Spotlight On... Novocure submits second-gen brain cancer treatment device for FDA approval; Torax gets humanitarian FDA nod for fecal incontinence; Insulet partners with Glooko; and more...

The Optune system--Courtesy of Novocure

St. Helier, NJ's Novocure ($NVCR) submitted a PMA supplement with the FDA, in hopes of marketing an upgraded version of its noninvasive Optune system to treat glioblastoma, a type of brain tumor. PMA supplements enable modifications to PMA-approved devices. The second generation Optune system weighs 2.7 pounds, compared to 6 pounds for the current version. "The big improvement with the second generation device is the reduction in size and weight achieved by digital signal generation technology. From a patient-convenience view, we believe it is a significant step forward," said Novocure COO Mike Ambrogi, in a statement. The second-generation of the Optune is already available in Europe. Release

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