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Source: Mass Device
Procedure: Ultrasound
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Total 16 results found since Jan 2013.
Philips launches Epiq Elite ultrasound system
Philips (NYSE:PHG) said yesterday that it launched its new Epiq Elite ultrasound system.
The newly launched system from the Amsterdam company contains its “latest advances in transducer innovation,” as well as its first solution for vascular assessment and diagnosis.
“Our new portfolio of dedicated systems and solutions based on the EPIQ Elite combines new display technology, innovative transducers, advanced software and enhanced processing power. With one in four stroke cases caused by vascular disease of the carotid artery in the neck, vascular health is a growing concern worldwide. Ultrasound is the i...
Source: Mass Device - February 8, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Imaging Ultrasound Royal Philips Source Type: news
EBR Systems launches trial for wireless pacer
EBR Systems said yesterday that it launched a 350-patient investigational device exemption trial of its Wise wireless pacemaker it hopes to use to win FDA approval.
Sunnyvale, Calif.-based EBR’s device uses a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted in the right ventricle, which it uses to synchronize the left and right ventricles. The system is designed to eliminate the need for a left ventricular lead by allowing the operating physician to place the stimulation “pellet” in a patient-specific location inside the left ventricle.
The FDA approved the Solve-CRT stu...
Source: Mass Device - March 8, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Cardiac Rhythm Management EBR Systems Inc. Source Type: news
7 medtech stories we missed this week: Oct. 20, 2017
[Image from unsplash.com]From InspireMD’s distribution deal to RenalGuard touting a new study, here are seven medtech stories we missed this week but thought were still worth a mention.
1. InspireMD inks Chile distribution deal
InspireMD announced in an Oct. 12 press release that it has signed a distribution deal with CorpMedical Chile to distribute the MGuard Prime Embolic Protection System (EPS). The MGuard Prime EPS treats acute coronary syndromes like acute myocardial infarctions.
2. Medacta launches MiniMed hip stem
Medacta has launched its MiniMAX Hip System in the U.S., according to an Oct. 12 press release. ...
Source: Mass Device - October 20, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Cardiovascular Clinical Trials Diagnostics Food & Drug Administration (FDA) Implants Orthopedics Patient Monitoring Regulatory/Compliance Surgical Ultrasound Esaote Hill-Rom Holdings Inc. Honeywell InspireMD Medacta Source Type: news
Russian study pits InspireMD ’ s CGuard device against Abbott ’ s Rx Acculink carotid stent
InspireMD (NYSE:NSPR) this week touted an independent clinical trial in Russia pitting its CGuard embolic protection device against the Rx Acculink carotid stent made by Abbott (NYSE:ABT).
The 100-patient trial is designed to compare the two devices in terms of neuroprotection and clinical superiority in subjects undergoing carotid endarterectomy, the Tel Aviv-based company said. Conducted at the Scientific Research Institute of Circulation Pathology in Novosibirsk, the study is led by Dr. Andrei Karpenko.
The primary endpoint is new ischemic areas in the brain 24 to 48 hours post-procedure and new lesion permanence at...
Source: Mass Device - October 12, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Stents InspireMD Stroke Source Type: news
Neural Analytics launches study of transcranial doppler for evaluating mild-TBI
Neural Analytics said today it enrolled the 1st patient in a 2-year study exploring the use of its Lucid M1 transcranial doppler ultrasound system to evaluate cerebral blood flow in patients with mild traumatic brain injuries.
The Lucid M1 system is a portable all-in-one ultrasound system designed for measuring and displaying cerebral blood flow velocities in patients with brain disorders, the Los Angeles, Calif.-based company said.
In the 240-patient trial, researchers at the University of California Los Angeles will examine high school and college age enrollees in 3 separate groups, including those who have been affected...
Source: Mass Device - August 10, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Diagnostics Neurological Neural Analytics Source Type: news
Neural Analytics touts 95% accuracy for TCD platform in Expedite trial
Neural Analytics today released initial results from the Expedite study of its Transcranial Doppler Tech platform, touting 95% accuracy in the early detection of acute ischemic stroke due to large vessel occlusion.
Data from the study was presented at the 26th annual European Stroke Conference this week in Berlin.
The 45-subject trial examined the use of TCD scans in patients experiencing computer tomography angiography confirmed acute ischemic stroke due to large vessel occlusion of the internal carotid artery or middle cerebral artery.
Scans with the TCD platform were analyzed with 2 different stroke assessment algorith...
Source: Mass Device - May 24, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Diagnostics Neurological Ultrasound Neural Analytics Source Type: news
Neural Analytics raises $10m
Updated to include new information from neural analytics.
Neural Analytics raised $10.1 million in a new round of equity and options financing, according to an SEC filing posted this week.
The Los Angeles-based company develops the Lucid M1, a portable all-in-one ultrasound system designed for rapid triaging and monitoring of patients with brain disorders.
Neural Analytic’s system is a battery operated medical grade tablet device which uses transcranial doppler to assess the brains blood vessels from outside the body. Analyses with the system can be performed in office and can help diagnose brain disorders and avoid mor...
Source: Mass Device - April 10, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Neurological Ultrasound Neural Analytics Source Type: news
7 medtech stories we missed this week: Feb. 24, 2017
[Photo from unsplash.com]Several companies made distribution deals this week, while others received approval for their products. Here are 7 medtech stories we missed this week but were still worth mentioning.
