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 […]
510(k)
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 […]
BD wins 510(k) for intestinal bacteria diagnostic
Becton Dickinson (NYSE:BDX) said today that it won 510(k) clearance from the FDA for its molecular test that detects harmful intestinal bacteria causing infectious diarrhea. With the approval of its BD Max extended enteric bacteria panel, the company said the majority of pathogens causing acute gastroenteritis can be detected on its automated BD Max molecular […]
Masimo wins FDA nod for pediatric O3 regional oximetry indication
Masimo (NSDQ:MASI) said today it won FDA 510(k) clearance for a pediatric indication for O3 regional oximetry with its O3 pediatric sensor. With the extended indication, the Irvine, Calif.-based said that O3 regional oximetry monitoring will be available for pediatric patients which weigh more than 11lbs and less than 88lbs. The technology works by using near-infared spectroscopy […]
Intuitive Surgical wins FDA nod for daVinci X platform
Intuitive Surgical (NSDQ:ISRG) said today it won FDA 510(k) clearance for its new da Vinci X robotic surgical system, with a planned release of the platform later this year. The newly cleared da Vinci X system offers access to multiple robotic-assisted surgical technologies at a lower price than previous models, the Sunnyvale, Calif.-based company said. The […]
FDA clears Ra Medical’s Dabra arteriosclerosis laser
Medical excimer laser developer Ra Medical said it won FDA 510(k) clearance for its Dabra system designed to treat patients with peripheral artery disease. The Carlsbad, Calif.-based company said that the system is designed to destroy arteriosclerotic blockages through the use of radiation ablation, touting the device and associated procedures as cost and time saving. “Dabra’s pivotal […]