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Source: Mass Device
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FDA clears Imperative Care ’ s stroke treatment catheters
Stroke-treatment startup Imperative Care (Campbell, Calif.) said it has landed FDA approval for its first line of access catheters.
Access to brain blood vessels can be challenging because of the brain’s highly complex and twisted vascular structure. The catheters were designed to deliver interventional treatments during minimally invasive neurovascular procedures for aneurysms, stroke, and other brain blood-vessel conditions, the company said.
“Recognizing the significant need to elevate the standard of patient therapeutics in stroke, Imperative Care was founded to become the comprehensive stroke company innovat...
Source: Mass Device - January 24, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Food & Drug Administration (FDA) Neurological News Well Research & Development imperativecare Source Type: news
11 innovative medical devices you need to know from 2018
[Image from unsplash.com]Call it digital health or mHealth or simply what it is — innovation. Last year we saw a lot of innovative wireless devices for diagnostics and treatment as research and development flourished.
Many researchers have taken up the challenge of developing devices that are portable, small and convenient with ease-of-use that could revolutionize point-of-care diagnostics .
From a defibrillator for stroke to a smartphone app that can detect infectious diseases, here are 11 innovative medical devices that got our attention in 2018.
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The post 11 innovative medical devices you need to know fro...
Source: Mass Device - January 18, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Featured Imaging Implants mHealth (Mobile Health) Research & Development bacteria-on-a-chip Cerebrotech diabetes electroCore Massachusetts Institute of Technology MedTech neurodegenerative diseases plug-and-play University of Cal Source Type: news
IschemaView wins expanded FDA nod for Rapid neuroimager
Medical imaging dev IschemaView said today that it won expanded FDA clearance for its Rapid neuroimaging platform intended for use in selecting patients likely to benefit from endovascular thrombectomy.
With the clearance, the Menlo Park, Calif.-based company said that its Rapid CT-Perfusion and Rapid MR-Perfusion devices can now be used to aid in selecting acute stroke patients with known occlusions of the internal carotid artery or proximal middle cerebral artery for a clot removal procedure.
IschemaView touted its Rapid system as the only imaging platform approved for selecting stroke patients for clot removal.
“T...
Source: Mass Device - January 15, 2019 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Imaging Neurological Regulatory/Compliance ischemaview Source Type: news
InspireMD inks distro deal for CGuard in South Africa
InspireMD (NYSE:NSPR) said today that it inked a deal with Torque Medical to distribute its CGuard Embolic Prevention System in South Africa.
The Israel-based company reported that it will begin the commercial launch for CGuard in South Africa immediately.
“We are extremely pleased with the opportunity to offer CGuard EPS in the South African market. We were approached by some of our key customers in the Vascular Surgery, Interventional Neurology and Interventional Cardiology field who had learned about CGuard EPS through conferences and publications and wanted us to make it available in South Africa,” Craig G...
Source: Mass Device - January 14, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Distribution Featured Vascular Wall Street Beat InspireMD Source Type: news
Terumo ’ s MicroVention wins FDA approval for Web brain aneurysm device
Terumo (OTC:TRUMY;TYO:4543) subsidiary MicroVention said today that it won pre-market approval from the FDA for the Web brain aneurysm device it acquired when it bought Sequent Medical back in 2016.
Aliso Viejo, Calif.-based MicroVention said the PMA for the Web embolic coil covers the treatment of intracranial wide neck bifurcation aneurysms.
“We are proud to offer our latest innovation to the neuroendovascular market in the United States with the introduction of the Web system, achieving the most rigorous standard of FDA approval through the PMA process,” MicroVention president & CEO Richard Cappetta sai...
Source: Mass Device - January 7, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Food & Drug Administration (FDA) Neurological Regulatory/Compliance MicroVention-Terumo Inc. Sequent Medical Source Type: news
Korean JLK Inspection launches AI-powered imaging diag system
Korean JLK Inspection said yesterday that it launched its AIHub artificial intelligence-powered medical image diagnostics platform.
The newly launched AIHub system is designed to analyze images from a number of different imaging modalities, including magnetic resonance imaging, computed tomography, X-ray and mammography, the Seoul-based company said.
JLK Inspection claims the system can detect and monitor for more than 30 medical conditions in 14 regions of the body. The company added that the system is focused on brain diseases and conditions including ischemic stroke, hemorrhagic stroke, brain aneurysm and Alzheimer̵...
Source: Mass Device - December 27, 2018 Category: Medical Devices Authors: Fink Densford Tags: Diagnostics Imaging Software / IT jlkinspection Source Type: news
Omron launches HeartGuide watch-based wearable BP monitor
Omron Healthcare (TYO:6645) said late last week that it launched its HeartGuide wearable blood pressure monitor, touting it as the world’s first such device.
The HeartGuide is an FDA-cleared, wearable oscillometric blood pressure monitor intended for personal use and styled to function as a wrist watch, the Lake Forest, Ill.-based company said. The device features a cuff in the wrist watch band which inflates to measure systolic and diastolic pressures at a clinical level of accuracy, the company claims.
The newly launched HeartGuide also monitors physical activity including steps taken, distance walked, calories b...
Source: Mass Device - December 27, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Diagnostics Featured Omron Omron Healthcare Source Type: news
Study: Catheter ablation better for AFib, heart failure than drugs
A meta-analysis of randomized controlled trials has found that catheter ablation was superior to conventional drug therapy alone for patients with atrial fibrillation (AFib) and heart failure.
