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Total 467 results found since Jan 2013.

St. Jude wins FDA nod for Amplatzer PFO occluder
St. Jude Medical (NYSE:STJ) today won FDA approval for its Amplatzer patent foramen ovale occluder device, designed to reduce the risk of stroke in patients who’ve experienced a PFO-related stroke. Approximately 25-30% of Americans have a PFO, according to the FDA, which typically causes no health problems and does not require treatment. While the cause of most strokes can generally be identified, some patients experience strokes which cannot be medically identified, known as cryptogenic stroke. A small percentage of cryptogenic strokes are believed to be caused by PFOs, which provide a path for a blood clot to trav...
Source: Mass Device - October 28, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance St. Jude Medical Source Type: news

Legal win leaves Vascular Solutions CEO Root weary of the corner office
Root After being acquitted of federal felony charges for off-label marketing and a prosecution that spanned 5 years, Vascular Solutions (NSDQ:VASC) CEO Howard Root said he’s still recovering from the strain of battling federal prosecutors. Root, a lawyer, said if it wasn’t for his previous life in the field of law he would have cracked under the pressure of the investigation. And even with that training, the experience made him question staying in the industry. “I don’t want to do this job anymore. I feel like I’m getting pushed out. I was a lawyer, I started a medical device company. I crea...
Source: Mass Device - October 24, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Legal News Vascular Solutions Inc. Source Type: news

U.S. diabetics have worsening blood sugar
(Reuters) — The number of U.S. diabetics with healthy blood sugar levels has declined in recent years, a study suggests. Researchers analyzed data on 1.6 million adults with diabetes from 2006 to 2013. During this period, the proportion with HbA1c below 7% declined from 56% to 54%, and the share with HbA1c at or above 9% rose from 10% to 12%. “Clearly, there is a sizable proportion of patients with poor glycemic control – and many of them are young,” said lead author Kasia Lipska of Yale University. “We need to do better for them.” The researchers examined data on prescriptions and blood sugar test results to ...
Source: Mass Device - October 17, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Big Data Clinical Trials Diabetes Yale University Source Type: news

Occlutech recalls cardiac implant on dislodgement risk
Structural heart disease implant developer Occlutech said it’s recalling some of its Occlutech left atrial appendix occluders over risks of dislocation of the device both during and post-procedure. The Occlutech LAA occluder is designed for the minimally invasive closure of the LAA to reduce the risk of stroke in patients with atrial fibrillation. The device consists of a flexible nitinol wire mesh and loop anchoring and sealing technology, the Swiss company said. The company said that during both the LAA trial and commercial use, 4 dislocations were reported. After reviewing the dislocations, the company said it...
Source: Mass Device - October 14, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Recalls Occlutech GmbH 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

Study is 1st to quantify ‘ brain hacking ’ tDCS fields
Researchers have successfully visualized the field of effect of transcranial direct current stimulation using a novel magnetic resonance imaging technique, according to a new study. Results from the study were published in the journal Nature last month. Therapeutic procedures with tDCS are used to apply sustained changes in motor evoked potentials, and the technique has been shown to improve symptoms of neurologic and psychiatric disorders including epilepsy, Parkinson’s, depression, stroke and chronic pain. The use of tDCS has even been shown to improve learning, modulate working memory and invoke other cognitive benefi...
Source: Mass Device - October 4, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Neurological Neuromodulation/Neurostimulation Source Type: news

InspireMD pulls trigger on 1-for-25 reverse split
InspireMD (NYSE:NSPR) said yesterday it initiated a 1-for-25 reverse split of its stock, effective Oct. 7, with its stock trading on a split adjusted basis starting Oct. 10. The move will reduce the shares of InspireMD on the market by putting 1 share of common stock in the hands of shareholders for every 25 shares they held previously. No fractional shares will be distributed in the reverse split, the company said. The reverse split was approved at a special meeting of stockholders held yesterday, Boston-based InspireMD said. The number of authorized shares of the company’s common stock will remain at 150 million,...
Source: Mass Device - September 29, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News InspireMD 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

Claret Medical files for FDA clearance for Sentinel cerebral protection device
Claret Medical said today that it filed an application with the FDA seeking 510(k) clearance for its Sentinel cerebral protection system designed for use during transcatheter aortic valve replacements. The Santa Rosa, Calif.-based company’s Sentinel device is designed to capture and remove embolic debris dislodged during TAVR procedures, which can enter cerebral circulation and can potentially lead to strokes. “Our contribution in building significant new science will help the rapidly growing TAVR field embrace the critical role of cerebral protection in all left heart and endovascular procedures. These studi...
Source: Mass Device - September 20, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Vascular Claret Medical Inc. Stroke Source Type: news

Keystone Heart touts TriGuard cerebral protection data in TAVR patients
Keystone Heart today released data from transcatheter aortic valve replacement patients treated with its TriGuard cerebral embolic protection device, touting a significant reduction in brain lesions with use of the device. The TriGuard is a cerebral embolic protection device designed to reduce the amount of embolic material entering blood circulation to the brain during TAVR or TAVI procedures. Results come from preliminary study findings of 51 patients who underwent TAVR procedures, Keystone Heart said, and were presented at the PCR London Valves 2016 Conference in London. “These data, together with previously rep...
Source: Mass Device - September 19, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Vascular Keystone Heart Source Type: news

Medtronic touts CRT study showing heightened medication adherence
Patients implanted with cardiac resynchronization devices showed a greater rate of adherence to their medication regiments after their CRT devices were put it, according to a retrospective study Medtronic (NYSE:MDT) touted today. The analysis examined data from 4,512 patients who received CRT devices between January 2008 and December 2014, evaluating adherence to recommended medications before and after CRT implantation. Compliance increased 67% 2 years after CRT implantation when compared to 2 years pre-implantation, Fridley, Minn.-based Medtronic said. “These data support our commitment to understanding how we can...
Source: Mass Device - September 19, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Clinical Trials Cardiac Rhythm Management Medtronic Source Type: news

Silk Road Medical touts Medicare coverage decision for carotid procedures
Silk Road Medical said yesterday the Centers for Medicare and Medicaid Services granted coverage for transcarotid artery revascularization procedures, including those performed with the company’s Enroute transcarotid neuroprotection and stent system. The TCAR procedures are now eligible for coverage for patients who are treated with FDA-approved proximal embolic protection devices and approved carotid artery stent systems indicated for transcarotid procedures. The devices are also required to be entered into the national TCAR Surveillance Project, Sunnyvale, Calif.-based Silk Road Medical said. The company said it...
Source: Mass Device - September 16, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Stents Vascular Centers for Medicare and Medicaid Services (CMS) Silk Road Medical Inc. Source Type: news

MassDevice.com +5 | The top 5 medtech stories for September 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. Light-based arrhythmia treatment skips the shocks Researchers at Johns Hopkins University and Germany’s University of Bonn showed that light can restore a normal heartbeat and replace electric shocks in patients at risk for a...
Source: Mass Device - September 14, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 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

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