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 […]
Report: Med device recalls in Q2 highest since 2005
Medical device recalls during the second quarter hit 360, the highest amount seen since 2005, according to a new Stericycle Expert Solutions report. Recalls were up 17, or 5% from the previous quarter, according to the report. Recalled units decreased 80% to approximately 42.4 million, lower than eight of the previous 13 quarters, according to […]
Masimo touts study exploring pulse oximetry pre-screening for OSA in children with down syndrome
Masimo (NSDQ:MASI) yesterday released results from a study exploring home pulse oximetry monitoring’s ability to serve as an initial screening method to determine which children with Down syndrome should be recommended to undergo sleep studies to diagnose obstructive sleep apnea. The Irvine, Calif.-based company said that children with Down syndrome are at high risk of obstructive […]
BARDA, J&J launch ‘reimagined’ emergency respiratory device challenge
The Dept. of Health and Human Services’ Biomedical Advanced Research and Development Authority and Johnson & Johnson‘s (NYSE:JNJ) Janssen R&D are launching a new crowdsourced tech development challenge looking to support innovative respiratory protection devices, according to a recently listed government posting. The new contest, dubbed the QuickFire Challenge, will look to award up to […]
Conavi Medical touts first investigational use of Novasight hybrid IVUS-OCT system
Conavi Medical yesterday announced the first use of its Novasight hybrid system designed for imaging coronary arteries through both intravascular ultrasound and optical coherence tomography as part of an investigational trial. The system was used in its first procedure under a Health Canada Investigational Testing Authorization at Hamilton General Hospital by study co-investigators Dr. Tej […]
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 […]
IBM pushes back on negative Watson Health stories
IBM Watson Health (NYSE:IBM) is pushing back against reports that its artificial intelligence powered products deliver less than promised, claiming that the reports are unfair and ignore its capabilities. A number of news outlets, including The Wall Street Journal and STAT News, have recently published criticisms of IBM’s Watson Health offerings, claiming that its capabilities fall […]
Report: Women in Australia to pursue class action over Bayer’s Essure
A group of women in Australia will be joining other women worldwide in pursuing a class action lawsuit against Bayer (ETR:BAYN) for medical problems allegedly associated with its Essure permanent birth control device, according to a report from The Guardian. The suit, which will be led by law firm Slater and Gordon, joins similar suits against […]
Augmedics launches first-in-human Xvision-spine AR nav system trial
Surgical VR developer Augmedics said last week it began the first-in-human clinical trial of its Xvision-spine augmented reality surgical navigation center. The trial was launched at at Israel’s Sheba Tel Hashomer Medical Center and Asaf Harofeh Medical Center, led by co-principal investigators Dr. Ran Harel and Dr. Yigal Mirovsky. The Xvision-spine system is an AR surgical navigation […]
Covalon Tech lands $17m credit facility
Covalon Technologies said last week it inked a new $17 million banking credit facility with HSBC bank to help fund acquisitions and operations. The new banking agreement includes a $6.8 million (CAD $9 million) acquisition demand line which is repayable over five years, a $3.8 million (CAD $5 million) revolving operating facility and a $2 million […]
Endologix pushes Nellix release timeline to 2021
Endologix (NSDQ:ELGX) said it doesn’t expect to receive FDA premarket approval for its Nellix 3.5 endovascular sealing system until 2021. The Irvine, Calif.-based company this week updated on its estimated timeline for anticipated FDA approval, saying it expects to land premarket approval for the Nellix stent graft by the first half of 2021. The forecast is […]
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