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.

Precipio Inc. reported the launch of its Hemescreen anemia panel, part of a suite of diagnostic tests that run on the Hemescreen physician office laboratory (POL) testing system. The new panel is intended to help physicians tackle a difficult challenge – deciphering anemias of unknown cause.

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.