Fujifilm Medical Systems has gained U.S. FDA 510(k) clearance for its Aspire Cristalle which it says “resets the bar in digital mammography.”
Regulatory
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.
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.
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.
VBLOC® Vagal Blocking Obesity Therapy Would be First for Ten Years… if Approved
If FDA supports its advisory panel’s less than unanimous endorsement, EnteroMedics’ VBLOC will be the first device to be approved for Obesity treatment in ten years.
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.
Race is on as FDA Panel Vote Leaves C.R.Bard on Verge of First Drug Coated Balloon Approval
Lutonix® DCB is one step closer to becoming the first FDA-approved drug coated balloon for the treatment of patients with femoropopliteal occlusive disease following the FDA Circulatory devices panel vote.
Medtronic’s Drug Coated Balloon Aims to be U.S. First for Peripheral Artery Disease
Medtronic has submitted the final module of its PMA application. A successful outcome would make the IN.PACT Admiral drug-coated balloon the first of its kind approved for Peripheral Artery Disease.
SpineGuard® Adds Bevel-Cannulated PediGuard®
MIS spine specialist SpineGuard® has added a Bevel-Cannulated iteration to its clever PediGuard® guided pedicle screw placement range.
FDA Approval for Covidien’s Neurovascular Micro Catheter
Covidien’s Apollo™ Onyx™ delivery Micro Catheter with Detachable Tip has gained FDA approval and will enhances the company’s Onyx™ Liquid Embolic System.
FDA Clears Eeva™ System to Assess Embryo Development Potential
The Eeva System enables IVF clinicians the first prognostic, non-invasive test that provides objective information regarding embryo development potential.