Brainomix Ltd. received U.S. FDA clearance for its Brainomix 360 E-aspects tool, a fully automated AI-imaging solution for stroke assessment. Powered by explainable AI, the Brainomix 360 E-aspects tool, which is already CE-marked, assesses non-contrast CT scans to automatically generate a score and measures the volume of ischemic signs. It also features an overlaid heatmap to visually assist clinicians when treating stroke patients. Read More
Edwards Lifesciences Inc., has joined Apple Inc., and several tech companies in suing the U.S. Patent and Trademark Office (PTO) over PTO’s administration of the inter partes review (IPR) process in a lawsuit that reached the Court of Appeals for the Federal Circuit. The court recently rejected the challenge as to whether the PTO is empowered by the statute to determine whether an IPR could be instituted, but the agency may be forced to engage in the clunky rulemaking process to formally encode the so-called Fintiv standard for acceptance of IPRs. Read More
Early-stage venture capital firm Karista SAS reported the third edition of its European digital health funds mapping report. This mapping included all funds with global headquarters in France, Germany, Spain, Italy, the U.K., Netherlands, Austria, Luxembourg, Belgium and the Nordics. Read More
As Medtronic plc. is fond of pointing out, the garage inventor has been the stuff of legend in U.S. business lore, providing a wide range of economically impactful inventions over the two-plus centuries since the U.S. patent system came into being. Read More
The dominoes are falling on European clinical trials as the unintended consequences of the EU’s In Vitro Diagnostics Regulation take hold. Last year’s implementation of the regulation has resulted in the delay of up to 160 drug trials to date, with as many as 420 trials expected to be delayed over the next three years, according to an EFPIA member survey. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Clario, Epic, Fluoguide, Guardant Health, Glaxosmithkline, Invitae, Oxford Nanopore, Pathoquest, Progentec, Strados. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advamedica, Brainomix, Etiometry, Graymatters Health, Inspire Medical Systems, Viz.ai. Read More
