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BioWorld - Tuesday, July 21, 2026
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MDD's Oncology Extra

Feb. 10, 2016

CMS drops mandate for controls in registry studies in final LAA decision memo

Feb. 10, 2016
By Mark McCarty
The CMS has rendered a final coverage decision for left atrial appendage devices, a move driven largely by the successful Watchman PMA by Boston Scientific, which slogged through three FDA advisory committee hearings on its way to the CMS coverage analysis. The final decision memo included several important changes compared to the draft, including that the agency has dropped the demand for a contemporaneous set of patients on medical therapy, making the resulting study a simpler and less expensive one-arm registry study.
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Senate HELP committee votes in favor of a host of new health care bills

Feb. 10, 2016
By Richie Crider

Mederi struts its Stretta system as 'middle therapy' for GERD

Feb. 10, 2016
By Amanda Pedersen

Cancer research draws dollars in proposed NIH, FDA budgets, plus funds for Zika virus

Feb. 10, 2016
By Michael Fitzhugh

Bellerophon drug-device wins big in phase II data; SPA covers ongoing effort

Feb. 10, 2016
By Randy Osborne

EMA guides Alzheimer's trial design with use of new diagnostics criteria

Feb. 10, 2016
By Nuala Moran

Other news to note

Feb. 10, 2016

Appointments and advancements

Feb. 10, 2016

Product briefs

Feb. 10, 2016
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