Latest from Natasha Barrow
The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.
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."
NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.
Agent drug coated balloon, Watchman product sales, and electrophysiology (EP) business unit growth offset Acurate discontinuation and tariff headwinds. CEO Michael Mahoney shouted out coronary therapies business and answered questions on CMS proposed Ambulatory Surgical Center codes.
The medtech M&A landscape is experiencing a resurgence fueled by significant capital from private equity and venture firms, says Alex Wakefield, CRO of AcuityMD. Building strong relationships with physicians remains crucial in medtech, and defining an exit strategy early is imperative.