WASHINGTON – Scott Gottlieb has been out of the U.S. FDA commissioner's seat for just over one month. Now, he is providing a few of his thoughts on reimbursement and the potential for Medicare for All, which he says has a "seductive political appeal for its seeming simplicity." This simplicity has prompted him to believe that "the prospects for single-payer Medicare are probably nearer to happen than I think many fully appreciate right now as a political matter." He made these comments during a presentation at the National Press Club in Washington, D.C., Friday.

WASHINGTON – Scott Gottlieb has been out of the U.S. FDA commissioner's seat for just over one month. Now, he is providing a few of his thoughts on reimbursement and the potential for Medicare for All, which he says has a "seductive political appeal for its seeming simplicity."

Boston Scientific Corp., of Marlborough, Mass., has inked an agreement to buy Carlsbad, Calif.-based Vertiflex Inc., which has developed and commercialized the Superion indirect decompression system. The deal includes $465 million in up-front cash and additional payments based on commercial milestones for the next three years.

Yokneam, Israel-based Rapid Medical has won the FDA's nod for its Comaneci device temporary coil embolization assist device. The company said that Comaneci is the first in a new category of temporary coil embolization assist devices. The Comaneci is an adjustable, fully visible aneurysm remodeling device, which acts as a temporary bridge used to aid in the coiling processes while minimizing the risk of coil protrusion or prolapse.

Irvine, Calif.-based Edwards Lifesciences Corp. unveiled results from the COMMENCE clinical study, with data showing that the company's bioprosthetic surgical aortic valves featuring its Resilia tissue platform continued to demonstrate favorable safety and hemodynamic performance through a median of four years follow-up.

Boston Scientific Corp., of Marlborough, Mass., has gained a green light from the U.S. FDA for its Vici Venous Stent system to treat iliofemoral venous obstructive disease. The approval was based on data from the VIRTUS study in 170 patients that evaluated the stent in relation to predefined objective performance goals in those with a clinically significant obstruction in the iliofemoral venous outflow tract.

CINCINNATI – U.S. FDA reorganization took center stage Wednesday at FDA/Xavier MedCon 2019, with Jeff Shuren, director of the Center for Devices and Radiological Health, unveiling the official implementation of the new Office of Product Evaluation and Quality (OPEQ), something the agency also reported the same day. "We've been trying to apply – and have been applying – a total product life cycle approach for our decision making for many years. However, organizationally, we have not been well-structured to support that approach," Shuren told attendees of the conference, which is taking place this week in Cincinnati.