The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has proposed that devices that aim to eliminate disparities in health care be designated breakthrough ...
The US Food and Drug Administration (FDA) has already accepted its first product under its new "Breakthrough" therapies designation, and more are soon to be on the way, a high-ranking agency official ...
A new bipartisan bill, the Ensuring Patient Access to Critical Breakthrough Products Act, has been introduced by lawmakers looking to require Medicare to cover new breakthrough medical devices for ...
A new bill aims to require Medicare cover new breakthrough medical devices for four years as the agency prepares for its own regulation on the issue. A bipartisan group of House lawmakers introduced ...
Obtaining Medicare coverage and reimbursement for medical devices is notoriously more difficult than for drugs or biologics, and any progress on expanding coverage pathways has been agonizingly slow ...
Apple has a long history of designing products that aren’t the first to be introduced in a particular category but still redefine the market. With the company unveiling a headset equipped with virtual ...
The Bion microstimulator is a miniature, self-contained, rechargeable implantable neurostimulator manufactured by Advanced Bionics Corp. (Valencia, CA). The Hand Mentor rehabilitation system, ...
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