Heart Test Labs Completes Regulatory Submission for both FDA 510(k) and CE Mark

Heart Test

October 4, 2016 – Westlake, TX — Heart Test Laboratories, Inc., is pleased to announce that it has submitted its 510(K) application to the Food and Drug Administration (FDA) and a CE Mark certification submission to the British Standards Institute (BSI) group for its MyoVista electrocardiographic device. FDA clearance is required for Heart Test Labs…

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Expert Insights: An Interview with Paula Rutledge, Legacy Medsearch

Legacy MedSearch

Paula Rutledge is the president of Legacy MedSearch, a retained recruitment firm specializing exclusively in the medical device industry. Since 2005, Paula and her team have successfully matched employers and candidates across the clinical and technology spectrum, from orthopedics, spine, neurology, cardiology and ophthalmology to drug delivery, haptic robotics, healthcare IT and many others. We…

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Damaging Effects of Strokes on Blood-Spinal Cord Barrier

blood-spinal cord barrier

Stroke’s long-term effects on blood-spinal cord barrier can lead to ‘an increasingly toxic environment’ in spinal cord and ‘significant input on disease pathology’. A team of researchers at the University of South Florida investigating the short and long-term effects of ischemic stroke in a rodent model has found that stroke can cause long-term damage to…

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Artificial Blood Vessels That Can Grow In the Body

artificial blood vessels

In a groundbreaking new study led by University of Minnesota biomedical engineers, artificial blood vessels bioengineered in the lab and implanted in young lambs are capable of growth within the recipient. If confirmed in humans, these new vessel grafts would prevent the need for repeated surgeries in some children with congenital heart defects. The study…

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Verb Surgical Unveils Vision of Next-Gen Robotic Surgery

Verb Surgical

Verb Surgical is working on what it sees as “Surgery 4.0”: the next iteration of surgery that incorporates robotics, advanced visualization, machine learning, data analytics and connectivity. It expects that its technology could translate into real access for billions globally who currently don’t have access to surgery by lowering costs and reducing the training threshold.…

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New Catheter Lets Doctors See Inside Arteries for First Time

arteries

Removing plaque from clogged arteries is a common procedure that can save and improve lives. This treatment approach was recently made even safer and more effective with a new, high-tech catheter that allows cardiologists to see inside the arteries for the first time, cutting out only the diseased tissue. Interventional cardiologists at Sulpizio Cardiovascular Center…

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BrainScope Announces FDA Clearance for Smartphone Device Diagnosing TBI

BrainScope

BrainScope — a medtech specializing in traumatic brain injury (TBI) diagnostic technology that is backed by the U.S. Department of Defense (DOD)— has announced FDA clearance for Ahead 300, a hand-held medical device capable of objectively assessing the likelihood of TBI. The technology leverages advanced algorithms and machine learning to diagnose the “full spectrum” of…

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3D Print-On-Demand Bone Could Quickly Mend Major Injuries 

bone

If you shatter a bone in the future, a 3D printer and some special ink could be your best medicine. Researchers have created what they call “hyperelastic bone” that can be manufactured on demand and works almost as well as the real thing, at least in monkeys and rats. Though not ready to be implanted…

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Parasitic Heart Disease Threat Brings New Health Concerns to The U.S. 

health concerns

The U.S. is a true melting pot. In 2014 alone, more than one million immigrants gained legal permanent residence within its borders. But with that distinction comes an ever-changing set of health concerns that physicians must help treat and manage. The latest, according to a recent article in the journal Circulation, is Chagas heart disease.…

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The First Baby With 3 Genetic Parents is Created

first baby

A doctor who treats infertility in New York City says he has helped a couple have the first baby purposefully created with DNA from three different adults. John Zhang of the New Hope Fertility Center in Manhattan traveled to Mexico earlier this year to perform a procedure for a couple from Jordan that enabled them…

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