The U.S. FDA's breakthrough devices program continues to rack up new designations, this latest one for Shréis Scalene Sciences LLC's Cytotron device. The noninvasive whole-body system, which is intended to break down or interrupt the growth of malignant tumors, is already CE marked and available in the European Union. Read More
Robotics has been a hot topic over the last year or so, from product unveilings to M&A. Now, Xact Robotics Ltd., which has a presence in Hingham, Mass., and Caesarea, Israel, has reported that its first robotic system gained clearance in the U.S. for use during computed tomography-guided percutaneous interventional procedures. Read More
The U.S. Court of Appeals for the Federal Circuit has decreed that the regulations governing appointment of judges to the Patent Trial and Appeal Board (PTAB) violate the U.S. Constitution – a decision that gives a medical device maker a new bite at patent litigation, but which also raises the question of whether a large number of PTAB decisions will have to be relitigated. Read More
LONDON – Nyxoah SA reported positive clinical results for Genio, its lead-free, battery-less implantable neurostimulation device, showing it resulted in a significant reduction of the severity of obstructive sleep apnea (OSA), the world's most common sleeping disorder. Read More
HONG KONG – South Korean AI-based biotech Azoth Bio Inc., of Seongnam, Gyeonggi-do, and biopharmaceutical venture Wellmarker Bio Co. Ltd., based in Seoul, have signed a memorandum of understanding for cancer drug R&D and commercialization. Under the agreement, the two entities will use Azoth's AI-powered platform to develop Wellmarker's cancer treatment candidates. Read More
For more than two decades, the BioWorld team has understood that you have a vital "need to know" to stay competitive, to bring your novel ideas forward through the long cycle of development, testing and commercialization. Now we've upgraded our presentation of news and analysis to better enable your missions. On Nov. 19, we're migrating to a fantastic new platform. Read More
