The company’s dual drug-device development pipeline is progressing well, with the company expecting its device, the Alfapump, to hit US clinics in 2025.
Sequana Medical is working on both device and drug-based approaches to dealing with fluid overload in the body.
Recently, Sequana was awarded FDA clearance for an investigational new drug application (IND) of its direct sodium removal (DSR) 2.0...
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Medtech Insight spoke with Sanjay Kakkar, Tensive CEO, about the firm’s breast tissue regeneration implant and its surgical benefits, including a reduced operation time of 74 minutes. He anticipates regulatory approval for Regenera in early 2027.
After receiving US FDA clearance and reporting first successful use at Mayo Clinic, the Silicon Valley start-up plans to partner with leading centers to transform needle-based procedures with its robotic system starting with urology, then expand into other specialties, the CEO said.
SafeHeal has secured an additional €10m for its Colovac device, bringing its total funding to €97.5m. Led by Asabys Partners, this funding offers both economic and clinical benefits, potentially reducing costs and complications associated with temporary stomas.
Brazil is planning to update its National Clinical Research Action Plan to make the country a more competitive location to conduct R&D.
Brazil is planning to update its National Clinical Research Action Plan to make the country a more competitive location to conduct R&D.
Roche’s scanners have been integrated with PathAI’s AISight Dx system. The system’s FDA-cleared PCCP allows new components to be validated and integrated without additional FDA clearance. Eric Walk, chief medical officer, hints at future biopharma companion diagnostic collaborations.
Salient's inflammatory bowel disease test, built on the start-up’s Signal platform, is planned to launch in March 2026. The company leverages rich data from existing wellness tests to develop signatures, focusing on conditions that are often misdiagnosed and disproportionately affect women.
