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.

In an effort to shore up its position in a rapidly developing market for brain-computer interface (BCI) technologies, Onward Medical NV signed an exclusive license with France’s CEA-Clinatec to use its BCI chip as part the Arc-BCI system, which restores direct communication from the brain to the spinal cord.

The $15.3 million Mindpeak GmbH recently raised in its series A funding round will allow the company to be able to accelerate the development and deployment of its AI-based solutions, Felix Faber, CEO of Mindpeak, told BioWorld.

Endostart s.r.l obtained CE marking for the expanded use of its magnetic balloon system for use in endoscopic procedures, Endorail, to enteroscopy. The company believes that Endorail, which helps resolve intestinal looping, will make the procedure more accessible and improve patient care.

The U.K. government recently unveiled £148.4 million (US$193.7 million) in funding for a raft of initiatives to tackle cancer. Backed by public and private sector investment, the projects will deliver new technologies to speed up cancer diagnosis and new methods to transform treatment.

Rhythm AI Ltd recently became the latest company to receive U.S. FDA clearance for its artificial intelligenc-based software for optimizing Atrial Fibrillation procedures.

It’s hard to know where to start in describing the biopharma applications of the 2024 Nobel Prize in Physics. It was awarded to John Hopfield and Geoffrey Hinton “for foundational discoveries and inventions that enable machine learning with artificial neural networks.”

The recent uptick in med-tech deals is a sign technologies that are solving unmet clinical needs are finally coming to fruition, Antoine Papiernik, chairman and managing partner at Sofinnova Partners, told BioWorld in an interview.

Roche AG’s new test using its temperature-activated generation of signal technology is the next step in PCR evolution, Igor Kozlov, head of Reagent Research and Design at Roche Diagnostics Solutions, told BioWorld. The Cobas Respiratory flex test can detect up to 12 of the most common respiratory viruses using a single PCR test.

Owkin Inc. partnered with Astrazeneca plc to develop an artificial intelligence (AI)-powered tool to pre-screen for germline BRCA mutations (gBRCAm) in breast cancer directly from digitized pathology slides. The companies hope that the gBRCA pre-screening solution will not only transform patients’ lives but bring value to health care systems.