The compromise pre-market provisions merge components of a pre-market “scrutiny” procedure proposed last year by the European Commission and proposals from legislators seeking even stricter pre-market oversight. The CEO of the industry trade group Eucomed calls it a “PMA in disguise carried out on a case-by-case basis” and says it will harm innovation and patient access to new technologies if adopted.
Discrepancies between FDA-approved labeling and national Medicare coverage decisions are frequent, particularly for medical devices, where CMS tends to be more restrictive than FDA, researchers reported in Health Affairs. The findings have implications for the parallel review program.
In orthopedics’ next generation, start-ups believe it will be advances in information, gathered by implanted sensors, that will yield the greatest improvements in outcomes, not hardware. We profile OrthoData and Ortho-tag.
In a regional deal, AstraZeneca licensed rights to FibroGen’s renal candidate in an alliance worth $815 million; Elan finally agreed to an $8.3 billion takeover by Perrigo; biopharma financing totaled $7.1 billion and $2 billion in June and July, respectively, while device fundraising reached $325 million and $316 million in the same months.
When it comes to regulating mobile apps, “it’s not about the platform, it’s about the functionality,” says CDRH Director Jeffrey Shuren of the long-awaited mobile medical apps final guidance.
FDA detailed its proposal for a new “pre-decisional IDE review process” in a revised draft guidance issued June 14. The voluntary process would occur prior to IDE submission and would offer companies comprehensive feedback on where their study plans fall short in gaining IDE approval and in ultimately gaining marketing approval.
MedPassage Inc. has created an ecommerce site where hospitals and physicians can order the medical implants of their choice directly from a larger variety of manufacturers. By eliminating the sales rep, at least for certain routine types of implants with which surgeons are familiar, medical centers will pay substantially less than the average selling price of the implants.
Wright Medical’s decision to sell its hip and knee business wasn’t entirely unexpected. The buyer, the Chinese company MicroPort, may have surprised some, but changes in orthopedics and the device industry as a whole could make such deals more common.
Whether they support centralized review or not, device manufacturers want CMS to provide more detail on how the process would work – including timelines, the extent of manufacturer interactions with agency staff, and how appeals would be handled.
The long-awaited independent analysis of clinical data on Medtronic’s InFuse recombinant human bone morphogenetic protein-2 (rhBMP-2) found no advantages to using it as a substitute for traditional bone grafts in spinal fusion surgery, while also revealing that the risks of rhBMP-2 may be greater than has been previously reported.
