The speculation as to the status of Michelle Tarver, the acting director of the U.S. FDA’s device center, is officially over despite disclaimers at. The outgoing director, Jeff Shuren, said Tarver “will make a great center director” in remarks during an Oct. 17 public appearance, thus cementing Tarver’s role at FDA.

The med-tech industry has been keen to see government fill in the so-called valley of death for breakthrough medical devices for some years, and 2024 may be the year it is finally done. Scott Whitaker, president and CEO of the Advanced Medical Technology Association said in an Oct. 16 press briefing that a House bill may pass during the upcoming lame duck session, bringing to a close an effort that has been the better part of a decade in the making.

The U.S. Medicare program has a notorious problem with regard to coverage of digital products and software as a service, but the agency is dependent on Congress to add new benefit categories via legislation.

The saga of the EU's Medical Device Regulation (MDR) is far from over, but stakeholders were treated to another related dose of reality in a session at this year's Med Tech Conference here in Toronto. Several panelists pointed to a lack of harmonization regarding notified bodies' interpretation of the regulation, but Stryker Inc.'s Michel Marboeuf said this problem flows to some extent from a lack of harmonization among the member states' competent authorities, a condition that is likely to resist treatment in the near term.

Third-party litigation funding has been a source of controversy in the U.S. over the past decade, but the practice drew little national scrutiny up to now.

The U.S. FDA’s device center disclosed its guidance ambitions for this new fiscal year – a list that includes the usual A and B lists for draft and final guidances. However, the agency now has an “under construction” list of guidance ambitions, the status of which is entirely reliant on the agency’s resources.

Edwards Lifesciences Corp. made a splash recently with the U.S. FDA approval of the Evoque tricuspid valve replacement device, but is also pressing Centers for Medicare and Medicaid Services to provide a coverage framework for this class of devices.

China’s National Medical Products Administration wrapped up a revision of its device classification procedures, providing entries into one of the world’s largest markets a mechanism for obtaining means for determining the risk of a novel device type.

The U.S. Patent and Trademark Office opted to allow the 2.0 pilot version of the After Final Consideration Program to expire, bringing to an end a program that ran for longer than a decade.

The controversy over conflicts of interest for Jeff Shuren, formerly the director of the U.S. FDA’s device center, reached Capitol Hill and may lead to an executive branch investigation into the matter.