Augmented reality becomes a reality with the U.S. FDA clearance of Surgical Theater’s Surgical Navigation Advanced Platform (SNAP).
Products
FDA Clears Itamar Medical’s WatchPAT™ Unified Sleep Apnea Diagnostic Device
Israeli device company Itamar Medical has reported the U.S. FDA clearance of its new and upgraded WatchPAT™ Unified sleep apnea diagnostic device.
Ophthalmics: CE Mark for STAAR Surgical’s Visian® ICL™ Preloaded System
IOL and Ophthalmic device company STAAR Surgical has received CE Mark approval for its new Visian® ICL™ Preloaded System.
FDA Clears Edwards Lifesciences’ Advanced Noninvasive Hemodynamic Monitoring System
The U.S. FDA has cleared Edwards’ ClearSight system, a noninvasive monitor that provides clinicians access to valuable blood volume and blood flow information for patients at moderate or high risk of post-surgical complications
Zimmer Says New Virage® OCT will Change Perspective on Posterior Spinal Fixation
Zimmer Spine has announced the U.S. market launch of the Virage OCT Spinal Fixation System, an Occipital-Cervico-Thoracic spinal fixation system that it says will change surgeons’ perspective on posterior fixation.
FDA 510(k) Approval for Encision’s AEM EndoShield™ Burn Protection System
Encision Inc., a medical device company that exists to prevent dangerous stray electrosurgical burns in minimally invasive surgery, has received FDA 510(k) clearance for its AEM Endoshield™ Burn Protection System.
FDA 510(k) Clearance for Fujifilm’s Aspire Cristalle Breast Imaging Solution
Fujifilm Medical Systems has gained U.S. FDA 510(k) clearance for its Aspire Cristalle which it says “resets the bar in digital mammography.”
Now da Vinci Xi Surgical System gets CE Mark
Intuitive Surgical, Inc. has gained CE Mark approval for its da Vinci Xi Surgical System, following its U.S. FDA clearance back in April.
Newly Approved Device Targets GunShot Wound Hemostasis
A newly FDA approved syringe-based dispenser of absorbent sponges aims to stop the flow of blood from gunshot wounds.
CE Mark for Abbott’s TECNIS® Symfony Extended Range of Vision IOL
Abbott has gained CE mark approval for its TECNIS® Symfony Extended Range of Vision intraocular lens (IOL) for the treatment of cataract patients who may also have a diminished ability to focus on near objects (presbyopia).
FDA 510(k) Clearance for Devon Medical’s extriCARE® 3600 High-Flow NPWT System
The U.S. FDA has granted 510(k) clearance for Devon Medical Products to market its extriCARE® 3600 Negative Pressure Wound Therapy (NPWT) pump and foam dressing kit.
PixArt Introduces Wearable Heart Rate Monitor
Human-machine interface specialist PixArt Imaging Inc., has announced the release of its Heart Rate Monitor sensor for smart phones and wearable device platforms.
InVivo Ditches Drug Delivery Gel and 28% of Staff
Getting a new technology to market is an expensive undertaking, and often painful too as InVivo Therapeutics is finding out as it ditches an R&D project and 28% of its staff while its Neuro-Spinal Scaffolds go through a lengthy regulatory approval process.
Surface Topography Influences Spinal Implant Performance Claims Maker
Spinal interbody fusion implant company Titan Spine has announced that it has expanded use of its “osteogenically favourable” Endoskeleton® line of devices to the United Kingdom and Spain.
MGuard™Prime EPS Back on EU Market After Mods
Inspire MD has modified its MGuard Prime Embolic Protection Stent in order to address dislodgement issues. The EU authorities have given them the nod to return it to the market.
CareFusion Builds on Micro-Laparoscopic Offering with New 2.7mm Instrument Range
CareFusion says its new line of Micro-Laparoscopic instruments means it is on trend with miniaturized procedures.