The Centers for Medicare & Medicaid Services has cracked open its coverage policy for transcatheter aortic valve replacement devices a second time, and a wide range of stakeholders are providing feedback. Where the agency will land on questions such as the need for continued evidence development is difficult to predict, however, given that the agency is hearing anything but unanimity on the question.

The U.S. FDA has endorsed ISO 14971 for risk management for medical device manufacturers, but there’s nothing compulsory about industry’s use of this standard. Nonetheless, Sarah Moore, principal program lead at NSF, told BioWorld that adoption of 14971 is still the most seamless way to demonstrate proper risk management practices to FDA field investigators, given that the alternative is almost always more work for both sides during facility inspections.

Distalmotion SA recently secured a strategic investment from Johnson & Johnson for its robotic-assisted surgical system Dexter, amid an increase in demand from ambulatory surgery centers for such platforms. The deal follows Distalmotion’s $150 million in a series G financing, and coincides with J&J’s recent submission of its own robotic surgical system, Ottava, to the U.S. FDA., for clearance.

Boston Scientific Corp. looked ready to keep steamrolling down the acquisition path, carrying the momentum from last year, with the news that it is acquiring Penumbra Inc., a company that makes devices for interventional therapies to treat vascular conditions such as stroke and aneurysm, for a whopping $14.5 billion.