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South Korea has updated its medical device regulations to provide a pathway for innovative technologies such as artificial intelligence, robotics and 3D printing technology applied to medical devices. Read More
The agency noted that it is seeking feedback on all elements of the guidance, including the benefits and risks of smooth and textured breast implants. Read More
Devicemakers should assess cybersecurity risks throughout the product lifecycle, the International Medical Device Regulators Forum (IMDRF) says, in a new draft guidance that calls for “convergence of global healthcare cybersecurity principles and practices.” Read More
The FDA is introducing a new review program for certain medical devices and device-led combination products that are expected to significantly improve the safety of treatments for a disease or condition deemed less serious than those eligible for the breakthrough devices program. Read More
The FDA issued a warning letter to Polymer Technology Systems — doing business as PTS Diagnostics — arising from an inspection earlier this year of its facility in Indianapolis. Read More