BioSig Technologies (OTCQB: BSGM) said today it won FDA 510(k) clearance for its Pure EP electrophysiology system. The Santa Monica, Calif.-based company said the PureEP system is designed for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology procedures. The newly cleared system is intended to reduce […]
7D Surgical wins FDA nod for MvIGS nav system Cranial Module
Canadian medical device firm 7D Surgical said yesterday it won FDA 510(k) clearance for a Cranial Module for its Machine-vision Image Guided Surgery system. The Toronto-based company’s 7D Surgical System uses 3D optical technologies which require only natural light, as well as machine vision algorithms. The system’s navigation technology is embedded in an overhead surgical light […]
Study slams FDA’s ‘fast-track’ approval process
More than 98% of the 161 foot and ankle implants that were recalled from 2007 through 2017 were approved through the FDA’s 510(k) process, according to a new study. That left one recalled device approved via the more stringent premarket approval (PMA) process and two for which the submission procedure was not indicated. The 510(k) process allows […]
Strat Skin Sciences wins FDA nod for Multi-Micro Dose excimer laser tip
Strata Skin Sciences (NSDQ:SSKN) said yesterday it won FDA 510(k) clearance for the Multi-Micro Dose tip designed for use with its Xtrac 308nm excimer laser. The newly cleared tip is indicated for use in conjunction with the Horsham, Penn.-based company’s Xtrac laser system to filter narrow band UVB light at delivery, intended to individualize non-blistering doses […]
7 medtech stories we missed this week: August 3, 2018
From Esaote launching its new ultrasound device to Nipro’s Infraredx launching in Japan, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Esaote launches new ultrasound devices Esaote announced in an Aug. 2 press release that it has launched its new MyLab X7, MyLab X6 and MyLab X5 ultrasound […]
NuVasive wins FDA nod for Pulse spinal surgical automation platform
NuVasive (NSDQ:NUVA) said today it won FDA 510(k) clearance for its Pulse spinal surgical automation platform. The newly cleared Pulse system includes both 2D and 3D navigation and smart imaging capabilities with integrated neuromonitoring, surgical planning, radiation reduction and patient-specific rod bending tech, the San Diego-based company said. “Pulse seamlessly integrates multiple intraoperative technologies through an intuitive […]
7 medtech stories we missed this week: July 27, 2018
From the FDA clearing LifeSignal’s wireless ECG to Zavation receiving FDA clearance for its expandable corpectomy cage, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears LifeSignal’s wireless ECG LifeSignals announced in a July 26 press release that it has received FDA clearance for its wireless LP1100 Life […]
Netflix’s ‘The Bleeding Edge’ blasts medtech & FDA
Netflix has unleashed a blistering indictment of the medical device industry, the FDA and doctors who accept money from medtech in its new documentary, ‘The Bleeding Edge,’ released today. The film depicts people who have suffered injuries and/or illnesses following placement of Bayer’s Essure sterilization device, Johnson & Johnson’s vaginal mesh, various manufacturers’ metal artificial […]
Vallum wins FDA nod for nano-textured PEEKplus spinal implant
Vallum Corp said today it won FDA 510(k) clearance for its PEEKplus nanotextured spinal interbody fusion device, touting it as the first nanotextured PEEK interbody device to win an FDA nod. The Nashua, N.H.-based company’s PEEKplus nanotextured surface features nano-scale concavities of between 20 and 50 nanometers created by the impact of argon atoms across […]
SuperSonic Imagine wins FDA nod, CE Mark for Aixplorer Mach 30 ultrasound
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 […]
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 […]
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