1. Israel OKs E-Qure’s BST device for chronic wounds
E-Qure Corp. announced this week that it received marketing approval for its Bio-electrical Signal Therapy Device (BST Device) from the Israeli Ministry of Health, according to a Feb. 24 news release. BST is an electrotherapeutic method for treating chronic wounds. E-Qure will begin marketing its device in Israel by activating a signed distribution agreement with...
Source: Mass Device - February 24, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Electronic Medical Records Imaging Mergers & Acquisitions mHealth (Mobile Health) Regulatory/Clearance Align Technology Clarius Mobile Health Corin Group E-Qure Henry Schein Medical Nexstim Skyline Medical Source Type: news
Neural Analytics wins CE Mark for next-gen Lucid transcranial ultrasound
Neural Analytics said today it won CE Mark approval in the European Union for its next-gen Lucid M1 transcranial doppler ultrasound system.
The Los Angeles-based company’s Lucid M1 is a portable all-in-one ultrasound system designed for rapid triaging and monitoring of patients with brain disorders.
“The development of accurate and portable brain monitoring technology like the Lucid System is critical to expanding brain care in the 21st century. Healthcare professionals will be able to utilize this diagnostic tool in a variety of clinical settings to accurately measure the brain’s blood flow to expedite medic...
Source: Mass Device - January 25, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Imaging Neurological Regulatory/Compliance Neural Analytics Source Type: news
Neural Analytics lands $3M NIH grant
Neural Analytics landed a $3 million grant from the National Institutes of Health for the diagnostic and monitoring technology it’s developing for traumatic brain injury and stroke, the company reported. The NIH’s Small Business Innovation Research program funded the grant.
Los Angeles-based Neural Analytics, founded in 2013, develops technology to measure and track brain health, particularly traumatic brain injury, acute ischemic stroke, and dementia. The company is working on a portable ultrasound headset for athletes at risk of concussion.
With the NIH funding, they hope to create a portable device for 1st responder...
Source: Mass Device - September 14, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Diagnostics Funding Roundup Neurological National Institutes of Health (NIH) Neural Analytics Source Type: news
InspireMD opens $1.7 million in offerings to support embolic tech
InspireMD (OTC:NSPR) said today it is opening an underwritten public offering looking to bring in approximately $1.1 million through the sale of 1.9 million shares to support its CGuard EPS and MGuard Prime EPS.
The Boston-based company said it will offer up 1.9 million shares of common stock at 59¢ per share, with warrants issued for the purchase of up to an additional 950,000 shares of common stock for the same price for up to 5 years from the date of issuance.
InspireMD said it intends to use funds from the round to support sales activities related to its CGuard EPS and MGuard Prime EPS embolic protection devices, as...
Source: Mass Device - March 16, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Catheters Stents InspireMD Source Type: news
EU OKs add’l delivery cath for InspireMD’s CGuard stent
InspireMD (OTC:NSPR) said Wednesday it won European Union regulatory approval, including CE Mark approval, for the manufacturing and commercialization of its CGuard stent delivery catheter.
The approval also allows InspireMD to add-on manufacturing facilities for the device to enable more efficient work flow, the Boston-based company said.
“We are pleased to receive Dekra certification for our enhanced CGuard delivery catheter, used when delivering the CGuard EPS into the carotid anatomy, supporting a more profitable and fluid scaling of our manufacturing operations. Our CGuard system continues to be well received ...
Source: Mass Device - December 4, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Catheters Regulatory/Compliance Stents InspireMD Source Type: news
Nipro to sell diagnostics biz to China’s Sinocare for $273m
Nipro (TYO: 8086) said today it signed a deal sell its diagnostics business to China-based Sinocare for approximately $273 in cash.
Nipro Diagnostics, based in Ft. Lauderdale, Fla., develops, manufactures and markets diabetes products, including glucose monitors, the company said.
“This transaction combines 1 of the fastest growing blood glucose monitoring companies in the United States with the fastest growing blood glucose monitoring company in China. We have a shared vision and a singular focus to provide innovative and affordable solutions so patients can live healthier lives. Together, we will offer a strong p...
Source: Mass Device - October 27, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Diabetes Diagnostics Mergers & Acquisitions Nipro Sinocare Source Type: news
Medtech approvals: FDA releases August 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in August 2015:
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 70
Summary of PMA Originals Under Review
Total Under Review: 57
Total Active: 28
Total On Hold: 29
Summary of PMA Supplements Under Review
Total Under Review: 569
Total Active: 422
Total On Hold: 147
Summary of All PMA Submissions
Originals: 5
Supplements: 90
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 70
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 229.0
FDA Time: 130...
Source: Mass Device - October 23, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Source Type: news
Vittamed pulls in $10m Series A for intracranial pressure device
Vittamed said today it raised $10 million in a Series A round of funding to support its intracranial pressure neurodiagnostic sensor development and launch.
The funding round was led by Xeraya Capital Labuan and joined by existing investor Imprimatur Capital and other investors, the Boston-based company said.
“The financial support and expertise of Xeraya Capital will help us accelerate Vittamed’s commercial launch. We are excited about our potential to better diagnose and manage patients with many neurological conditions, including traumatic brain injury, hydrocephalus, stroke, and space occupying lesions incl...
Source: Mass Device - October 16, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Diagnostics Ultrasound Vittamed Source Type: news
