The authorization is a step toward broad screening that will help reopen schools and workplaces in America, says FDA Commissioner Stephen Hahn, M.D.
With everything to gain, telehealth may lead to a new standard in health/wellness treatment while at the same time unifying the entire healthcare ecosystem.
Companies developing technologies that integrate AI need to consider regulatory concerns, community demographics, fitting into existing workflows, technical proficiency of both the hospital personnel and consumers.
When a device is implanted in a human body, there is always a distinct reaction of the body’s immune system, often resulting in a thick layer of scar tissue surrounding the implant. With device miniaturization and by providing a ‘biomimetic’ device encapsulation, this body reaction will be reduced.
Operating with an antiquated QMS raises your risk. Here’s what to consider when modernizing your system.
The medical device industry is pressured to aid those stricken by the pandemic, while at the same time working to mitigate increased risks usually associated with hurried manufacturing and quality control procedures.
The winning innovators will receive grant awards of upwards of $50,000.
User needs and expectations continue to advance. Medical device technology needs to keep pace. For a successful design, take the following requirements into consideration.
Investments in new processes and systems must satisfy the needs of the authorities and ensure patient safety and public confidence. Getting it right is likely to be expensive. but regulatory compliance shouldn’t be viewed purely as a cost center.
While companies developing solutions that address the current pandemic may be receiving an influx of financial support, recovery for companies in other segments of the industry is slow.
