A low-intensity transcranial ultrasound stimulation device, developed by Sonomind SAS, was proven to be safe and effective in treating patients suffering from drug-resistant depression. The results of a study published in Brain Stimulation showed a 61% reduction in the depressive symptoms of patients treated with the device over a five-day period, with no serious adverse events. Read More
Mirvie Inc. continues the development of precision medicine for pregnancy-related conditions with its Encompass blood test to predict preeclampsia risk and individualized support to head off the life-threatening complication that affects one in 12 pregnancies. The test, which received U.S. FDA breakthrough device designation in 2022, is now available to order online with clinician review via telehealth. Read More
U.S. Health and Human Services Secretary Robert Kennedy made his first appearance May 14 before the Senate Health, Education, Labor and Pensions (HELP) Committee since his January confirmation hearing. Chaos, testy arguments, accusations and surprising agreements ensued. Read More
Companies new to the world of U.S. FDA regulation are often unaware of how detailed the agency’s inspections are, which might be the case with the October-November 2024 inspection of Noah Medical Inc. Read More
Immunity is not a function most people particularly associate with the liver. But because of its connection to the gut, the liver is exposed to bacterial metabolites as few other organs are. And when either the liver or the gut is not functioning well, it can adversely affect immunity as well. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 10x Genomics, Bruker, Cervos, Genoox, Median Technologies, Pager Health, Protera Health, Qiagen, Ranfac, Synchron, Telesair, Tri-anim Health. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brightheart. Read More
