MedTech leaders face rising pressures from health care providers and growing competition, in addition to stringent regulations. Discover how adopting digital technologies can help in this upcoming webinar.
The final rule, issued without notice or comment, brings the software classifications in line with provisions of the 21st Century Cures Act and reflects the agency's current statutory authority.
The Medicare agency postponed the proposal from taking effect amid criticism from some doctors and safety groups that it risks promoting device use without rigorous evidence of safety and effectiveness.
CEO Robert Ford told investors on Tuesday that $1.8 billion in sales were from its rapid coronavirus testing platforms as he sees a shift to surveillance. But he acknowledged testing is "difficult to forecast right now."
The agency said that the latest is not related to an August 2020 recall, although the malfunctions are similar to past issues. However, no serious injuries or deaths have been connected to the most recent action.
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