Stereotaxis Inc. recently received CE mark recertification for all its devices currently available in Europe under the new Medical Device Regulation (MDR) regulatory framework. The MDR has replaced the European Medical Device Directive and includes more stringent standards but meeting the new requirements comes with frustrations and costs for many companies. Read More
Two companies – Head Diagnostics Ltd. and Octave Bioscience Inc. – identified biomarkers that could provide objective assessments of disease progression and response to treatment for patients with multiple sclerosis. Read More
The U.S. Department of Justice announced May 29 that Innovasis Inc., of Salt Lake City and two of the company’s executives have agreed to pay $12 million over allegations of payment of kickbacks to surgeons. Read More
Germline variants that did not affect gene function nevertheless affected multiple aspects of breast cancer risk, via their visibility to the immune system and its reactions. Perhaps most surprisingly, the same genetic constellations that were protective at the very earliest stage of breast cancer, stage 0 or ductal carcinoma in situ, were associated with worse outcomes once a tumor had become invasive. Read More
News comes from the U.K. Intellectual Property Office at the beginning of May 2024, where Ethicon, a Johnson & Johnson MedTech company, applied for five additional years patent protection for its Ethizia hemostatic sealing patch, whose embedded Pox polymer system dehydrates blood and accelerates the coagulation cascade to in occur in seconds, forming a tight yet flexible seal that maintains a barrier to bleeding. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cydar, Johnson & Johnson, Shockwave, Sharps Technology, Nephron, Personalis, Tempus. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Innovoyce, Watmind. Read More
