Treatment decisions or sleep apnea sufferers need no longer be quite so hit and miss as FDA clears Somnomed’s MATRx device for predicting outcome of Oral Appliance Therapy
FDA Approval
FDA Clears Soma’s AxoTrack™ Needle Visualisation System
Soma’s Axotrack looks like a compelling, ultrasound-guided solution to the challenge of accurate needle placement. The company’s two newly FDA cleared applications suggest the agency agrees.
Now LINX Reflux Management System Gains FDA Clearance
Torax’s LINX system of magnets acting to support the oesophageal sphincter gains FDA clearance.
Pretzelflex™ Laparoscopic Retractor Gains FDA Clearance
UK medical device company Surgical Innovations has gained FDA clearance for its Pretzelflex™ laparoscopic retractor.
Post-Operative Antiemetic Device Wins FDA 510(k) Clearance
FDA approval for non-invasive pressure device prevents Post-op nausea. Acupuncture without needles.
Landmark FDA Clearance For GINTUIT™ Oral Soft Tissue Regeneration Sheet
FDA Approval for Organogenesis Inc’s Gintuit™ marks first cell-based product for use in dental market.
FDA Clearance For Covidien’s Everflex™ Long Peripheral Stent
Covidien’s past acquisitions keep coming up trumps. EV3’s Everflex™ device has now been cleared for US marketing by FDA, bringing a useful new long stent option to peripheral vascular surgeons.
Abbott’s Absolute Pro® Vascular Stent Receives FDA Approval For Iliac Artery Disease
Abbott’s Absolute Pro Stent for Iliac Disease has gained FDA clearance. The product is designed for precise stent placement and Optimal Flexibility to Conform to Challenging Lesions.
K2M’s SANTORINI™ Corpectomy Cage Systems Gain FDA Clearance
K2M Inc has announced the FDA 510(k) clearance of its Santorini Corpectomy Cage System, adding to the company’s portfolio of offerings for treatment of complex spine disorders.
FDA Clears Covidien’s Solitaire™ FR Revascularisation Device
With a certain inevitability following rave reviews in its pivotal clinical study, Covidien’s revascularisation device for removing clots from occluded vessels in stroke patients has now gained FDA 510(k) clearance.
FDA Clears Resolute Integrity™ DES For Coronary Artery Disease Including Diabetes Indication
Medtronic Inc’s Resolute Integrity™ Drug-Eluting Stent for treating coronary artery disease has been approved by the FDA, after studies showed consistent clinical performance among a wide range of patients, including individuals with diabetes.
FDA Clears Two New Clavicle Repair Technologies
Suspension Orthopaedics has gained FDA clearance for some interesting clavicle plates addressing specific problems associated with clavicular fracture.
No Long Guidewire, Less Bruising: FDA Clearance for AngioDynamics NeverTouch Direct™Procedure Kit For Use With the VenaCure EVLT® System
NeverTouch Direct Kit for treatment of Varicose Veins With Fewer Procedure Steps, has gained FDA clearance.
Implantable, Programmable Drug Pump Gains FDA Clearance
The Prometra implantable, programmable pump from Medasys, represents the first non-peristaltic drug-infusion device to gain PMA approval. The product is already CE marked and available in selected European countries, with full EU roll-out expected in the next few months.
FDA Approves Therapy Cool Path Duo™ Ablation Catheter, Safire BLU Duo™ Ablation Catheter, and Cardiac Ablation Generator.
FDA approves cardiac ablation products from St Jude.
510(k) For Bovie’s Patented J-Plasma™ Technology
Bovie Medical Corporation, has announced that it has received 510k clearance from the Food and Drug Administration (FDA) to market its J-Plasma™ handpiece with retractable cutting feature for soft tissue coagulation during surgery.