Boston Scientific has received 510(k) clearance, launching it into a $1bn market where single-use scopes are increasingly recommended to prevent spread of infections.
Boston Scientific Corp.’s Exalt Model-B (Exalt-B), a single-use bronchoscope, has been cleared by the US Food and Drug Administration. The device is only the second such bronchoscope on the market and is designed to help reduce the growing number of hospital infections.
The company announced it had received 510(k) clearance for the Exalt-B on 10 August. Development of the device is the...
GE HealthCare launches bkActiv S series – part of the bkPortfolio family of Active Imaging systems.
The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.
The Development Bank of Wales and London-based Parkwalk Advisors led an investment round of £5m, almost doubling Ceryx Medical's total investment to date.
SS Innovations reported its first SSi Mantra 3 robotic cardiac surgery in South America as it prepares to file for US FDA de novo clearance and a CE mark. The firm aims to challenge Intuitive Surgical with a lower-cost, flexible system targeting US and European markets.
