CMS Proposes Extra Payments On CustomFlex Iris, Single-Use Duodenoscope, Heart Device
Medicare agency discusses unique nature of devices in outpatient payment system proposed rule
The Centers for Medicare and Medicaid Services highlighted three FDA breakthrough devices it is proposing for additional pass-through payments in its 2021 outpatient pay rule.
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Researchers have created the "smart contact lens" to dynamically improve the vision of people with various optical defects.
Amid concerns of infections from duodenoscopes that are not sufficiently re-sterilized, the US FDA has cleared Boston Scientific’s Exalt-D as a the first single-use duodenoscope. Investors expect the device will likely take a significant chunk of the market, especially considering the next competitor is at least a year away.
The PMA approval is based on the results of the BeAT HF trial, which showed that baroflex activation therapy with Barostim Neo safely improves quality-of-life scores and exercise capacity in patients with heart failure and reduced ejection fraction.