A committee of the U.S. House of Representatives proposed an FDA discretionary spending bill of less than $26 billion in appropriated taxpayer dollars for fiscal year 2025.
Lunglife AI Inc. is looking for a strategic partner to help get Lunglb — its non-invasive test for the early detection of lung cancer — into the market and to the patients who need it. The company’s artificial intelligence-supported blood-based test, which identifies indeterminate lung nodules, will be game changing for early lung cancer diagnosis, Paul Pagano, Lunglife CEO, told BioWorld.
The U.S. FDA’s final guidance for device-based treatments for opioid use disorder breaks little new ground relative to the 2023 draft, including a call for the use of a randomized, controlled clinical trial that retains blinding of not just enrollees, but also of the clinicians taking part in these studies.
In June, med-tech deal values saw a modest rise to $93.07 million, up from May's $85.78 million but still lagging behind April's $172.37 million. The monthly average deal value for 2024 has now reached $139.85 million, marking an 84% drop from the 2023 monthly average of $886.13 million.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alzpath, Artelon, Autonomix Medical, Beckman Coulter, Lumicell, RF Innovations, Stryker.
Edwards Lifesciences Inc. struck three deals totaling €15 million (US$16.3 million) with Affluent Medical SAS to gain access to its mitral valve technology. Edwards secured an exclusive option to acquire Affluent subsidiary Kephalios, which makes the Kalios adjustable mitral ring, for €5 million (US$5.44 million); paid €5 million more for global, non-exclusive licensing of Affluent’s intellectual property related to its biomimetic cardiac mitral valve replacement technology; and invested a further €5 million to acquire 9.21% of Affluent.
Airs Medical Inc., of Seoul, South Korea, raised $20 million in a series C financing round to expand its artificial intelligence-based health care technology, including for better and faster magnetic resonance imaging scans for radiologists and patients.