Stryker is launching a voluntary field action on certain units of its Lifepak 15 monitor/defibrillators. The company is notifying customers of an issue that could cause the devices to fail to deliver a defibrillation shock after pressing the “shock” button on the keypad. The problem stems from oxidation that forms over time within the button. […]
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 […]
Laborie Medical Technologies buys Clinical Innovations
Laborie Medical Technologies has purchased Clinical Innovations in a deal worth $525 million. The deal is expected to close in early 2020. Through the deal, Clinical Innovations will continue to help mothers and babies through its labor, delivery and neonatal intensive care specialties. “This is a promising deal that will add scale to the overall […]
CryoLife, Misonix sign distribution deal for NeoPatch
CryoLife this week said it signed a distribution agreement with Misonix where Misonix will have exclusive commercialization rights of NeoPatch. The NeoPatch, made by CryoLife, is a dehydrated and terminally sterilized chorioamniotic allograft that is made from human placental membrane. It is designed to treat a wide range of indications outside of cardiac and vascular […]
Medtronic wins FDA clearance for brain surgery guidance system
Medtronic (NYSE:MDT) today said it won FDA clearance for its cranial robotic platform the Stealth Autoguide system. The Stealth Autoguide Platform is a robotic guidance system that is designed for spatial positioning and orientation of instrument holders and tool guides that are used in neurosurgical procedures. “Medtronic continues to deliver on its commitment of developing innovative […]
Cook Medical issues Class I recall of CrossCath Support Catheters
Cook Medical is recalling its CrossCath Support catheters due to potential marker bands dislodging or buckling in a Class I recall. Cook Medical said an error occurred during manufacturing that could cause radiopaque marker bands to be too loose on some CXC3.0 CrossCath Support Catheters and could be too tight on certain CXC3.4 CrossCath Support […]
Baebies wins CE Mark for near-patient testing platform
Baebies today said it received CE Mark for its Finder near-patient testing platform. Finder is an in vitro diagnostic device (IVD) that features an instrument and cartridge that can test for Glucose-6-Phosphate Dehydrogenase from low blood volume, or a single drop of whole blood. It can provide results within 15 minutes after sample introduction. “The […]
Prasco launches generic NuvaRing
Prasco this week said it launched its authorized generic NuvaRing. The generic etonogestrel/ethinyl vaginal ring is a small, flexible vaginal ring that is used by women as a form of birth control. The NuvaRing releases a continuous low dose of hormones for three weeks at a time. Get the full story on our sister site, Drug […]
FDA clears etectRx ingestible event marker
EtectRx this week announced that the FDA cleared its ID-Cap System ingestible event marker. The ID-Cap System is an ingestible event marker that transmits digital messages from within the body to an external receiver. EtectRx’s ID-Cap System features the ID-Capsule, ID-Tag, ID-Cap Reader and related software. It gives real-time dose-level ingestion event verification and the […]
Elekta wins FDA approval for diffusion-weighted images
Elekta (STO:EKTA B) today announced that it received FDA 510(k) premarket notification for its diffusion-weighted MR images from the Elekta Unity. The clearance allows the images to be interpreted by a trained physician. With the new FDA clearance, the system can be used for the biologic assessment of tumor response during therapy. Diffusion-weighted MR images (DWI) […]
FDA clears first single-use duodenoscope from Boston Sci
The FDA said it cleared the first fully disposable duodenoscope, made by Boston Scientific. The EXALT Model D Single-Use Duodenoscope is designed for use in endoscopic retrograde cholangiopancreatography procedures. It is the first single-use duodenoscope on the market and was granted Breakthrough Device Designation. “The availability of a fully disposable duodenoscope represents another major step […]