Though the Ukraine war has had an impact on the availability of medical devices and diagnostics, a number of companies based in the U.S. and Europe have announced measures to ensure their products will reach the war-torn nation. Device companies are donating millions to nongovernmental organizations for humanitarian assistance, while the Advanced Medical Technology Association (Advamed) said its member companies are tracking the situation and are eager to pitch in with desperately needed supplies and medical equipment. Read More
As conflict escalates and medical supplies dwindle, Ukrainians are urging the international health care community to send medical equipment and medication. In a webinar, a panel of speakers discussed which medical supplies are desperately needed to address the growing humanitarian crisis. Anna Levchuk, vice president of market access, commercialization and health care at Clarivate and a member of the supervisory board for Medical Procurement of Ukraine, moderated the panel. Read More
Axonics Inc. received FDA approval for its recharge-free sacral neuromodulation (SNM) implantable neurostimulator (INS) for bladder and bowel dysfunction. The F15’s primary cell requires no recharging or replacement for more than 15 years with normal use or 20 years at lower energy settings and the system is compatible with 1.5T and 3.0T full body magnetic resonance imaging scans. Read More
Singular Health Group Ltd. entered a 50-50 joint venture in Macau that will explore the potential of Singular’s Scan to Surgery software for the East Asian market, which the company has long seen as a key opportunity for its 3D software and medical 3D printing ambitions. Read More
Experts at the Paris Cardiovascular Research Center (PARCC) have designed an artificial intelligence-based system to predict kidney allograft survival. This model was validated in an observational multicohort study in Europe, the U.S. and South America, as well as randomized trials and results were published in The Lancet Digital Health. Read More
Medical devices and diagnostics are patent-dependent items, and companies may be able to avail themselves of extensions of their patents due to the time taken for FDA regulatory review. The U.S. Patent and Trademark Office announced March 8 that it had granted Neovasc Medical Ltd. a one-year extension of the term of two patents for the company’s flagship Reducer device, thus giving the company one additional year of market exclusivity to obtain the FDA’s approval for the device. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Clinithink, Fox Biosystems, Harald AI, Heartbeat Health, Immunovia, Katalyst Diagnostics, Macatt Medica, Pixcell, Vygon. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics, Quotient, Saluda Medical, Sense. Read More
