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The latest update is out from EBR Systems, Inc. Shs Chess Depository Interests Repr 1 Sh ( (AU:EBR) ).
EBR Systems, Inc. announced that the Centers for Medicare & Medicaid Services (CMS) has accepted its WiSE System into the Transitional Coverage for Emerging Technologies (TCET) reimbursement pathway, a program designed for FDA-designated Breakthrough Devices. This acceptance is significant as it allows for expedited Medicare coverage, providing patients early access to innovative medical technologies. The U.S. Food and Drug Administration has also completed a manufacturing Pre-Approval Inspection of EBR’s facilities without any observations, marking a positive step forward for the company’s operations and market positioning.
More about EBR Systems, Inc. Shs Chess Depository Interests Repr 1 Sh
Silicon Valley-based EBR Systems, Inc. is dedicated to advancing the treatment of cardiac rhythm disorders through its innovative Wireless Stimulation Endocardially (WiSE) technology. This technology provides wireless cardiac pacing, specifically designed to eliminate the need for cardiac pacing leads, thereby addressing complications and reliability issues. The initial product targets heart failure patients requiring Cardiac Resynchronisation Therapy, with future applications potentially extending to bradycardia and other non-cardiac conditions.
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