AFib may lead to thromboembolic stroke, systemic embolism, and decompensated heart failure. Although catheter ablation is an established therapeutic strategy for AFib, guidelines recommend caution in certain patients, and the benefits and harms of catheter ablation versus drug therapy for Afib patients have not been firmly established.
Get the full story on our sister site, Medical Design & Outsourcing.
The post Study: Catheter a...
Source: Mass Device - December 26, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiovascular Catheters Research & Development icahnschoolofmedicine Source Type: news
InspireMD touts results of next-gen stroke prevention stent study
InspireMD (NYSE:NSPR) has released the results of a meta-analysis of four clinical studies involving dual-layered (DLS) and mesh-covered stents, including the company’s MicroNet-covered stent, the CGuard embolic prevention system.
The analysis concluded that carotid artery disease patients treated with mesh-covered stents experienced a 30-day minor stroke rate of 1.25%, lower than the 30-day minor stroke rates reported in other widely cited studies, such as CREST and ACT 1, for patients treated with both carotid endarterectomy and with those treated with conventional carotid stents. CREST and ACT 1 also involved lower...
Source: Mass Device - December 24, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiovascular Research & Development Stents InspireMD Terumo Source Type: news
J & J ’s Cerenovus launches global thrombectomy registry
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus said today that it launched a new registry aiming to collect and analyze stroke-inducing blood clots removed with the company’s Embotrap II revascularization device.
The Irvine, Calif.-based company touted the Excellent registry as the single largest global registry of its kind to date, looking to enroll up to 1,000 ischemic stroke patients across 50 locations in the U.S. and Europe. Investigators in the trial will collect and analyze clots removed to explore how different characteristics, including size, composition and density may affect outcomes, the company said.
I...
Source: Mass Device - December 10, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Featured Neurological cerenovus johnsonandjohnson Source Type: news
Corindus touts first-in-human coronary telerobotics study with CorPath system
Corindus Vascular Robotics (OTC:CVRS) today touted that its CorPath robotic surgical platform was used in a first-in-human telerobotic intervention study in India.
The Waltham, Mass.-based company touted that the study was the world’s first percutaneous coronary intervention conducted from a remote location outside of a catheterization lab.
In the trial, five patients at India’s Apex Heart Institute underwent an elective PCI procedure from a distance of approximately 20 miles away, Corindus said.
The procedures were performed by Apex Heart Institute chair and chief interventional cardiologist Dr. Tejas Patel f...
Source: Mass Device - December 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Featured Robotics Corindus Vascular Robotics Source Type: news
Medtronic to pay $51m to settle Covidien, ev3 DoJ investigations
Medtronic (NYSE:MDT) said yesterday that it agreed to pay $50.9 million to settle a number of U.S. Dept. of Justice probes into marketing activities from companies it acquired, Covidien and ev3.
Medtronic said that its subsidiary ev3, acquired when the Fridley, Minn.-based medtech giant picked up Covidien in 2015, agreed to plead guilty to a misdemeanor charge related to its marketing of the Onyx Liquid Embolic System, pay $17.9 million and adopt new compliance and reporting terms for three years.
The charges relate to ev3’s marketing of the device for “unproven and potentially dangerous uses,” federal prose...
Source: Mass Device - December 5, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Legal News Medtronic Source Type: news
Conformal Medical raises $9m Series B for anti-stroke cardiac implant
Conformal Medical said today that it raised $9 million in a Series B round for the anti-stroke cardiac implant it’s developing.
Nashua, N.H.-based Conformal is working on a left atrial appendage seal to prevent stroke in atrial fibrillation patients. It’s designed to adapt to the each patient’s individual physiology, to be easier to implant with less imaging and without general anesthesia.
The funding round was led by Catalyst Health Ventures and included “a supportive group of Series A investors,” Conformal said.
“This financing will allow us to validate our novel sealing technology ...
Source: Mass Device - December 3, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Implants Featured Funding Roundup Wall Street Beat Conformal Medical Source Type: news
Samsung ’ s NeuroLogica, MaxQ AI ink collab distro deal
Samsung Electronics (LON:BC94) subsidiary NeuroLogica said today that it inked a distribution deal with MaxQ AI to integrate its artificial intelligence software with NeuroLogica’s medical imaging tech in the U.S. and EU’s acute care marketplace.
Through the deal, NeuroLogica said that it will offer MaxQ’s Accipio IX, part of the AI-company’s FDA-cleared and CE Mark approved Accipio Insight intracranial hemorrhage platform intended to support acute care physicians by identifying patients with suspected intracranial hemorrhage using non-contrast head computed tomography imaging.
“We are honore...
Source: Mass Device - November 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Distribution Imaging Neurological Software / IT maxqai NeuroLogica Corp. samsung Source Type: news
Nico raises $13m Series B for neurosurgery devices
Nico Corp. said today that it raised nearly $13 million in a Series B round from a group of existing backers for its line of neurosurgery devices.
Indianapolis-based Nico said the $12.5 million round is earmarked for new product development and commercialization, clinical and economic studies, growing its sales and clinical teams, and expanding its footprint in Europe.
“Our shareholders have again confirmed their commitment and confidence in the value and outcomes of Nico technologies and our ability to both grow and create new markets in neurosurgery,” president & CEO Jim Pearson said in prepared remarks....
Source: Mass Device - November 19, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Funding Roundup Neurological Surgical Wall Street Beat Nico Corp. Source Type: news
