Eisai Co. Ltd. and Oita University in Oita Prefecture, Japan, developed a first-of-its-kind machine learning model to predict amyloid beta accumulation in the brain using a wristband sensor. The model, which collects biological and lifestyle data from daily life, is expected to enable screening for brain amyloid beta accumulation to identify those at risk for Alzheimer's disease, particularly because amyloid beta begins to accumulate in the brain about 20 years before the onset of the disease. Read More
The U.S. FDA might still be seen as the premier med tech regulatory entity in the world, but the agency is badly outnumbered by companies in the life sciences, which are pumping out artificial intelligence algorithms at a breathtaking pace. Further, the FDA must also avoid being lapped by industry in connection with the regulatory novelty known as the predetermined change control plan, a challenge that put the agency’s device center in scramble mode for essentially the entirety of calendar year 2023. Read More
Cardiomech AS raised $13 million in fresh capital via a convertible loan agreement that will go towards developing its transcatheter mitral valve chordal repair technology. The round was heavily oversubscribed, indicating investors' expectations that the company’s technology may be a first-line therapy for patients suffering from degenerative mitral regurgitation. Read More
Med-tech financings exceeded $1 billion for the third consecutive month, reaching a total of $1.07 billion in transactions in December. In November, med-techs raised $1.02 billion, with $1.23 billion raised in October. The overall average for financings in 2023 stands at $1.47 billion per month, down from a monthly average of $3.19 billion the previous year. Read More
The first patenting from 4M Biotech Inc. describes a wound dressing with incorporated color-changing pH sensors that are continuously responsive to the pH of wounds or wound exudate. Read More
New hires and promotions in the med-tech industry, including: Bio-Techne, Delfi Diagnostics, Glytec, Healthy.io, Illumina, Simbiosys, Zimmer Biomet. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Nanowear. Read More
