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Source: Mass Device
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Total 467 results found since Jan 2013.
Silk Road launches Enroute transcarotid stent
Silk Road Medical said today it launched its Enroute Transcarotid stent system in the U.S., and that the stent was used in its 1st commercial commercial case.
The Enroute stent is indicated for use in patients at high surgical risk in conjunction with the company’s transcarotid Neuroprotection system, the Sunnyvale, Calif.-based company said. The stent is also the 1st designed to be implanted into the carotid artery through a common access point.
“The minimally invasive TCAR procedure allows me to safely and quickly treat a carotid artery blockage while minimizing the potential for nerve injury and cardiovascul...
Source: Mass Device - October 6, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Blog Silk Road Medical Inc. 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
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
Boston Scientific wins CE Mark for next-gen Watchman FLX
Boston Scientific (NYSE:BSX) said today it won CE Mark approval in the European Union for its Watchman FLX left atrial appendage closure device, and announced the device has been successfully implanted in its 1st set of patients.
The 1st Watchamn FLX devices were implanted last week by Dr. Horst Sievert of Frankfurt, Germany’s Sankt Katharinen Hospital, Dr. Vivek Reddy of Mt. Sinai Hospital in Prague’s Na Homolce Hospital and by Dr. Saibal Kar of Cedars-Sinai Heart Institute at Izola, Slovenia’s MC Medicor, Marlborough, Mass.-based Boston Scientific said.
“The Watchman Device is the most studied l...
Source: Mass Device - November 19, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Boston Scientific Source Type: news
MassDevice.com +3 | The top 3 medtech stories for November 24, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.
3. Ocular Therapeutix launches another pivotal for Dextenza eye drug-device combo
Ocular Therapeutix said today that it launched another pivotal trial for its Dextenza drug-device combination, its 2nd study of the treatment for an allergic conjunctivitis indication.
Bedford, Mass.-based Ocular Th...
Source: Mass Device - November 24, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news
Biotronik launches CLS-equipped pacer trial for treating syncope
Biotronik said today it enrolled the 1st patients in its BioSync CLS trial looking to examine whether its closed loop stimulation-equipped pacemakers can prevent syncope.
Recurrent syncope, or fainting, is often proceeded by a drop in blood pressure or heart rate, so patients diagnosed with the disorder are often indicated for pacemakers, Biotronik said.
“While not fatal, recurrent syncope is quite dangerous and seriously compromises the patient’s quality of life. Previous studies have provided contradictory results regarding the benefit of cardiac pacing in syncope, and the current European Society of Cardiology...
Source: Mass Device - December 10, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Clinical Trials Biotronik Source Type: news
FDA approves trial for low-risk patients with MDT’s CoreValve Evolut R
This study is an important next step in developing robust clinical evidence to help heart teams understand the potential benefits of TAVR in a broader patient population.”
Earlier this month, the FDA granted an expanded indication for the CoreValve devices for patients with end-stage renal disease and low-grade, low-flow aortic stenosis.
The post FDA approves trial for low-risk patients with MDT’s CoreValve Evolut R appeared first on MassDevice.
Source: Mass Device - February 22, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news
Medtronic launches CoreValve Evolut R trial in low-risk patients
Medtronic (NYSE:MDT) said yesterday that it launched another clinical trial for its CoreValve Evolut R replacement heart valve, aiming to win an expanded indication for low-risk patients.
The 1,200-patient trial is designed for patients with less than 3% risk of dying from open valve surgery, randomized to either transcatheter aortic valve replacement with the CoreValve device or surgical aortic valve replacement. It’s the 3rd trial for Medtronic’s TAVR offering since February, when the FDA approved the new investigational device exemption study.
The primary endpoint is all-cause mortality or disabling st...
Source: Mass Device - April 1, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Source Type: news
Recent TAVR approvals prompt changes to Direct Flow’s Salus trial
Direct Flow Medical said today that recent FDA approvals for transcatheter aortic valve replacements prompted it to make changes to the Salus trial of its own TAVR entry.
