Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
Smiths Medical is looking to expand its workforce by up to 35 employees as it fills out its expanding facility in Connecticut.
The device maker dedicated $1 million to adding a 20,000 square-foot facility to its existing 125,000 square-foot plant in Southington. The plants are just a street apart, according to a local report. Read more
The Centers for Medicare & Medicaid Services issued a final coverage decision for transcatheter mitral valve replacement devices, a decision that currently only affects Abbott’s MitraClip implant.
The new memo largely parallels the proposal made in May, granting “Coverage with Evidence Development,” meaning the devices will be reimbursed but hospitals must agree to participate in a patient registry. Read more
A federal appeals court last week upheld the dismissal of a whistleblower lawsuit accusing Stryker, Orthofix, I-Flow Corp. and DJO Global of illegal off-label marketing of their respective pain pumps.
Dr. Lonnie Paulos, a Florida orthopedic/sports surgeon who once consulted for Stryker’s orthopedic business, filed the qui tam lawsuit in 2011, claiming that Stryker sales reps pitched him on unapproved pain pump uses and that he knew of colleagues who were similarly approached. The suit accused the device makers of explicitly marketing pain drug pumps for use in articulating joints such as the shoulder and knee, despite the FDA’s rejection of the devices for orthopedic uses. Read more