An increasing number of European med-tech companies are first seeking regulatory approval from the U.S. FDA because of the growing backlog and frustrations with requirements under the new regulatory framework of the EU Medical Device Regulation (MDR), which has been described as “not working.”
Eitan Medical Ltd. plans to launch its Avoset infusion system into the U.S. later this year, following the introduction of the multi-therapy ambulatory infusion system into the European market. The connected Avoset infusion system is expected to transform the way patients receive treatment in post-acute care, as it enables remote monitoring of infusion treatment which will enhance patient safety and improve the user experience.
Med-tech companies often use robotics and artificial intelligence (AI) to transform healthcare systems and improve patient outcomes. However, the current hype around generative AI, such as ChatGPT, and the explosion in the use of data are raising questions around regulation, reimbursement, and whether AI and robotics are the right tools for certain jobs, participants heard at the LSX World Congress in London.
Companies such asMedtronic plc have become risk averse and are unlikely to takeover early stage medtech firms, Ori Hadomi, vice president strategic initiatives & partnerships, at Medtronic, told delegates at the LSX World Congress in London. Hadomi, who joined Dublin-based Medtronic after his firm Mazor Robotics Inc. was taken over by the company in a $1.64 billion deal in 2018, told early-stage startups “don’t waste their time” in approaching the company.
Med-tech companies are facing a new reality of high interest rates, inflation, bank failures, and geopolitical turmoil that are impacting financing and M&A opportunities. To secure finance and attract partnership deals they must keep their product simple, focus on proof of concept and ensure that it has quality, delegates at the LSX World Congress in London heard during a panel presentation.
Using direct current to stimulate a chronic wound can help it to heal up to three times faster, researchers from Chalmers Institute of Technology, Sweden, and the University of Freiburg, Germany, found. Working from a well-known hypothesis that the skin is electrostatic, the researchers engineered a microfluidic biochip on which skin cells were cultured. They then made tiny wounds in two cells. One was allowed to heal naturally while the other was stimulated with electricity.
Ultromics Ltd. has been granted a U.S. FDA breakthrough device designation for its artificial intelligence (AI)-enhanced platform to aid early diagnosis of cardiac amyloidosis. Echogo Amyloidosis uses AI to analyze echocardiograms and detect the presence of cardiac amyloidosis, using a single commonly acquired ultrasound view of the heart. The platform was developed with the support of Janssen Biotech Inc., part of the Janssen Pharmaceutical Companies, a unit of Johnson & Johnson.
The Memed BV test, developed by Memed Diagnostics Ltd. to distinguish between bacterial and viral infections, offers an accurate diagnosis of the infection in children, and reduces the unnecessary prescription of antibiotics by physicians, according to a study published in the journal, PLOS One.
The €15 million (US$16.45 million) loan Smart Reporting GmbH recently received from the European Investment Bank (EIB) will take the company a “long way” as it looks to expand the use of its artificial intelligence (AI)-based medical documentation technology which “helps clinicians improve their workflow and patients to get better care,” co-CEO Peter Vanovertveld, told BioWorld.
Biocartis Group NV recent entered an agreement with Apis Assay Technologies Ltd. to develop Apis’ breast cancer subtyping assay on its Idylla platform, is part of the Belgium company’s mission to bring complex molecular testing to as many patients as possible, outgoing Biocartis CEO Herman Verrelst, told BioWorld. The Idylla platform is a fully automated, real-time PCR based molecular testing system. With the technology failing to penetrate the U.S. market, and the share price tanking in recent years, the Belgium-based company recently appointed Roger Moody to the top job, effective Apr. 24, 2023.
