French ophthalmic device company Quantel Medical has gained U.S. FDA 510(k) clearance for its Optimis Fusion™ integrated laser platform.
Approval/Clearance
FDA Clears Dallen’s Disposable Compressyn™ Staple Delivery System for Small Bone Fixation
Dallen Medical has gained FDA 510(k) clearance for its Disposable Compressyn™ Staple Delivery System for Small Bone Fixation
FDA Clears Surgical Theater’s Surgical Navigation Advanced Platform
Augmented reality becomes a reality with the U.S. FDA clearance of Surgical Theater’s Surgical Navigation Advanced Platform (SNAP).
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
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.
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.
UK’s NICE Says MAGEC Scoliosis Device Better for Patient and Cheaper
Using a device that can be adjusted non-surgically to straighten scoliosis in kids means they can avoid repeated surgery and associated complications. Better for patients and it saves money, says UK’s NICE healthcare watchdog.
TAVI Pendulum Swings Back Edwards Way as Sapien XT Gets FDA Approval
After its main competitor gained approval last week, now Edwards has its own reason to celebrate as the next generation Sapien XT gets the FDA’s nod.
Strong Clinicals Behind FDA Approval of CoreValve® for High-risk Patients
Strong clinical results from Medtronic’s pivotal CoreValve High Risk study have persuaded the FDA to extend its approval to include patients at high risk for conventional surgery.