JustRight Surgical said today it won FDA 510(k) clearance for its JustRight 3mm pediatric surgery vessel sealing system. The Boulder, Colo.-based company touted the win as the 1st and only from the FDA for an electrosurgical device designed specifically for pediatric patients. “Pediatric surgeons have been requesting ‘right-sized’ surgical instruments and technologies for years. This […]
Surgical
Gecko Biomedical lands $1.6m loan for surgical adhesives
Gecko Biomedical said today that it landed a $1.6 million, interest-free loan from Bpifrance for the surgical adhesives it’s developing. Paris-based Gecko, which pulled down a $25 million Series A2 round in March, said the €1.4 million loan will go toward clinical trials in Europe aimed at winning CE Mark approval during the 1st half […]
Nico touts studies using BrainPath to treat hemorrhagic stroke
Nico Corp today released data from 2 recently published studies which utilized its BrainPath Approach to treat hemorrhagic stroke, touting a 95% clot reduction and no mortalities associated with the device. The BrainPath system uses a shunt and specially designed instrumentation to give surgeons access to the subcortical section of the brain. The device won 510(k) clearance from […]
HeartStitch touts 1st-in-human use in aortic valve surgery
Structural heart focused HeartStitch today touted the 1st-in-man use of the company’s HeartStitch technology in a transapical access and closure procedure at the National Cardiac Research Center in Astana, Kazakhstan. The 2 procedures were performed by device inventor, HeartStitch co-founder and CEO Dr. Anthony Nobles and CMO Dr. Michael Mullen, the company said. “This exciting technology […]
Arkis BioSciences lands $3m Series A for neurosurgery tools
Arkis BioSciences said today that it raised a $3.4 million Series A round for its line of neurosurgical tools, led by Innova Memphis. Angel Capital Group, the Lighthouse Fund and private investors also participated, Knoxville, Tenn.-based Arkis said. The proceeds are earmarked for further commercialization of its tunneling guidewire and Auto Shunt devices, plus the […]
FDA warns Medtronic’s Tyrx on anti-bacterial envelopes
The FDA sent a warning letter earlier this month to Medtronic (NYSE:MDT) subsidiary Tyrx over problems with its process validation and quality systems. The Tyrx envelopes are designed to elute a pair of anti-microbial drugs, minocycline and rifampin, for 7 days before dissolving over a period of roughly 9 weeks. They’re cleared for use with pacemakers, implantable cardioverter-defibrillators, cardiac […]
J&J’s Ethicon recalls Physiomesh flexible composite hernia mesh
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon last month recalled 1 of its surgical mesh products after studies showed higher revision rates after a type of minimally invasive hernia repair using its Physiomesh flexible composite mesh. In a May 25 letter to healthcare providers, Ethicon said it’s pulling the mesh after a review of unpublished data from […]
FDA OKs epilepsy trial for MDT’s Visualase MRI-guided laser
Medtronic (NYSE:MDT) said today that the FDA granted an investigational device exemption for a clinical trial of its Visualase ablation device in treating temporal lobe epilepsy. Fridley, Minn.-based Medtronic put $105 million on the table for Houston-based Visualase back in 2014, including $70 million in up-front cash and another $35 million in milestones. Medtronic had […]
Boston Scientific updates warnings for pelvic mesh products
Boston Scientific (NYSE:BSX) recently updated the directions for use and warnings for its pelvic mesh products, classifying the meshes as permanent implants and warning of complications related to removals. The Marlborough, Mass.-based company added new precautions to the directions for the meshes, warning that that “regardless of the route of delivery,” the meshes have been associated with […]
House bill would force docs to report medical device problems to FDA
A bill expected to be introduced today in the U.S. House of Representatives would require doctors to tell the FDA about problems they encounter with medical devices. The “Medical Device Guardian’s Act,” co-sponsored by Reps. Mike Fitzpatrick (R-Pa.) and Louise Slaughter (D-N.Y.), would amend the Food, Drug & Cosmetic Act “to require physicians and physician’s […]
Study: Insurance restrictions on lumbar fusions push procedure volumes down
An insurance policy limit on lumbar fusion procedures helped slash costs and medically unnecessary surgeries in North Carolina, and the approach could work nationally, according to new research published in the journal Spine. “The commercial insurance policy change had its intended effect of reducing fusion operations for indications with less evidence of effectiveness, without changing […]