Salus, originally aimed at enrolling 1,262 patients, is now expected to enroll a little more than half that number, 648 subjects, the company said. Santa Rosa, Calif.-based Direct Flow is also adding best practices and comparisons to TAVRs that are already on the U.S. market, which include the Sapien line from market leader Edwards Lifesciences (NYSE:EW) and the Medtronic (NYSE:MDT) CoreValve device.
The 30-patient feasibility phase of for Salus in 20...
Source: Mass Device - April 28, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Wall Street Beat Direct Flow Medical Inc. Source Type: news
HRS 2016 roundup: Leadless pacers at the fore
Medtronic (NYSE:MDT) and St. Jude Medical (NYSE:STJ), aiming to distinguish their respective leadless pacemaker offerings, presented new data last week in San Francisco at the Heart Rhythm Society’s annual meeting.
St. Jude said a subset of data from the Leadless II trial showed that its Nanostim device was was successfully retrieved in 14 patients up to 3.2 years after implantation, with no serious adverse events.
“We’ve now shown that for patients requiring device upgrades or new leadless pacing options, late retrievability – even up to 3 years – is possible with the Nanostim leadless pacemak...
Source: Mass Device - May 9, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Boston Scientific Cardiac Rhythm Management HRS 2016 Medtronic St. Jude Medical Source Type: news
ReWalk inks collab deal with Harvard to develop “soft” exosuit
ReWalk Robotics (NSDQ:RWLK) said today it inked a collaborative research with Harvard’s Wyss Institute to develop a lightweight “soft suit” exoskeleton system for lower limb disabilities.
The collaboration looks to design a suit to treat stroke, multiple sclerosis and mobility limitations for the elderly as well as other applications.
Through the agreement, ReWalk will pay Harvard in quarterly installment payments to fund the research, with reports from the research being relayed between the groups on a regular basis.
ReWalk Robotics will be able to negotiate with Harvard to license new inventions create...
Source: Mass Device - May 17, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Prosthetics Harvard University ReWalk Robotics Wyss Institute Source Type: news
MassDevice.com +5 | The top 5 medtech stories for May 26, 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. Ortho Kinematics wins Health Canada nod for VMA system
Ortho Kinematics said today it won Health Canada authorization for its Vertebral Motion Analysis spinal imaging system.
The VMA system from Austin, Texas-based Ortho Kinema...
Source: Mass Device - May 26, 2016 Category: Medical Equipment Authors: MassDevice Tags: Blog Plus 5 Source Type: news
Vodafone to connect Ekso rehab exoskeletons to the IoT
Robotic exoskeletons designed for rehabilitation from Ekso Bionics (OTCBB:EKSO) are being upgraded with a connection to the “Internet of Things” from Vodafone, the companies said today.
The Ekso GT, which Vodafone said is the 1st and only exoskeleton cleared by the FDA for use with both stroke patients and spinal cord injuries, will be upgraded to connect to Vodafone’s network and global IoT to “ensure reliable communications for diagnostics and improved access to patient data.”
“The Internet of Things is enabling all types of medical devices to be connected anywhere in the world, whic...
Source: Mass Device - June 7, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Prosthetics Ekso Bionics Vodafone Group Source Type: news
MassDevice.com +5 | The top 5 medtech stories for June 15, 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. Biotronik wins CE Mark for Magmaris bioresorbable scaffold
Biotronik said today it won CE Mark for its Magmaris magnesium bioresorbable scaffold designed to treat coronary artery disease.
Data from the Biosolve-II trial of the ...
Source: Mass Device - June 15, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
MassDevice.com +5 | The top 5 medtech stories for July 8, 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. Nexstim wins CE Mark for brain therapy treatment for chronic neuropathic pain
Brain therapy system developer Nexstim said late last month it won expanded CE Mark approval in the European Union for its Navigated Brain Therapy sy...
Source: Mass Device - July 8, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
