SuperSonic Imagine said today it won FDA 510(k) clearance and CE Mark approval in the European Union for its next-gen Aixplorer Mach 30 ultrasound system. The France-based company touted that the newly cleared system features its UltraFast imaging and enhanced performance over previous models of the device. The Aixplorer features the company’s SonicPad touchpad interface […]
510(k)
Zebra Medical Vision wins FDA nod for Coronary Calcium Scoring algorithm
Israeli machine-learning radiology firm Zebra Medical Vision said this week it won FDA 510(k) clearance for its Coronary Calcium Scoring algorithm. The company said the algorithm is designed to automatically calculate a patient’s Agatston equivalent coronary calcium score from ECG gated CT scans to improve assessments of patients at risk for coronary artery disease. “Identification of […]
7 medtech stories we missed this week: July 13, 2018
From Angiodroid receiving CE Mark approval to Masimo launching its vital signs app, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Angiodroid wins CE Mark for Angiopulse IABP Angiodroid announced in a July 11 press release that it has received CE Mark approval for its AngioPulse intra-aortic balloon […]
EchoNous wins FDA nod for EchoNous Vein ultrasound catheter guide
EchoNous said today it won FDA 510(k) clearance for its EchoNous Vein ultrasound device intended to improve peripheral IV catheter placements. The Seattle-based company said its EchoNous Vein system is designed to provide real-time, clear images at depths from one to five centimeters for visualizing superficial and deeper veins. “EchoNous Vein’s simple on-screen controls allows clinicians […]
IsoRay wins FDA nod for GammaTile brain tumor treatment
IsoRay (NYSE:ISR) said today it won FDA 510(k) clearance for its GammaTile brachytherapy technology designed for treating recurrent brain tumors. The Richland, Wash.-based company’s GammaTile is a radiation system using Cesium-131 radiation seeds embedded in a collagen ’tile’ which is designed to be placed in surgical margins at the time of surgery. IsoRay said it had […]
Intuitive Surgical wins FDA nod for 60mm stapler
Intuitive Surgical (NSDQ:ISRG) said today that the FDA cleared its fully-wristed 60 mm stapler, SureForm 60. The device is a single-patient-use stapler featuring 120 degrees of fully-wristed articulation, which Intuitive touts as “an industry first.” Beyond the 60 mm device, Intuitive’s stapling portfolio includes 30 and 45 mm stapler instruments. The stapler uses Intuitive’s SmartFire software […]
Arthrosurface nabs 510(k) clearance for patellofemoral WaveKahuna arthroplasty system
Arthrosurface said last month that it won 510(k) clearance from the FDA for its patellofemoral WaveKahuna arthroplasty system. The Franklin, Mass.-based company’s PF WaveKahuna device is designed to restore the articular surface geometry of the patella and femoral trochlea. The system tackles the challenging PF tracking and stability conditions and gives increased coverage of the […]
Gel-E wins FDA OTC nod for gel-e Flex flowable hemostat
Early stage wound care company Gel-e said today it won FDA 510(k) clearance for its gel-e Flex as an over-the-counter flowable hemostat. The College Park, Md.-based company said the clearance expands the labeling for the local management of lacerations and minor bleeding, and said the products were specifically designed to be usable by both trained professionals and […]
Apollo Endosurgery wins expanded FDA nod for OverStitch Sx system
Apollo Endosurgery said today it won special FDA 510(k) clearance for its OverStitch Sx endoscopic suturing system, an accessory for its already cleared OverStitch Sx system intended to simplify attachment of the device to compatible endoscopes. The Austin, Texas-based company said that the special clearance is the last regulatory nod it needed before it could introduce […]
Renovis wins FDA nod for Tesera ALIF interbody spinal fusion system
Renovis Surgical Technologies said today that it won 510(k) clearance from the FDA for its Tesera SA hyperlordotic ALIF interbody spinal fusion system. The company’s porous, titanium, stand-alone anterior lumbar interbody fusion system features a four-screw design and a locking cover plate designed to prevent screw backout. Renovis’ Tesera implants are made using additive manufacturing, […]
Embolx wins FDA nod for next-gen Sniper balloon occlusion microcath
Embolx said today that it won FDA 510(k) clearance for its next-gen Sniper balloon occlusion microcatheters designed for pressure-directed arterial embolization therapy. The Sunnyvale, Calif.-based company said that improvements to its next-gen Sniper microcath are intended to enhance access and navigation through small complex vascular structures. The catheter is available in 110 cm, 130 cm […]