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. Read More
The June report to Congress by the Medicare Payment Advisory Commission (MedPAC) encodes several suggestions as to how rates would be determined under the Medicare clinical lab fee schedule (CLFS), such as the use of competitive bidding for laboratory tests. That and other policy concepts earned a quick reply by the American Clinical Laboratory Association (ACLA), which said that bidding and other concepts either repeat the mistakes of recent history or fail to account for the prospect that these mechanisms could impose artificially low rates for tests and ultimately hamper patient access. Read More
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. Read More
PARIS – Gleamer SAS said Radiology published compelling results from a study evaluating the performance of its artificial intelligence (AI) system Boneview, which helps radiologists and emergency doctors detect and localize fractures. This is the first study to evaluate the performance of AI-assisted health care professionals in locating bone fractures on all appendicular X-rays. Read More
Researchers from The Hong Kong Polytechnic University (PolyU) said they have used two-dimensional nanosheets (FePSe3) to develop a biomimetic nanosheet that can monitor tumor development, treat tumors and monitor the treatment progress in real-time. With positive results from mice, the team hopes to further test it on larger animals, then move on to clinical studies. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Boston Scientific, Edevice, Genesis Medtech Group, Horcon, Inivata, Neogenomics, Pattern Computer, Predictmedix, Rakuten Medical, Shimadzu. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Co-Diagnostics, Hecin, Holista Colltech. Read More
