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FDA clears icometrix ’ MRI quantification software
Health tech software developer icometrix said today it won FDA 510(k) clearance for its icobrain image quantification software.
The company’s icobrain software is designed to quantify key features of clinical magnetic resonance imaging brain scans to allow clinicians to monitor changes in their patient’s brains over time.
“MRI biomarkers are becoming of vital importance in the clinical care path for various pathologies including neurological disorders such as multiple sclerosis, traumatic brain injury and stroke. It is of paramount importance that the biomarker measurements are extremely reproducible and ...
Source: Mass Device - September 9, 2016 Category: Medical Equipment Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Imaging Regulatory/Compliance Software / IT icometrix Source Type: news
Irregular heartbeat may be tied to more than just stroke risk
(Reuters) – Atrial fibrillation, a type of irregular heartbeat that’s already linked to an increased risk of stroke, may also be tied to higher risk of heart attack, heart failure, kidney disease and sudden death, according to a new research review.
“It was particularly noteworthy that the relative and absolute risk increase for heart failure was the highest among all outcomes examined, even higher than the risk of stroke, said lead author Ayodele Odutayo, a doctoral candidate at the University of Oxford in the U.K.
In atrial fibrillation, the upper chambers of the heart flutter or beat irregularly. Sometimes...
Source: Mass Device - September 8, 2016 Category: Medical Equipment Authors: MassDevice Tags: Cardiovascular American Heart Assn. Source Type: news
AliveCor partners with Omron to integrate BP data into Kardia mobile app
AliveCor said today it is partnering with Omron Healthcare to integrate data from its Bluetooth-enabled home blood pressure devices into AliveCor’s ECG Kardia mobile application.
The Mountain View, Calif.-based company said the integration marks the 1st consumer-ready, clinically validated electrocardiogram and blood pressure monitor application which provides heart health information and proactive monitoring.
“Giving patients the ability to monitor two vital heart health statistics for stroke in one place has the opportunity to be life-changing. With this combined data, patients can change their most importa...
Source: Mass Device - September 8, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Diagnostics mHealth (Mobile Health) AliveCor Omron Healthcare Source Type: news
Balt International buys Blockade Medical
European medtech firm Balt International said today it acquired endovascular device developer Blockade Medical for an undisclosed amount.
The acquisition is part of Balt’s ongoing strategy to bolster its neurovascular portfolio as well as efforts to develop a presence in the U.S., the company said.
“This acquisition is a first strategic move towards transforming Balt into an integrated global neurovascular device company. Balt is recognized as a 1st mover in the market thanks to a world-class R&D team, which has proven its ability and rapidity to develop blockbuster products such as the Leo stent, the Sil...
Source: Mass Device - September 2, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Mergers & Acquisitions Neurological Vascular Balt International Blockade Medical Source Type: news
FDA approves Concentric Medical ’ s Trevo clot retrievers
The FDA said today it granted expanded approval to 2 Stryker (NYSE:SYK) subsidiary Concentric Medical‘s Trevo clot retrieval devices, with new indications as initial therapy for strokes due to blood clots to reduce paralysis, speech difficulties and other stroke disabilities.
The indications expand the previously won clearance for the devices, won in 2012, which cleared the retrievers for removing blood clots and restoring blood flow in stroke patients who could not receive t-PA or for patients who didn’t respond to t-PA therapy.
“This is the first time FDA has allowed the use of these devices alongside...
Source: Mass Device - September 2, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Catheters Food & Drug Administration (FDA) Regulatory/Compliance Concentric Medical Inc. Stryker Source Type: news
MassDevice.com +5 | The top 5 medtech stories for September 1, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. Pivotal trial pits St. Jude Medical’s Amplatzer Amulet anti-stroke device against Boston Scientific’s Watchman
St. Jude Medical said today that it launched a U.S. pivotal trial for its Amplatzer Amulet cardiac implant, whic...
Source: Mass Device - September 1, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Deaths prompt FDA warning on Baxter ’ s Vascu-Guard patch
The FDA today released a notice warning of issues with Baxter‘s (NYSE:BAX) Vascu-Guard peripheral vascular patch after receiving multiple adverse event reports including 3 patient deaths potentially related to the issue.
The Vascu-Guard patch is designed for use in vascular reconstruction surgeries including carotid, renal, iliac, femoral, profund and tibial blood vessels and arteriovenous access revisions, the FDA said.
The federal watchdog said it has received reports of issues with intraoperative or postoperative bleeding and hematomas, some of which required clinical interventions and 3 patient deaths which occur...
Source: Mass Device - September 1, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Recalls Vascular Baxter International Source Type: news
Pivotal trial pits St. Jude Medical ’ s Amplatzer Amulet anti-stroke device against Boston Scientific ’ s Watchman
St. Jude Medical (NYSE:STJ) said today that it launched a U.S. pivotal trial for its Amplatzer Amulet cardiac implant, which is designed to reduce the risk of stroke in patients with atrial fibrillation.
The Amplatzer Amulet device is designed to occlude the left atrial appendage to prevent the formation of blood clots that could lead to a stroke. The FDA approved a similar device made by Boston Scientific (NYSE:BSX), the Watchman implant, in March 2015; St. Jude’s 1,600-patient IDE trial will compare the Amplatzer Amulet to the Watchman in patients with non-ventricular arrhythmias.
