Hoya (TYO:7741) subsidiary Pentax Medical announced that it won FDA 510(k) clearance for its Imagina endoscopy system and initiated the device’s U.S. launch. The Imagina system is designed to perform gastrointestinal (GI) procedures at ambulatory surgery centers (ASCs). It features a touch-screen LCD interface while eliminating the need for periodic bulb replacements. It also includes the […]
TransEnterix wants to use more AI in surgical robotics: Here’s how
TransEnterix (NYSE:TRXC) has filed a 510(k) submission to add an artificial intelligence feature to its robot-assisted surgery system in which the system can automatically move the camera for a surgeon. Surgeons have been able to move the camera on TransEnterix’s Senhance System via eye sensing. But the new Intelligent Surgical Unit would allow a surgeon, for […]
Paragonix launches SherpaPak pancreas transport system in U.S.
Paragonix Technologies today announced the FDA clearance and U.S. launch of its SherpaPak pancreas transport system, which the company says is able to provide “unprecedented thermal and physical protection” during the transportation of donor pancreases slated for people with diabetes. “The donor pancreas is highly susceptible to cold and compression injury during transport. Technologies that […]
PhotoniCare wins FDA nod for imaging tech to spot ear infections
PhotoniCare announced today that it won FDA 510(k) clearance for its TOMi Scope for non-invasive imaging of the middle ear to spot ear infections and more. The TOMi Scope is designed to determine the presence or absence of fluid in the middle ear, as well as to characterize the fluid type, by using optical coherence […]
FDA reduces controls on electrical stimulation devices for anxiety, insomnia
The FDA recently downgraded the cranial electrical stimulator (CES) devices designed to treat anxiety and insomnia from Class III to Class II, leaving CES devices for depression in the most highly regulated Class III category. New CES devices intended to treat anxiety or insomnia will require 510(k) clearance rather than the more stringent premarket review […]
Masimo’s improved pulse oximetry tech now available to all U.S. newborns
Masimo (NSDQ:MASI) has won FDA clearance for pulse oximetry sensors with improved oxygen saturation accuracy specifications for newborns over 3 kg in weight. Masimo touted significantly improved performance specifications for the RD SET sensors with Masimo Measure-through Motion and Low Perfusion SET pulse oximetry. The improved specs were already available for babies under 3 kg, so […]
FDA publishes final list of 510(k)-exempt devices
The FDA today published a list of Class I and Class II medical devices that it now considers exempt from premarket notification, in accordance with the 21st Century Cures Act. Sponsors of these devices will no longer have to apply for 510(k) clearance from the FDA. The agency said this action, published today in the Federal Register, […]
10 medical device industry stories you need to know
From leadership changes to tax repeal to robots — lots of robots — this was a busy year for the medical device industry. Here are 10 stories in the medtech space that especially caught the eye of MassDevice and Medical Design & Outsourcing editors and readers in 2019. Next>>
Augmedics launches its Xvision Spine AR nav system in U.S.
Augmedics announced today that it won FDA 510(k) clearance for and initiated the U.S. launch of its Xvision Spine augmented reality guidance system to be used in surgery. The company is touting Xvision Spine as the first AR guidance system to be used in surgery. The system is designed to allow surgeons to visualize the […]
Life Spine wins FDA nod for titanium spine fusion spacer system
Life Spine announced today that it won FDA 510(k) clearance for its titanium stand-alone anterior lumbar interbody fusion (ALIF) spacer system. The Huntley, Ill.–based company’s titanium stand-alone ALIF system is designed to approach the spine from the front of the body and remove disc or bone material from in between two adjacent lumbar vertebrae. Life […]
Bayer wins FDA clearance for expanded CT injection system
Bayer received FDA 510(k) clearance for expanded use of its Medrad Stellant Flex CT injection system with Certegra Workstation. The system is cleared for use in contrast-enhanced mammography (CEM), which can allow for better visualization fo abnormalities in breast tissue that may not be visible in standard mammography. “This FDA clearance underscores Bayer’s continued commitment […]
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