French surgical robotics firm Medtech Innovative Surgical Technology said today it won FDA 510(k) clearance for its ROSA spine robot. The robot is designed to be used during minimally invasive spinal surgeries, though the ROSA platform is shared with its brain system, designed for brain surgery procedures. “We are thrilled to have FDA approval for […]
Surgical
ConMed closes $265m SurgiQuest buy
ConMed (NSDQ:CNMD) said today that it closed the acquisition of SurgiQuest, which makes the AirSeal device for use in minimally invasive abdominal surgeries. The $265 million deal, announced just a week after Milford, Conn.-based SurgiQuest filed for a $75 million initial public offering last November, was funded with a $175 million term loan and a $525 million credit revolver. Utica, N.Y.-based […]
Checkpoint Surgical closes $7.5m funding round
Neuroprotective device maker Checkpoint Surgical said it closed its 1st round of institutional financing, bringing in $7.5 million for its Checkpoint handheld nerve monitor. The Checkpoint Stimulator/Locater stimulates motor nerves so surgeons can avoid damaging them during surgery. The device also helps physicians gauge nerve and muscle health. The device has been on the U.S. market since […]
AtriCure launches study of combined surgical, catheter afib ablations
AtriCure (NSDQ:ATRC) said today that it launched a clinical trial comparing a combined ablation approach with catheter ablation in patients with persistent atrial fibrillation. The 1st subject in the more-than-200-patient CEASE AF study was treated by co-principal investigator Dr. Nicolas Doll of the Sana Heart Center in Stuttgart, Germany, West Chester, Ohio-based AtriCure said. The trial is designed to compare […]
Arch Therapeutics wins EU nod for AC5 hemostat trial
Arch Therapeutics (OTC:ARTH) said it won approval for a European safety-and-efficacy study of its AC5 surgical hemostat in bleeding wounds incurred during dermatology procedures. Framingham, Mass.-based Arch said the endpoints for the single-blinded study of up to 50 patients include time to hemostasis and product-related adverse effects at 30 days. One arm of the trial will include patients taking blood […]
FDA: InVivo spinal scaffold trial cleared from pilot to pivotal
InVivo Therapeutics (NSDQ:NVIV) said today it won conditional approval to convert its ongoing Neuro-Spinal scaffold pilot study to a pivotal probable benefit study, allowing the company a faster path to FDA approval. The conditional approval is based upon a change to the informed consent form the company already submitted to the FDA, and full approval is […]
Supreme Court denies Covidien in $177m surgical shears spat with J&J’s Ethicon
The long-running patent infringement war between Medtronic’s (NYSE:MDT) Covidien subsidiary and Johnson & Johnson‘s (NYSE:JNJ) Ethicon Endo-Surgery unit over surgical shears appears to be over, after the U.S. Supreme Court today declined to review the case. Covidien in August asked the Supremes to hear its appeal of a December 2014 decision by the U.S. Court of Appeals for the Federal Circuit, which […]
CryoLife settles PerClot beef with Bard’s Medafor
CryoLife (NYSE:CRY) said today that is agreed to settle a patent infringement battle with C.R. Bard (NYSE:BCR) subsidiary Medafor over CryoLife’s PerClot hemostasis agent. Atlanta-based CryoLife last year asked Judge Susan Robinson of the U.S. District Court for Delaware to rule that the PerClot product does not infringe a patent Medafor’s competing Arista product. Medafor filed a […]
ConMed to drop $265m on SurgiQuest
ConMed (NSDQ:CNMD) said it agreed to pay $265 million to acquire SurgiQuest, which just last week filed for an initial public offering. Milford, Conn.-based SurgiQuest makes the AirSeal device for use in minimally invasive abdominal surgeries. AirSeal is designed to insufflate the rectum and provide continuous smoke evacuation. ConMed, which is based in Utica, N.Y., said […]
Mauna Kea looks to Medtronic, Stryker, others for help in commercializing Cellvizio
Mauna Kea (ENT:MKEA) founder & CEO Sacha Loiseau is looking to some of the biggest names in medtech for help in commercializing its Cellvizio device in the U.S. after winning 510(k) clearance from the FDA last month. Paris-based Mauna Kea could ink a deal by the end of the year that would allow it to speed Cellvizio to market […]
SurgiQuest files for $75m IPO
SurgiQuest this week registered for an initial public offering estimated at $75 million. Milford, Conn.-based SurgiQuest makes the AirSeal device for use in minimally invasive abdominal surgeries. AirSeal is designed to insufflate the rectum and provide continuous smoke evacuation. “We believe our AirSeal technology represents the first major innovation in minimally invasive surgical access since the introduction […]