Endoscopic device company Apollo Endosurgery, Inc., has announced that its OverStitch™ Endoscopic Suturing System has gained European CE Mark approval. The company plans to immediately launch the system to select centers in several European countries.
General Surgery
New FDA 510(k) Clearance For Tenex Health’s TX1 Tissue Removal System
Tenex Health’s TX1 is a clever ultrasonic device can cut and debride damaged tendon without affecting the surrounding healthy tissue. Now FDA has expanded its indications with a new 510(k) clearance that enables the company to press on with its pipeline of applications.
FDA 510(K) Clearance for Ethicon Endo’s ENSEAL® G2 Cordless
Ethicon Endo-Surgery, Inc. has announced the 510(k) clearance from the U.S. FDA for its ENSEAL® G2 Cordless Tissue Sealer Device. Already previously approved in a variety of iterations, the new cordless design is clearly pitched at procedures where speed and range of motion may be critical.
European Clinical Trial Of New Bowel Sealant To Commence
In short Surgical adhesive and sealant company, Cohera Medical, Inc.® , has announced that it has received approval to begin … continue reading “European Clinical Trial Of New Bowel Sealant To Commence”
RTI Biologics® Receives 510(k) Clearance for Porcine Dermis Implant
In short RTI Biologics Inc., is a long standing provider of orthopedic and other biologic implants. The company has now … continue reading “RTI Biologics® Receives 510(k) Clearance for Porcine Dermis Implant”
EndoBarrier® Therapy Launched In Israel
Israeli medtech outfit GI Dynamics, Inc. has launched its EndoBarrier® in its home market. The company has announced that The Sheba Medical Center (Tel Hashomer) at Ramat-Gan, Israel, is the first to offer the therapy, a non-surgical, non-pharmaceutical treatment for type 2 diabetes and/or obesity.
FDA Class I Recall For Lumenis VersaCut Tissue Morcellator
Israeli device company Lumenis Limited is recalling certain models of VersaCut Morcellator devices because of the potential for air embolisms to occur if the aspiration tubing is hooked up backwards to the aspiration control box housing.
FDA Nod For Ethicon Endo’s ENSEAL® G2 Articulating Tissue Sealer
Ethicon Endo-Surgery says its ENSEAL® advanced bipolar devices are strong on sealing, yet gentle on tissue. And now with a new Articulating iteration these benefits can be exploited in the most difficult-to-access anatomies.
U.S. EndoBarrier® Clinical Trial Started
GI Dynamics, Inc. has announced that it has initiated its U.S. multicentre pivotal clinical trial of EndoBarrier®, the ENDO Trial, for the treatment of patients who have uncontrolled type 2 diabetes and are obese.
EndoBarrier® Works. New Collaborations Might Explain How.
GI Dynamics has announced that it has entered into separate research collaborations with GlaxoSmithKline and Medtronic in an effort to understanding how EndoBarrier® works in relation to diabetes.
First Patient For Boston Scientific’s Removable WallFlex® Biliary RX Fully Covered Stent
The first patient has been enrolled in a Boston Scientific Corporation (NYSE: BSX) study comparing the WallFlex® Biliary RX Fully Covered self-expanding metal stent (SEMS) to plastic stents for the treatment of benign bile duct strictures caused by chronic pancreatitis.
Surgical Innovations Shows Value Of University Partnership
UK MIS device company Surgical Innovations has successfully completed two Knowledge Transfer Partnership collaborations with both the University of Leeds and the University of Bradford, which the company says will help them to optimise their range of laparoscopic surgery devices.
Integra’s UK Facility Gets An FDA Wrist Slap Letter About “Quality Systems Issues”
We don’t know what it’s about, but it’s obviously material enough to warrant Integra going to press with the news that it has received a warning letter from the FDA following the agency’s audit of its UK facility earlier this year.
HealthTronics Launches New Line Of Slimline Cryoprobes For Use With Its Endocare® Cryocare® Systems
HealthTronics’ new slimline cryoprobes include an ergonomic handle to ease insertion and a slim profile for a better fit in tight areas.
FDA 510(k) Clearance For Thermedical™ RF Ablation System For Larger Tissue Volumes
Thermedical™, a medical equipment company developing new tissue-ablation therapies, has received U.S. FDA clearance to market its innovative technology for the coagulation and ablation of soft tissue during percutaneous, laparoscopic and intraoperative surgical procedures.
Surgical Innovations Sends First PretzelFlex® Order To CareFusion
UK MIS company Surgical Innovations has kicked off its US commercialisation activities with the shipment of a first order of its Pretzelflex® retractor to exclusive distributor CareFusion.