies derived from human blood.
The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for a new diagnostic test that will enable hospitals to screen for COVID-19 (coronavirus) on site and get results in under three hours.
As part of the FDA's ongoing commitment to fight the Coronavirus Disease 2019 pandemic, today the agency issued guidance for immediate implementation to address the urgent and immediate need for blood and blood components.
The Food and Drug Administration cleared the Tablo Hemodialysis System for patient use in the home. The new home clearance expands Tablo's existing labeled indication for use in acute and chronic care facilities, which for the first time enables healthcare providers the same dialysis machine from the ICU to the home.
The clearance applies for Sectra Digital Pathology Module, the key component of Sectra's pathology solution, when used together with Leica Biosystems' scanner AT2 DX. This enables US healthcare providers to use Sectra's digital pathology solution for primary diagnostics. The solution makes it possible to move towards fully integrated diagnostics, which is especially important in complex cancer cases.
As part of the Trump Administration's all-hands-on-deck approach across public, academic, and private sectors to combat the COVID-19 pandemic, the FDA stood up a new program to expedite the development of potentially safe and effective life-saving treatments.
The novel single-use micro-endoscope with multiple working channels eliminates the risk of transmitting infections between patients notes enlightenVue.
