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.

With an eye toward streamlining reviews of increasingly complex medical products and enhancing collaboration between the FDA centers, two leading lawmakers have offered a bill that proposes the establishment of "intercenter institutes" within the agency for major disease areas.

In the wake of an FDA warning letter that highlighted complaints of sparks and visible light during the operation of a laser system and an unspecified number of deaths reported with its devices, Colorado Springs, Colo.-based Spectranetics Corp. said it intends to respond "timely and fully" to the agency by Friday. "We believe that the response will primarily involve updates in processes and documentation and will have no material impact on our business," a Spectranetics spokesperson told Medical Device Daily.

Just shy of a year after two Warsaw, Ind.-based companies combined to become Zimmer Biomet Holdings Inc. in a $14 billion merger, the company unveiled plans Tuesday to buy LDR Holding Corp. for about $1 billion, or $37 a share in cash.

Exthera Medical Corp. has closed a series B financing round, with part of the proceeds slated to go toward scale manufacturing of the company's therapeutic blood filter. The round was led by newcomer Fresenius Medical Care Ventures (FMCV) GmbH, with existing investors also participating.