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Updated: 3 hours 55 min ago

FDA Plans to Streamline Third-Party 510(k) Reviews

Thu, 2018-09-13 23:00
The FDA has announced a framework to streamline third-party reviews of certain lower-risk medical devices.

FDA Issues Draft Guidance on Considering Uncertainty in Device Submissions

Wed, 2018-09-05 23:00
The Food and Drug Administration (FDA) has issued draft guidance intended to update how the agency approaches acceptable levels of uncertainty when determining the benefits and risks of medical devices during certain premarket submissions.

Facebook, NYU School of Medicine Collaborate to Improve MRIs

Mon, 2018-08-27 23:00
In an effort to improve healthcare technology, two very different organizations are teaming up—social media giant Facebook and the New York University (NYU) School of Medicine’s Department of Radiology. The two institutions have announced a collaborative research project to improve the speed of magnetic resonance imaging (MRI) scanning through the use of artificial intelligence (AI).

FDA Examines Barriers to Pediatric Technology Development

Mon, 2018-08-20 23:00
In many instances, the medical devices available in the pediatric field lag behind their adult counterparts or don’t exist at all, forcing clinicians to use adult devices off-label for children or rely on older technology. To address the issues forestalling pediatric medical device development, the Food and Drug Administration (FDA) convened a public meeting and workshop last month, delving into the financial, regulatory, and design constraints.

FDA Explains Process for Denial of Certificate to Foreign Government for Devices

Sun, 2018-08-19 23:00
The Food and Drug Administration (FDA) is accepting comments until Oct. 16 on draft guidance explaining why the agency may deny issuing a Certificate to Foreign Government (CFG) to medical device manufacturers.

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