The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the EndoGastric Solutions’ EsophyX Z device. Designed for compatibility with 7.5mm SerosaFuse Implantable Fastener cartridges, EsophyX Z allows physicians to reconstruct the gastroesophageal valve and then secure tissue with a trigger-like handle – making the device similar to surgical stapler-like devices.
EsophyX Z will enter commercialization in the U.S. during Q3. Additionally, it is being used in the American Gastroenterological Association’s STAR Registry, which will provide the first real-world data comparing patient outcomes after traditional laparoscopic surgery and transoral incisionless fundoplication (TIF) with the EsophyX device.
“The EsophyX Z design provides reduced device operational steps,” says Darren Crow, general manager, EndoGastric Solutions. “In addition to a reduction in fastener deployment steps, the stylet tips on exiting the device are now shrouded at the tip of the tissue mold.” www.endogastricsolutions.com
$20.3 million in Series A financing for Cambridge Medical Robotics
Cambridge Medical Robotics Ltd (CMR), a company developing a next-generation robotic system for universal minimal access surgery, has secured $20.3 million in a Series A funding round from new investors including ABB Technology Ventures (ABB), LGT Global Invest (LGT), and Cambridge Innovation Capital (CIC).
Following the successful start of clinical cadaveric trials in June 2016, investment proceeds will enable CMR to continue toward becoming a global medical device manufacturer. Specifically, the proceeds will be used to progress development and commercialization of its medical robotic technology and to expand the team in preparation for regulatory approval.
In association with the financing, CMR has appointed to its board of directors, Dr. Robert Tansley of CIC, Massimo Muzzi of ABB, and Egor Kulkov of existing investor Escala Capital.
“The financing enables us to increase our engagement with our target market and prepare for commercialization,” says Martin Frost, CEO of CMR. “We welcome the decision of ABB, a global leader in robotics, to cooperate with CMR in areas ranging from component sourcing to manufacturing as we now enter a critical phase in production and commercialization.” www.cmedrobotics.com
FDA approves rechargeable battery options for Med-El’s
Med-El has earned FDA approval of standard- and micro- rechargeable battery options for the Sonnet Audio Processor. When used with micro, Sonnet will be the lightest audio processor on the market.
The standard rechargeable battery provides up to 10 hours of listening, and is compatible with WaterWear. The discrete micro-rechargeable battery allows the Sonnet to weigh 8.1g on the ear. Both battery packs will be available in Sonnet accent colors. The batteries can be quickly charged and easily changed. The Sonnet Charging System can charge up to four batteries at once through a USB connection.
Med-El also has introduced the Mini Battery Pack for Sonnet, which allows users to connect Sonnet to a body-worn battery pack that provides up to 37 hours of use from one AAA battery. www.medel.com