Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Elucent Medical, GE Healthcare, Intalight.
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.
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.
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.
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.
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