ClearFlow said today it won FDA 510(k) clearance for its FlowGlide active clearance technology system designed to prevent or reduce clot occlusions during chest drains. The Anaheim, Calif.-based company said that the device is designed to prevent retained blood syndrome, which can be detrimental to outcomes after cardiothoracic surgery and may require late interventions. “ClearFlow is […]
510(k)
Additive Ortho wins FDA nod for 3D printed bunion correction system
Early-stage orthopedics company Additive Orthopaedics said today it won FDA 510(k) clearance for its 3D printed, minimally-invasive, intramedullary bunion correction system. The Little Silver, N.J.-based company said the clearance was its 4th which leveraged additive manufacturing and 6th complete product line, including its 3D printed core products, biologics and custom equipment. “This new 3D printed implant […]
FDA clears Conformis’ iTotal hip replacement
ConforMIS (NSDQ:CFMS) said today it won FDA 510(k) clearance for its primary iTotal Hip replacement system. The iTotal Hip system features the company’s iFit technology which uses single-use, custom 3D printed instruments and a limited amount of reusable instruments to deliver a customized hip replacement, the Billerica, Mass.-based company said. “Standard hip replacement surgery can be challenging, […]
Intuitive Surgical wins FDA nod for inguinal hernia repairs with da Vinci Xi
Update: Removed information claiming benefits of robotic hernia surgeries at request of Intuitive Surgical, which said that the data came from an inaccurate source and was not valid. Intuitive Surgical (NSDQ:ISRG) said today it won FDA clearance for inguinal hernia repairs with its da Vinci Xi robotic surgical system. Inguinal hernias occur when tissue presses through […]
BD wins FDA nod for customizable mini-laparoscopic instruments
Becton Dickinson & Co. (NYSE:BDX) said today it won FDA 510(k) clearance for its line of Snowden-Pencer 3mm laparoscopic customizable surgical instruments. The line of Snowden-Pencer instruments are designed for micro-laparoscopic surgery and are intended to function like 5mm instruments, the Franklin Lakes, N.J.-based company said. Jaw lengths on the devices are designed to mirror […]
Cleveland Clinic spinout Infuseon wins FDA nod for CNS drug delivery device
Cleveland Clinic spinout Infuseon Therapeutics said today that its novel central nervous system delivery device won 510(k) clearance from the FDA as a therapeutic delivery device. The company’s Cleveland Multiport Catheter, which won FDA clearance in March, was designed to effectively deliver therapeutics to the brain. Usually, the blood brain barrier prevents drugs delivered in […]
Milestone Scientific wins 510(k) clearance for epidural anesthesia system
Milestone Scientific (NYSE:MLSS) said today that its CompuFlo epidural computer-controlled anesthesia system won 510(k) clearance from the FDA. The Livingston, N.J.-based company’s CompuFlo Epidural instrument uses dynamic pressure sensing to help anesthesiologists correctly identify the epidural space and significantly reduce complications in real-time, according to Milestone. Get the full story at our sister site, Drug […]
7 medtech stories we missed this week: June 9, 2017
From 3M’s expanded 510(k) clearance for its Tegaderm dressing to Medtronic and Acacia burying the hatchet, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. InspireMD inks Taiwanese distro deal for CGuard InspireMD announced in a June 8 press release that it has signed a distribution deal with […]
FDA clears AngioDynamics Solero MW tissue ablation system
AngioDynamics (NSDQ:ANGO) said today it won FDA 510(k) clearance for its Solero microwave tissue ablation system, with indications for the ablation of soft tissue during open procedures. The company’s Solero MTA system features a Solero MW generator with a 2.45 GH operating frequency and specially designed Solero MW applicator. The generator can power up to 140 […]
Gore wins FDA nod for Synecor preperitonial hernia repair system
W.L. Gore & Associates said today it won FDA 510(k) clearance for its Synecor preperitoneal biomaterial hernia repair device, with plans to launch the device this week. The Synecor preperitoneal biomaterial is a hybrid biosynthetic hernia repair device designed for use in single-stage preperitoneal, onlay and retromuscular placements through open, laparoscopic and robotic procedures, the Flagstaff, […]
OrbusNeich wins FDA nod for Sapphire II Pro, NC Plus balloon dilation caths
OrbusNeich said today it won FDA 510(k) clearance for its Sapphire II Pro and Sapphire NC Plus balloon dilation catheters and launched the devices in the US. The Hong Kong-based company’s Sapphire II Pro features a sub-zero tapered tip and an ultra-low profile for entry through tight lesions, as well as a proprietary XR balloon for crossability […]