CHF Solutions (NSDQ:CHFS) said yesterday it plans to expand into the post-cardiovascular surgery market, specifically with products for patients who need treatment for fluid overload and have failed diuretic therapy. The Eden Prairie, Minn.-based company said that it sees the expansion into the post CV surgical market as a “natural next step” in its commercial expansion, […]
Surgical
Xact Robotics wins CE Mark for robotic nav & steering system, raises $5m in Series C
Xact Robotics said today it won CE Mark approval in the European Union for its robotics navigation and steering system designed for image-guided percutaneous procedures, and said it raised $5 million in a Series C round of financing. The Caesarea, Israel-based company said its Xact robotics system was cleared for use in planning and accessing targets […]
FDA clears Surgical Innovation’s DuraSorb bioresorbable mesh
Medical device start-up Surgical Innovation Assets said yesterday it won FDA 510(k) clearance for its DuraSorb monofilament mesh, designed for reconstructive and cosmetic surgery. The newly cleared DuraSorb mesh is the first from a line of advanced bioresorbable technologies, the Chicago-based company said. The DuraSorb is intended to integrate into the patient’s tissue to provide […]
Intuitive Surgical seeks FDA approval for lung biopsy robotic platform tools
Intuitive Surgical (NSDQ:ISRG) said yesterday it submitted a premarket notification application to the FDA seeking clearance for its new flexible, robotic-assisted catheter-based platform intended for use in the lungs. The new platform is designed for navigation through very small lung airways to reach peripheral nodules for biopsies, the Sunnyvale, Calif.-based company said in a press release. […]
TransEnterix submits FDA clearance bid for Senhance ultrasonic instrumentation
TransEnterix (NYSE:TRXC) said today it filed an FDA 510(k) submission for its Senhance Ultrasonic instrument system, designed to operate with its Senhance robotic platform. The Research Triangle Park, N.C.-based company said that the approval would allow the system to utilize ultrasonic devices designed to deliver controlled energy to ligate and divide tissue and minimize thermal injury […]
Longeviti’s ClearFit gives neurosurgeons a view inside the head
Longeviti Neuro Solutions has launched its novel ClearFit implant to correct and/or restore bony voids or defects of the cranium. This clear, patient-specific implant enables neurosurgeons to see neuroanatomy and critical functional components beneath the ClearFit once it is implanted. “The real advantage to this system is the ability to see what’s underneath the […]
CMR Surgical unveils Versius robotic surgical platform
CMR Surgical today unveiled its portable Versius robotic surgical platform, designed for use in minimal-access procedures. The U.K.-based company said that the Versius robotic platform’s design is inspired by the human arm, and is intended to be affordable and transportable due to its small size and modular design. CMR Surgical said that it hopes the […]
Bovie Medical closes $97m sale of core electro-cautery biz to Symmetry Surgical
Bovie Medical (NYSE:BVX) said today it closed the $97 million sale of its core electro-cautery business, including the Bovie brand, to Symmetry Surgical. The all-cash sale comes as Clearwater, Fla.-based Bovie looks to pivot toward the cosmetic surgery market, and includes transition services, patent licensing, disposables supply and generator manufacturing agreements. The deal also includes terms […]
Ceterix Ortho wins expanded FDA nod for NovoStitch Pro
Ceterix Orthopaedics said yesterday it won expanded FDA 510(k) clearance for its NovoStitch Pro meniscal repair system, clearing the system for use with a size 0 suture cartridge. The Fremont, Calif.-based company’s NovoStitch Pro system is designed to allow surgeons to place stitches arthroscopically in tight joint compartments to treat meniscal tears that had previously […]
Gore tests stent graft for deadly heart condition
W. L. Gore & Associates announced the first implant of its ascending stent graft, an investigational device and the only endovascular stent graft specifically designed to treat Type A dissections of the ascending aorta. The surgery was part of Gore’s ARISE study, the first multicenter, early feasibility study approved by the FDA to investigate how […]
Invuity launches PhotonGuide Adapt vaginal surgical illuminator and retractor system
Invuity (NSDQ:IVTY) said yesterday it launched the PhotonGuide Adapt system featuring a flexible illuminator and retractors for vaginal surgical procedures. The devices are designed for use in procedures including pelvic organ prolapse repairs and vaginal hysterectomies, the San Francisco-based company said. The PhotonGuide Adept’s waveguide is designed to conform to different sizes and shapes of retractors […]