Filtered By:
Source: Mass Device
This page shows you your search results in order of relevance. This is page number 14.
Order by Relevance | Date
Total 467 results found since Jan 2013.
FDA OKs expansion of InVivo Therapeutics spinal scaffold study
InVivo Therapeutics (NSDQ:NVIV) said today that the FDA cleared an expansion of its Inspire study of its neuro-spinal scaffold, now set to enroll up to 20 patients, and announced the 9th and 10th implantation in the trial, though the 10th patient died of an unrelated stroke.
The Cambridge, Mass.-based company’s neuro-spinal scaffold is surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting.
The federal watchdog cleared the company to expand the trial for up to 20 evaluable patients. The decision came based off the review of 6-month safety data from the trial, InViv...
Source: Mass Device - July 12, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Spinal InVivo Therapeutics Corp. Source Type: news
Direct Flow raises $27 million
Direct Flow Medical raised raised $27.1 million in a new round of financing through the sales of select stock and warrants.
Money in the round came from 11 anonymous investors, with the company looking for another $5.2 million before closing the round, according to the filing.
The company said it raised the funds through the sale and issuance of Series A-1 preferred stock, Series AA preferred stock, convertible notes, warrants to purchase Series A-1 or preferred stock, Series A-1 or preferred stock upon exercise and the underlying common stock issuable upon conversion, according to an SEC filing.
The company has not yet r...
Source: Mass Device - July 22, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiovascular Direct Flow Medical Inc. 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
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
Japan approves Medtronic ’ s Reveal Linq cardiac monitor
Medtronic (NYSE:MDT) wasted no time in launching its Reveal Linq cardiac monitor in Japan, saying it plans to launch the device there this month now that the device won approval from the Ministry of Health, Labor & Welfare.
The Reveal Linq device is designed to be implanted beneath the skin on the upper left side of the chest for monitoring patients experiencing dizziness, palpitation, fainting or syncope, chest pain and cardiac arrhythmias. Billed as the world’s smallest cardiac monitor, it’s about ⅓ the size of a triple-A battery and is designed to work for 3 years using the company’s CareLink network. Its a...
Source: Mass Device - September 14, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Patient Monitoring Regulatory/Compliance Medtronic Source Type: news
Phenox touts pREset thrombectomy device trial data
German device maker Phenox today released data from a study of its pREset thrombectomy device, touting high rates of positive clinical outcomes and freedom from severe neurological deficits.
The 100-patient trial examined a total of 109 acute intracranial vessel occlusions treated with the pREset device, looking to evaluate the efficacy of the device, overall safety and long-term outcomes. The trial included patients with acute proximal occlusions of major cerebral vessels in both the anterior and posterior circulation, Bochum, Germany-based Phenox said.
Results indicated a 62.5% rate of positive clinical outcomes with fr...
Source: Mass Device - September 27, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Catheters Clinical Trials Neurological phenox Source Type: news
Hong Kong researchers use smartphone tech to screen thousands for atrial fibrillation
Researchers screened more than 13,000 Hong Kong citizens for atrial fibrillation using a smartphone-based, wireless, single-lead ECG, according to a study published yesterday in Heart.
Afib can increase a person’s risk of heart failure and ischemic stroke, which can result in permanent neurological disability. Oral anticoagulation therapy can reduce the risk of ischemic stroke, but there is widespread under-treatment in patients with afib, according to an editorial published in the journal.
Get the full story at our sister site, Medical Design & Outsourcing.
The post Hong Kong researchers use smartphone tech ...
Source: Mass Device - October 13, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Cardiovascular Research & Development Cardiac Rhythm Management Source Type: news
MassDevice.com +5 | The top 5 medtech stories for November 14, 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.
Get this in your inbox everyday by subscribing to our newsletters.
5. Final FDA rules clarify adverse event reporting for contract manufacturers
The FDA last week issued final guidance for medical device companies on the requirements for reporting adverse events that walked back much of the burde...
Source: Mass Device - November 14, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Siemens Healthineers inks deal with N.Y. provider Northwell Health
Siemens Healthineers (NYSE:SI) said today it inked a 4-year research deal with N.Y. state healthcare provider Northwell Health.
