In a split decision delivered June 21, the U.S. Supreme Court resolved the dilemma created by the constitutional non-reviewability of decisions rendered by the Patent Trial and Appeal Board (PTAB). The Supreme Court’s solution is to make those PTAB decisions reviewable by the director of the Patent and Trademark Office (PTO), although the PTO director’s discretion regarding which PTAB cases should be reviewed may itself prove highly controversial in the months and years to come.
Shenzhen Mindray Bio-Medical Electronics Co. Ltd. plans to release a couple of new imaging solutions this month as part of continued and rapid growth in its home market and globally. The first to be unveiled by the Shenzhen, China-based company is the Resona I9, its latest general imaging diagnostic ultrasound system.
Paris – Cardinor AS has secured $1.44 million to commercialize development of a novel ELISA (enzyme-linked immunosorbent assay) blood test that uses secretoneurin as a blood-based biomarker for heart disease and sudden cardiac arrest. London-based Intuitive Investments Group plc participated in this third seed round, along with existing Belgium and German investors.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Masimo, Medtronic, Onward Therapeutics, Qualimed, Sensome.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aiforia, Alibaba Health, Anatech, Avacta Group, Berry Oncology, Calibre Scientific, Cancer Diagnostics, Efferent Health, Epredia, Madison Core Laboratories, Paige, Parvizi Surgical Innovation, Predictive Health Diagnostics Company, Raysearch, SHL Telemedicine, VNA Care.
A new FDA discussion paper addresses cybersecurity issues specific to the servicing of medical devices, with the goal of guiding the conversation about potential challenges and opportunities. It coincides with a larger agency initiative to provide more clarity on servicing.
It’s not unusual for women to have some uterine contractions during pregnancy. Many of these go unnoticed, but others can be strong and feel like labor. Distinguishing between normal contractions and those that are not can help ensure women at risk of preterm labor get the extra medical care they need. To that end, Tel Aviv-based Nuvo Group Ltd. has launched an FDA-cleared uterine activity (UA) module on its Invu remote monitoring platform.