Bill Would Require Medicare to Cover New Breakthrough Devices for at Least 4 Years
The bill is designed to provide Medicare patients faster access to innovative technology approved by the FDA.
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New Breakthrough Device Designations Fall 37 Percent in 2022
According to the FDA’s recently-released annual report, only 135 devices received the designation last year, versus 213 in 2021.
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Want Breakthrough Device Designation? You’ll Need to Consider Health Equity
In draft guidance, the FDA is proposing that medical device makers will need to consider how accessible their products are to underserved populations.
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FDA to Consider Health Disparities in Granting Breakthrough Device Designation
Medical device makers will have to show that their products will be accessible to disadvantaged populations.
FDA Launches Pilot Program to “De-risk the Medical Device Valley of Death”
The CDRH Total Product Life Cycle Advisory Program Pilot aims to improve the FDA authorization process for medical devices.