The FDA’s two-day advisory hearing yielded recommendations for risk designation for a number of product types, such as plunger-like joint manipulators, which received a unanimous endorsement for a class III designation. The advisory panel was split on the risks associated with electro-acupuncture stimulators, which the FDA must now decide whether to classify as a class III device, a move that would force a number of existing devices into clinical trials for an expensive and time-consuming PMA application.

Eyeyon Medical Ltd. has won CE mark approval for its flagship product, Endoart, a synthetic implant that replaces the human endothelium, which the body can’t regenerate. Designed to treat chronic corneal edema, it could help to reduce the long wait times for human donor corneas. Approval was based on a first-in-human trials involving 22 patients who received Endoart implants and were followed for 24 months.

Heralded as a potential turning point for U.S. innovation in the 21st century, the U.S. Innovation and Competition Act, S. 1260, is a big step closer to becoming law. The Senate voted 68-32 June 8 to pass the sweeping $250 billion bipartisan bill intended to give the U.S. an edge over China when it comes to innovation and investment in several critical industries, including artificial intelligence, biotechnology and quantum computing.

The European Commission (EC) unveiled on Monday its new joint implementation and preparedness plan for the European Union’s In Vitro Diagnostic Regulation (IVDR). It sets forth priority actions, noting “the implementation of the IVDR has proven to be a very challenging task,” exacerbated in the response to the COVID-19 pandemic “despite the efforts undertaken by all” to transition.

The FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program promises to smooth out the path from development to market access for device makers, but there are a few potential biocompatibility hiccups. Among these is that any customized preparation of a sample for biocompatibility testing would render that product ineligible for the ASCA pilot, but a product containing nanomaterials is also not eligible because of concerns over biocompatibility.

HONG KONG – Singapore authorities have given provisional approval for a locally developed breath test for COVID-19. The test is developed by Breathonix Pte Ltd., a spin-off company from the National University of Singapore through its Graduate Research Innovation Program. The company said its Brefence Go COVID-19 breath test system was the first test of its kind to secure provisional authorization in Singapore.

Imagine an orthopedic implant that not only accelerates bone healing but also captures data to support real-time clinical decisionmaking. That’s the vision of Intelligent Implants Ltd., whose Smartfuse system recently won FDA breakthrough device designation. The first indication is for lumbar spinal fusions.

LONDON – The U.K. health technology assessment agency, NICE, has called for a halt to the use of transvaginal laser therapy in the treatment of urinary stress incontinence and vaginal atrophy, saying there is not enough evidence of long-term safety, or proof that the procedures are effective.