The U.S. FDA has guidances on the books for dental products, but the it unleashed a quartet of guidances – ceramics and cements used in dental procedure – for dental products on the final Friday of September 2024. The agency also issued a guidance without comment – unusual for the FDA – for the well-known, terror-striking pneumatic dental hand tool.

The Nov. 20-21 meeting of the digital health advisory committee will discuss the use of generative artificial intelligence algorithms in medical devices with a focus on the total product life cycle – a theme that suggests a concern on the agency’s part regarding the reliability of these algorithms’ output.

The U.S. Court of Appeals for the Federal Circuit shot down Planmeca’s argument that expert testimony provided by Osseo was disqualified because the expert was not a PHOSITA at the time the patented articles were developed, leaving Planmeca with a negative verdict in excess of $2 million.

The U.S. FDA issued a draft guidance for premarket applications for class II bone grafting devices, a policy that would supplement a guidance issued nearly two decades ago.

Orthocell Ltd. landed its first global licensing deal for its regenerative collagen medical device with Biohorizons Inc., one of the largest dental implant companies in the world. The licensing deal comes on the heels of the Perth, Australia-based company reporting final data from its nerve reconstruction study that showed patients continued to improve between 12- and 24-months post-treatment with its regenerative nerve repair device Remplir.

PARIS – Wishbone SA closed a $3 million funding round, which should allow it to obtain the CE mark prior to launching its range of products in Europe based on bone regeneration technology for reconstructive dental surgery. “Thanks to this round, we are ramping scale and moving from R&D to the commercialization phase in Europe,” Daniel Bee, CEO of Wishbone, told BioWorld.