News Briefs: Updates From Around The Industry
This article was originally published in The Gray Sheet
FDA's Circulatory Systems Devices Panel will look at leadless pacemaker evidence needs; neurostim news from Nevro and Medtronic; BD and CareFusion hold hands; a Google-launched health tech firm gets a name; and more product and business updates.
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The company says the Senza high-frequency system is the first spinal cord stimulator to be approved to claim superiority over existing spinal cord stimulation therapies. Approval is based on results of the highly touted SENZA-RCT trial.
The firm’s bare-bones booth at the North American Spine Society annual meeting was a conspicuous sign of strains between Medtronic and the clinical group over how issues surrounding its rhBMP-2 Infuse bone graft have been presented.
New rules in India specify that a marketer of a drug will share the onus for quality and compliance along with the manufacturer. Enhanced punishment for misleading advertisements for a range of illnesses is also proposed, while calls for a statute to regulate pharma's marketing practices grow louder.