The Helsinki-based company had expected stroke rehabilitation to be the first FDA-cleared indication for its Navigated Brain Therapy system, but while more data is collected for that program, it is pursuing a 510(k) clearance for NBS to treat major depressive disorder and plans to build a US salesforce to market NBS for therapeutic indications.
Nexstim PLC has filed a 510(k) to US FDA for its NBT (Navigated Brain Therapy) transcranial magnetic stimulation (TMS) therapy system to be cleared for treating major depressive disorder.
Major depressive disorder is a chronic condition affecting 2%-5% of the population in developed countries. Current therapies, based on drugs...
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Exact Sciences has entered into an exclusive licensing agreement with Freenome, stipulating clinical benchmarks and a first-line rating in the USPSTF guidelines. Medtech Insight interviewed screening CMO Paul Limburg about CRC screening and Exact’s strategy on liquid biopsy.
The FDA's Device Clinical Trial Snapshot Pilot, aimed at increasing trial transparency and diversity, has been canceled following President Trump’s anti-DEI executive order. Critics warn this may hinder trial transparency, impacting public health and demographic data accessibility.
Daye is launching an at-home reproductive hormone testing service in the UK, utilizing a painless upper arm blood collection method. The product’s UKAS lab accreditation helps build credibility with healthcare providers.
The Elecsys pTau181 test, which requires only a blood sample, provides a less invasive alternative to cerebral spinal fluid procedures. A negative result could rule out Alzheimer’s and help patients avoid further testing with CSF or PET scans.
Ultromics has secured $55m in Series C funding to advance its AI tool, EchoGo, which detects undiagnosed heart failure. The company's focus on diseases with available treatments resonated with investors.
Siemens Healthineers anticipates €400m-€500m tariff impact by 2026 but says it will mitigate losses through structural changes and pricing. Despite a revenue decline in diagnostics due to China’s VBP, diagnostics transformation activities, including cutting product, were “successful."
Germany’s CorTec has implanted its wireless brain-computer interface in a stroke patient, launching a trial to test safety and whether brain stimulation during physical therapy can help restore movement where traditional rehab has failed.
