The recent government shutdown will significantly impact upon FDA services and operations, especially in the heart failure (HF) and arrhythmia markets, due to the agency’s limited proactive abilities for device approvals, according to an analyst with research and consulting firm GlobalData.
Little Amelia Sloan is a pioneer: Shortly after her birth, scientists took drops of the healthy baby's blood to map her genetic code. Amelia is part of a large research project outside the nation's capital that is decoding the DNA of hundreds of infants.
EACTS Report - Prospective Randomized On-X Heart Valve Clinical Trial (PROACT) Provides Evidence of Reduced ComplicationsOctober 7, 2013 8:00 am | by Business Wire | News | Comments
On-X Life Technologies, Inc. (On-X LTI) announced today that it is highlighting the recent interim results the PROACT (Prospective Randomized On-X Anticoagulation Clinical Trial) at the European Association of Cardio-Thoracic Surgeons Meeting being held October 5-9, 2013, in Vienna, Austria.
A C.R. Bard subsidiary settled a lawsuit filed against it by VasoNova alleging that Bard and an ex-technology chief stole trade secrets to set up a new company. VasoNova makes a system that uses Doppler ultrasound and intravascular ECG to help cardiologists place catheters in the heart.
A team of experts in neurocritical care, engineering, and informatics, with the Perelman School of Medicine at the University of Pennsylvania, have devised a new way to detect which stroke patients may be at risk of a serious adverse event following a ruptured brain aneurysm.
Putnam Plastics Corporation, a leader in advanced extrusion for minimally invasive medical devices, reports increased interest in integrated catheter components made by medical device companies. These components leverage continuous manufacturing to combine sub-component processes, eliminate assembly steps and reduce manual labor, thus allowing device companies to reduce overall costs.
Royal Philips and Accenture today announced the creation of a proof-of-concept demonstration that uses a Google Glass head-mounted display for researching ways to improve the effectiveness and efficiency of performing surgical procedures. The demonstration connects Google Glass to Philips IntelliVue Solutions...
Royal Philips and Accenture today announced the creation of a proof-of-concept demonstration that uses a Google Glass™ head-mounted display for researching ways to improve the effectiveness and efficiency of performing surgical procedures. The demonstration connects Google Glass to Philips IntelliVue Solutions...
U.K.-based medical device maker Lombard Medical Technologies is doubling down on its flagship Aorfix aortic stent graft technology, dumping its non-core businesses and expanding facilities to meet demand for the device. Lombard is broadening its R&D and manufacturing facilities in Dicot, Oxfordshire...
FDA Grants Prestigious Award to Pediatric Medical Device Consortium Led by Children’s Hospital Los AngelesOctober 1, 2013 3:52 pm | by Business Wire | News | Comments
The U.S. Food and Drug Administration’s Office of Orphan Products Development has awarded a grant of up to $1.5 million over five years to the Southern California Center of Technology and Innovation in Pediatrics (CTIP), a consortium established by Children’s Hospital Los Angeles and the University of Southern California (USC) for the development of pediatric medical devices.
One day, I envision that there will be medical technology that can exceed the capabilities of the human body’s natural physiology. Should someone with such a device be prevented from playing professional sports due to the competitive advantage it provides?
Drug delivery coatings are not a new technology to the medical device industry. However, as more implantable devices are tasked with achieving a greater level of healthcare, they do offer great benefit to design engineers. This article reviews drug coating technology and looks at application areas where it has made a significant impact.
Biotronik is beginning the launch of its newly approved Ilesto line of thinner, smaller cardiac implants with the remotely monitored Ilesto DX platform, the company announced today. The Ilesto line of implants is 15% smaller and requires 29% fewer components than its predecessors, Biotronik said...
EndoCross, Ltd., which has developed a simple and cost-effective method for crossing the most challenging lesions in the percutaneous treatment of blocked coronary arteries, announced today that it has already enrolled one-third of the patients planned for the first-in-human study of its ENABLER-C Catheter System for Crossing Coronary Chronic Total Occlusions (“ENABLER 3C” study).
Intact Vascular Announces Completion of Enrollment of the Tack Optimized Balloon Angioplasty (TOBA) StudyOctober 1, 2013 11:44 am | by Business Wire | News | Comments
Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the completion of enrollment of the Tack Optimized Balloon Angioplasty (TOBA) study. The purpose of this multi-center study is to gather confirmatory data on the use of the Tack-It Endovascular System™ in the superficial femoral and popliteal arteries.
The total hospital cost of mitral valve repair surgery—from the time a patient is admitted to the hospital until release—is similar, whether performed through small port incisions using robotic equipment or via the conventional open-chest method, a Mayo Clinic study of 370 patients found.
BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced it has received approval from the Food and Drug Administration (FDA) for its Ilesto family of implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillators (ICD/CRT-D devices).
Welch Allyn, a leading medical diagnostic device company that specializes in helping clinicians improve patient outcomes, today announced the availability of a new connectivity-ready electrocardiograph device in Canada. The Welch Allyn CP 150™ offers flexible report formatting, intuitive design and functionality in addition to administering patient tests and managing information via a touch screen, color display.
Micell Technologies, Inc. has entered into an agreement with Hefei Life Science Technology Park Investment and Development Co., Ltd. (Hefei Life Science), for the clinical development, marketing and distribution of the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent...
All interested parties are welcome to join in the development of a proposed new ASTM International standard that will provide guidance on how to conduct axial, bending and torsional fatigue testing of stents. The proposed new standard, ASTM WK23330, Guide for in Vitro Axial, Bending and Torsional Durability Testing of Vascular Stents...
MIT’s new Institute for Medical Engineering and Science (IMES) is tackling some of the world’s biggest health challenges through an interdisciplinary approach that will seek new ways to diagnose and treat infectious, neurological and cardiovascular diseases.
Blood flow is routinely measured in the clinic, and laser speckle contrast imaging is one way of measuring these changes; however, this technique requires professional-grade imaging equipment, which limits its use. Now, using $90 worth of off-the-shelf commercial parts including a webcam and a laser pointer, researchers have duplicated the performance of expensive, scientific-grade LSCI instruments at a fraction of the cost.
Tracking blood flow in the laboratory is an important tool for studying ailments like migraines or strokes and designing new ways to address them. Blood flow is also routinely measured in the clinic, and laser speckle contrast imaging is one way of measuring these changes; however, this technique requires professional-grade imaging equipment, which limits its use.
Fluorescence imaging is the most widely used method for analyzing the molecular composition of biological specimens. Target molecules, when they are present, can be "tagged" with a fluorescent label and made visible. This highly sensitive technique, which is used in screening blood for cancer cells and studying biochemical reactions, is very good at detecting molecules present in extremely low concentrations.
Medical devices are increasingly dependent on software, evolving from the use of a simple two-transistor circuit for early artificial cardiac pacemakers to sophisticated modern systems supporting infusion pumps, electrocardiogram analysis, and image-guided surgery.