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Latest From Ferdous Al-Faruque
The agency slowed down its effort to require the overwhelming majority of medical devices to adopt Unique Device Identifiers with a a new guidance that would in delay full implementation of the UDI system for lower-risk devices.
Starting out 2018, Scott Gottlieb issued a new directive to US FDA staff outlining his priorities and vision. Among the directives is to promote digital health and diagnostics by creating efficient pathways for new products in the areas and focusing on technology to help consumers better track their health.
In a sign of the times, the Medical Imaging & Technology Alliance, a major medtech trade organization in Washington, DC, has established a new director position on cybersecurity and has hired someone to fill it. Zack Hornberger will lead MITA's efforts to develop positions on cybersecurity policy and standards.
The past year saw US FDA and industry work hard and fast to prepare for what looks like an inevitable boom in the digital-health sector. According to interviews, the time is ripe for adoption of mobile health apps to help reduce health-care costs, but the brave new world also brings with it big challenges.
Liam Kelly has been promoted to CEO of Teleflex, moving up from his chief operating officer post. He replaced Benson Smith in the top spot.
Intragastric balloon-maker Allurion is making some major changes in its executive suite to support its plan to expand its market reach.