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.
Mediwhale Inc. closed a $9 million series A round that will see the company take its artificial intelligence (AI)-powered retina scans to prevent heart and kidney diseases to the U.S. market.
Oso-AI SAS raised $10.7 million to develop its artificial intelligence (AI)-driven augmented ear for frail people and their caregivers. This series A financing round was led by its historical shareholders Innovacom SAS, Novinvest Partners SAS and Breizh-up, which is the co-investment fund of Brittany region financed by the European Regional Development Fund and managed by UI Investment SAS. Cemag Invest Partners SAS has joined these three historical investors. This operation follows a first round of financing of $4.4 million which closed in September 2020.
Four U.S. government agencies have issued an advisory regarding bias in the use of artificial intelligence (AI) and other automated systems, the scope of which includes software products that “make decisions.” The four agencies have pledged to use their enforcement powers to “protect individuals’ rights regardless of whether legal violations occur through traditional means or advanced technologies,” all of which sends a signal to developers of medical software that the FDA is not the only federal government agency that will be looking over their shoulder to evaluate the risk of bias in those algorithms.
The U.S. Supreme Court has declined to hear a case that tests the notion that artificial intelligence (AI) can be an inventor, a development that may be nothing more than the beginning of the AI-as-inventor story under U.S. law. The Patent and Trademark Office’s (PTO) April 25 webinar on the subject included some remarks that AI could be used to produce a tsunami of potentially duplicative patent applications, but the event demonstrated that there is almost no at-large support for AI-as-inventor, suggesting that the status quo will stand for the time being.
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.
The U.S. Supreme Court has declined to hear a case that tests the notion that artificial intelligence (AI) can be an inventor, a development that may be nothing more than the beginning of the AI-as-inventor story under U.S. law. The Patent and Trademark Office’s (PTO) April 25 webinar on the subject included some remarks that AI could be used to produce a tsunami of potentially duplicative patent applications, but the event demonstrated that there is almost no at-large support for AI-as-inventor, suggesting that the status quo will stand for the time being.
The gastroenterology team at the Paoli-Calmettes Institute in Marseille, France is conducting a therapeutic trial using G-Eye, the latest generation of colonoscope from Hanofar, Israel-based Smart Medical Systems Ltd. “The aim is to increase the detection rate of polyps thanks to a new type of device that can be connected to the current colonoscopes on the market,” Jean-Philippe Ratone, the principal investigator of the study and gastroenterologist at the Paoli-Calmettes Institute told BioWorld.
The U.S. FDA’s draft guidance for predetermined change control plans (PCCPs) is a groundbreaking guidance that was enabled by legislation that allows the filing of PCCPs with all device types, not just software as a medical device (SaMD). However, a member of the FDA team acknowledged recently that this new approach to device change management could require that the agency revisit existing guidances such as a guidance for when to file a new regulatory submission for 510(k) devices, thus heralding a series of guidance revisions that may take several years to unwind.
