LifeBond said today that it won CE Mark approval in the European Union for its LifeSeal surgical sealant for gastrointestinal resection procedures, and got on the fast track with the FDA for the surgical sealant. LifeSeal is designed to minimize staple-line leakage during anastomosis or linear surgical repair of the GI tract, Caesarea, Israel-based LifeBond said. […]
Surgical
Intuitive Surgical cautions on cardiac cryoablation with non-da Vinci instruments
Intuitive Surgical (NSDQ:ISRG) today released a field safety notice it sent to da Vinci customers regarding the use of the da Vinci EndoWrist instruments with a cryoablation probe, warning of issues involving microscopic metallic particulate. The robotic surgery giant advised customers to not use any da vinci instruments other than the Cardiac Probe Grasper to manipulate […]
Verb Surgical CEO Heunnekens says company is focusing on “digital surgery”
Verily and Johnson & Johnson‘s (NYSE:JNJ) collaborative business Verb Surgical looks to set the stage for a new style of robotic surgery, called “digital surgery,” according to an interview with CEO Scott Huennekens. Verb Surgical aims to develop a comprehensive surgical platform that incorporates “leading edge” robotic capabilities and medical technology for use in the operating room, […]
Gauss Surgical raises $13m in Series B for blood loss app
Gauss Surgical said today it closed a $12.6 million Series B financing round to support its real-time surgical blood loss monitoring platform. The company said the addition brings the total funds raised up to $24.6 million. The round was led by Providence Health & Services investment arm Providence Ventures, with participation from Chicago-based Jump Capital and existing […]
Fortimedix seeks FDA clearance for single-port surgery device
Netherlands-based medical device company Fortimedix Surgical said today it submitted an application for FDA 510(k) clearance for its FMX314 single-port surgery device. The company said its FMX314 is the “world’s 1st” single-port surgery solution compatible with standard 15mm laproscopic trocar. The device “closely mimicks” conventional multi-port laparoscopy to allow surgeons to comfortably perform procedural steps, […]
Baxter wins expanded EU indication for Hemopatch
Baxter (NYSE:BAX) said today it won CE Mark approval in the European Union for an expanded indication for its ready-to-use surgical Hemopatch. The Deerfield, Ill.-based company’s Hemopatch is now cleared for use in closing dural defects including excision, retraction or shrinkage of the dura mater following traumatic injury. The patch is also cleared as a hemostatic […]
Gore launches new type of study for Synecor hernia biomaterial
W.L. Gore & Associates said today it is launching a clinical quality improvement project to study its Synecor biomaterial designed for open, laparoscopic and robotic single-stage hernia repairs. The Synecor biomaterial is comprised of dense monofilament polytetrafluoroethylene macroporous knit to provide strength and reduce bacteria growth, Gore’s Bio-A Web tissue scaffold and a non-porous PGA/TMC […]
Intersect ENT wins expanded FDA approval for Propel Mini
Intersect ENT (NSDQ:XENT) said today it won FDA premarket approval for an expanded indication for its Propel mini steroid releasing sinus implant designed to treat patients undergoing frontal sinus surgery. The expanded indication from the Menlo Park, Calif.-based company will allow the company to market the placement of the Propel mini in the frontal sinuses […]
Stryker launches $5m SurgiCount liability plan for retained sponges
Stryker (NYSE:SYK) said today it is launching the SurgiCount Promise risk-sharing program, offering up to $5 million in product-liability costs to hospitals which use its SurgiCount safety-sponge system. The system is designed to eliminate retained sponges, which can cause severe injuries in patients and cost the healthcare system $2.4 billion on average every year, according […]
Medtronic to shift product lines from Colorado plant
Medtronic (NYSE:MDT) is planning to move a pair of product lines from a plant in Colorado to other facilities, a spokesman told MassDevice.com today. Fridley, Minn.-based Medtronic acquired the lines when it paid $50 billion for Covidien in January 2015. Spokesman John Jordan told us that the plant in Boulder, Colo., makes surgical energy return pads and electro-surgical pencils. […]
Johnson & Johnson looks to settle morcellator lawsuits
Johnson & Johnson(NYSE:JNJ) is reportedly looking to settle 100s of product liability and wrongful death lawsuits brought over its now-recalled laparoscopic power morcellators used during surgeries to remove ostensibly benign uterine tumors. The morcellators, which use a cutting tip to shred and remove uterine tissue, have been implicated in the spread of a lethal cancer that […]