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 […]
510(k)
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 […]
Soterix Medical wins FDA 510(k) for IontoDC
Soterix Medical said today it won FDA 510(k) clearance for its IontoDC device designed to use direct current to introduce ions of soluble salts and other drugs into the body. The New York-based company said that the newly-cleared IontoDC device provides 10, 20, 30 or 40 minutes of direct current at intensities varying between 1 and […]
7 medtech stories we missed this week: May 19, 2017
From FDA clearances to touting study data, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. XpandOrtho wins FDA 510(k) clearance XpandOrtho announced in a May 17 press release that it has received FDA 510(k) clearance for its electronic soft tissue balancing instrument for total knee replacement surgery. […]
Myoscience wins FDA nod for Iovera knee osteoarthritis device
Myoscience said today it won FDA 510(k) clearance for its Iovera device designed to relieve pain and symptoms associated with knee osteoarthritis. The Fremont, Calif.-based company’s Iovera technology is a non-opioid and non-systemic treatment designed to block pain signals from the peripheral nerves. Myoscience said the Iovera treatment uses the body’s natural response to cold […]
Smart Meter wins FDA nod, CE Mark for iGlucose monitoring system
Diabetes-focused medical device developer Smart Meter said today it won FDA 510(k) clearance and CE Mark approval in the European Union for its iGlucose blood glucose monitoring system. The New York-based company’s iGlucose system is a subscription-free glucose meter and diabetes health managements system which automatically transmits data to a cloud-based personalized web portal. The system […]
NxStage wins FDA nod for next-gen System One hemodialysis system
NxStage Medical (NSDQ:NXTM) said today it won FDA 510(k) clearance for its next generation System One hemodialysis system. The newly cleared system includes a new touchscreen user interface and integrated blood pressure monitor designed to enhance ease of use for home hemodialysis patients, the Lawrence, Mass.-based company said. “Early customer and patient feedback in the UK on our next […]
CurveBeam wins FDA 510(k) for InReach extremity cone beam CT
Medical imaging device developer CurveBeam said today it won FDA 510(k) clearance for the InReach cone beam CT imaging system. The Warrington, Penn.-based company’s InReach is an ultra-compact CT scanner designed to provide high-contrast 3D datasets of bony anatomy. The system is designed primarily for the hand, wrist, elbow and lower extremities in non-weight bearing […]
Crospon wins FDA 510(k) for next-gen Endoflip system
Endoscopic diagnostic company Crospon said today it won FDA 510(k) clearance for its next-gen Endoflip system with Flip topography module, designed to allow clinicians to assess patient motility disorders during endoscopy. The newly cleared Endoflip 2.0 system includes imaging software that displays esophageal contractility patterns in real time on a touch screen display, the Ireland-based […]