The primary safety endpoint is ...
Source: Mass Device - September 1, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Cardiovascular Clinical Trials Wall Street Beat Boston Scientific St. Jude Medical Source Type: news
Study: TAVR safer than surgery in low-risk heart failure patients
Transcatheter aortic valve replacement procedures with self-expanding systems resulted in higher survival rates for patients at lower risk for surgery when compared to surgical aortic valve replacement procedures, according to a study released this month.
Results from the study, which compared Medtronic‘s (NYSE:MDT) self-expanding CoreValve TAVR system, were published in JAMA Cardiology this month.
The retrospective analysis compared patients from the CoreValve U.S. pivotal high-risk trial of patients with STS PROM scores of 7% or less who either underwent TAVR procedures or surgery, with a median STS Prom score of...
Source: Mass Device - August 29, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Medtronic Source Type: news
Northwestern Memorial joins InVivo Therapeutics neuro-spinal scaffold trial
InVivo Therapeutics (NSDQ:NVIV) said today that Chicago’s Northwestern Memorial Hospital is the 23rd site to join the clinical trial of its neuro-spinal scaffold.
“Chicago, as with other major metropolitan areas, sees a disproportionally high number of acute, traumatic spinal cord injuries and unfortunately, with complete spinal cord injuries, trauma teams have limited tools at their disposal to treat this devastating condition. I look forward to being a part of the encouraging Inspire study,” site principal investigator Dr. Nader Dahdaleh said in prepared remarks.
“We welcome Dr. Dahdaleh and ...
Source: Mass Device - August 18, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Regenerative Medicine Spinal InVivo Therapeutics Corp. Source Type: news
Another InVivo Therapeutics spinal scaffold implant patient improves
InVivo Therapeutics (NSDQ:NVIV) said today that the 9th spinal cord injury patient, implanted with its neuro-spinal scaffold last month, is already showing signs of improvement.
InVivo’s neuro-spinal scaffold is surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting.
The 9th patient in a clinical trial improved from a complete to incomplete spinal cord injury on the the American Spinal Injury Assn.’s 50-point lower extremity motor score between the 2nd and 3rd month after implantation, Cambridge, Mass.-based InVivo said. The patient is the 5th of 8 patients...
Source: Mass Device - August 17, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Neurological Regenerative Medicine InVivo Therapeutics Corp. Source Type: news
FDA approves BioSense Webster ’ s Thermocool SmartTouch catheter
Johnson & Johnson (NYSE:JNJ) subsidiary Biosense Webster said today it won FDA premarket approval for its Thermocool SmartTouch SF catheter designed for ablation procedures.
The Diamond Bar, Calif-based company touted the Thermocool SmartTouch as the only FDA-approved catheter ablation device designed to combine contact force technology and a porous tip.
“The Thermocool SmartTouch SF Catheter represents a significant advancement for the clinical community. Conducted trials, including the Smart-AF and Smart-SF studies, have shown Biosense Webster technology enables physicians to achieve targeted stability in th...
Source: Mass Device - August 15, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Catheters Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance BioSense Webster Inc. Johnson & Johnson Source Type: news
InVivo Therapeutics Q2 meets the street, shares stay steady
InVivo Therapeutics (NSDQ:NVIV) shares stayed steady after the company released 2nd quarter earnings that met the street on losses per share.
The Cambridge, Mass.-based company reported losses of $5.2 million, or 16¢ per share, for the 3 months ended June 30, 2016. That amounts to a 50% reduction in losses for InVivo Therapeutics compared with same period in 2015.
After adjusting to exclude 1-time items, losses per share were 18¢, a good tick below what analysts on Wall Street were looking for with expectations set fro losses of 22¢ per share.
“The 2nd quarter was one marked by continued advancements and outreach...
Source: Mass Device - August 5, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Neurological Spinal InVivo Therapeutics Corp. Source Type: news
J & J ’ s Codman Neuro inks distro deal with InNeuroCo
Johnson & Johnson‘s (NYSE:JNJ) Codman Neuro said last week it inked an exclusive U.S. and European distribution deal with InNeuroCo for its intermediate catheters designed for the minimally invasive treatment of hemorrhagic stroke.
Codman Neuro made the announcement at the Society of NeuroInterventional Surgery’s 13th annual meeting, Codman Neuro said.
“Intermediate catheters are increasingly used by neurovascular specialists to facilitate the delivery of other devices, including stents and thrombectomy devices for the treatment of stroke. This agreement with InNeuroCo demonstrates our commitment to ne...
Source: Mass Device - August 2, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Distribution Neurological Codman Neuro Source Type: news
Micro Interventional Devices wins FDA nod for Permaseal
Micro Interventional Devices said today it won FDA 510(k) clearance for its Permaseal transapical access and closure device.
The Permaseal device is designed to allow surgeons to access and close the left-ventricle without having to suture the myocardium using the companies compliant soft-tissue PolyCor anchor technology.
“The FDA market clearance of Permaseal is another tremendous achievement for MID. This exciting development comes fast on the heels of our recent European approval. Sales in Europe are exceeding our early expectations. With the US approval, coming earlier than expected, MID will be initiating ...
Source: Mass Device - July 29, 2016 Category: Medical Equipment Authors: Fink Densford Tags: 510(k) Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Micro Interventional Devices Source Type: news
