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.
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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.
Wright Medical Group Launches INFINITY® Total Ankle System
Wright Medical’s newly launched system combines a low-profile implant design and seamless integration with PROPHECY® Pre-Operative Navigation Alignment Guides.
EU Launch for Smiths Medical Tracheostomy Tubes for Neonates and Pediatric Patients
Company introduces standard version of Bivona® FlexTend™ TTS™ cuffed tracheostomy tubes for children in healthcare and homecare settings
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.
Acumed® Launches Total Wrist Fusion Plating System for Post-Traumatic Arthritis
Acumed’s new Total Wrist Fusion Plating System for Post-Traumatic Arthritis aims to reduce the risk of soft tissue irritation associated with traditional plates.
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.
FDA IDE for PulseRider® Intracranial Bifurcation Aneurysm Device
Pulsar Vascular receives FDA IDE approval for the PulseRider® Aneurysm Neck reconstruction device for the treatment of intracranial bifurcation aneurysms
Steris Isomedix Still on FDA Naughty Step
If there was such a thing as a Naughty Step at FDA HQ, Steris Isomedix would probably be on it as it fails to close out numerous warnings to the agency’s satisfaction.
HeartWare Sanguine on FDA Warning Letter Resolution
HeartWare International tells us it will respond to the FDA over its warning letter, and has resolution of the matters raised well in hand.
Toshiba’s Patient-Friendly Claims for New PET/CT System
Toshiba says its new imaging system offers a package of features that make it the most patient friendly PET/CT system on the market.