Various stakeholders are urging the FDA to strengthen regulations for third-party providers that service and refurbish medical equipment being used in the field.
That call was echoed in comments to a proposed rule titled "Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers." The call for comments initially appeared in the March 4 Federal Register, but the agency extended the comment deadline to June 3 from May 3, after a number of stakeholders, including AdvaMed, asked for more time.
The urge to go on biggering and biggering and biggering has taken over the med-tech world. Barely a year after Zimmer and Biomet completed a $14 billion merger to become the second largest orthopedic device maker, the company now plans to spend another $1 billion to buy LDR and grow its spine business. Not too long ago a deal this size would have been considered a blockbuster for the medical device industry. But after two years of mega-mergers like Zimmer-Biomet, Medtronic-Covidien ($42.9 billion) and the still-pending $25 billion merger of Abbott and St. Jude Medical, this latest acquisition pales by...