The 2 parties aim to develop research projects evaluating clinical effectiveness and outcomes using data analytics-based population health evidence. As part of the 4-year partnership deal, Siemens Healthineers will also provide full-time employees who will work jointly with Northwell Health.
“This partnership is first-of-its-kind for both Siemens Healthineers and Northwell Health to collaborate on research that could potentially define care pathways for various populations in the future. We...
Source: Mass Device - December 1, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Clinical Trials Research & Development Siemens Healthineers Source Type: news
Layoffs ahead for ReWalk Robotics
ReWalk Robotics (NSDQ:RWLK) is reportedly planning to cut its operating expenses by 30% in 2017, a move that’s slated to include layoffs for an unspecified number of workers.
The Marlborough, Mass.- and Israel-based company said it aims to meet its goal partially via a “reduction in staffing.” ReWalk had 87 employees as of December 2015, according to a regulator filing.
“In the years since ReWalk received its FDA clearances for spinal cord-injured individuals, we have seen the market evolve, albeit slowly,” CEO Larry Jasinski said in prepared remarks. “Taking an industry-wide assessme...
Source: Mass Device - January 11, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Prosthetics Robotics Wall Street Beat ReWalk Robotics Source Type: news
MassDevice.com +5 | The top 5 medtech stories for March 8, 2017
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.
Get this in your inbox everyday by subscribing to our newsletters.
5. Court clears Caldera’s $12.3m transvaginal mesh settlement
A California federal judge last week approved a $12.3 million deal to settle a number of insurance claims over injuries allegedly caused by Caldera Medical’s transv...
Source: Mass Device - March 8, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
AliveCor raises $30m, launches Kardia Pro platform in U.S.
AliveCor said today that it landed $30 million in a series D funding round and that it released its artificial intelligence-enabled Kardia Pro platform in the U.S.
The company’s platform enables doctors to remotely monitor their patients for early signs of atrial fibrillation, a common cardiac arrhythmia.
“Heart disease is the No. 1 cause of death in the United States, claiming more lives than all forms of cancer combined. To manage heart disease and stroke risk, leading cardiologists want to see more than just ECGs from their patients,” CEO Vic Gundotra said in prepared remarks. “Kardia Pro tracks important meas...
Source: Mass Device - March 16, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Cardiovascular Funding Roundup Patient Monitoring Wall Street Beat AliveCor Source Type: news
MassDevice.com +5 | The top 5 medtech stories for March 17, 2017
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.
Get this in your inbox everyday by subscribing to our newsletters.
5. GlucoMe tackles connected diabetes management with acoustic data transmission
The Centers for Disease Control & Prevention predict that by 2050, if current trends continue, 1 in 3 adults in the U.S. will have diabetes. The d...
Source: Mass Device - March 17, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: News Well Plus 5 Source Type: news
ACC 2017 Roundup: Medtronic ’ s CoreValve as good as surgery in intermediate-risk trial
The team at MassDevice.com and Drug Delivery Business News will be updating this post periodically as news comes out of ACC 2017, the annual American College of Cardiology meeting in Washington March 17-19.
Medtronic’s CoreValve as good as surgery in intermediate-risk trial
A study comparing surgical valve replacement with transcatheter aortic valve replacement using the CoreValve device made by Medtronic (NYSE:MDT) showed that the TAVR device was as safe as surgery in intermediate-risk patients, according to data presented today at ACC 2017.
Two-year data from the 1,657-patient Surtavi study, presented at ACC 2017 a...
Source: Mass Device - March 17, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves ACC 2017 Medtronic Source Type: news
Nico wins CE Mark for BrainPath
Nico Corp said today it won CE Mark approval in the European Union for its BrainPath neurosurgery access device.
The BrainPath system uses a shunt and specially designed instrumentation to give surgeons access to the subcortical section of the brain.
“Gaining CE Mark approval for BrainPath is our first step in answering increasing global interest in a systems approach to subcortical brain surgery using a standardized approach. We intend to take a planned approach to global expansion and look forward to making a positive difference in the worldwide brain tumor and stroke incidence rate,” CEO Jim Pearson said i...
Source: Mass Device - April 3, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Neurological Regulatory/Compliance Surgical Nico Corp. Source Type: news
