As Parker sees it, the three biggest obstacles to [design] success for patient care products, such as oxygen concentrators and ventilators, are portability, battery life, and reliability. To make home care products more portable, Parker has reduced the size of some valves up to 75%.
As more therapies are able to indicate implantable devices for treatment, incorporating drug delivery into them can be a significant additional benefit. Even when drug delivery is the primary function, implantable devices can be preferable. This article reviews some representative applications that device designers can leverage in developing new products for the implantable drug delivery market.
ZOLL Medical Corporation has purchased the assets of CoAxia, an early revenue stage medical device company that provides catheter-based perfusion augmentation therapies to improve outcomes for patients with cerebral ischemia resulting from vasospasm, following subarachnoid hemorrhage.
DNA fragments in your blood may someday help doctors quickly learn if chest pain means you have narrowed heart arteries, according to a new study published in the American Heart Association journal Arteriosclerosis, Thrombosis, and Vascular Biology.
Thoratec has acquired the DuraHeart II ventricular assist system from Terumo Corporation for an upfront cash payment of $13 million and potential future milestone payments, based on regulatory approvals and product sales, of up to $43.5 million.
Is it possible, that in 2-3 years Brits, Germans, Scandinavians, and Russians will undergo cancer treatment, orthopaedic, or cardiac surgery procedures in Polish medical facilities more often? Treat teeth and get implants in dental clinics; take a cure in Polish sanatoriums?
In a move that would significantly boost its capabilities in the fast-growing market for advanced electrophysiology procedures, Boston Scientific has entered into a definitive agreement to acquire Bard EP, the electrophysiology business of C.R. Bard, for $275 million in cash.
ZOLL Medical Corporation, a manufacturer of medical devices and related software solutions, announced today that survival from one of the leading causes of death in the United States, out-of-hospital cardiac arrest, more than doubled from 26% to 56% when paramedics in Mesa, Arizona utilized ZOLL’s CPR feedback technology in combination with scenario-based training.
Boston Scientific Corporation is launching a new family of pacemakers in Europe. These pacemakers monitor respiration, adjust pacing accordingly, and support insight into the patient’s overall heart failure status. Comprising of the INLIVEN cardiac resynchronization therapy pacemaker...
Engineers from Queen Mary, University of London have developed the most precise computer simulation of how red blood cells might travel around the body to help doctors treat people with serious circulatory problems. Understanding how damaged red blood cells might interact with each other or their neighboring cells could be useful in realizing blood flow in patients who are diabetic or have had surgery to address circulation complications.
On this episode of The Pulse, a major step toward an artificial pancreas, detecting disease from just one drop blood, creating mature human cardiac patches from human heart cells, and a smart sock that helps runners improve their technique and prevent injuries.
People who have a traumatic brain injury (TBI) may be more likely to have a future stroke, according to research that appears in the June 26, 2013, online issue of Neurology®, the medical journal of the American Academy of Neurology.
The antibacterial effects of silver are well established. Now, researchers at Yonsei University in Seoul, Republic of Korea, have developed a technique to coat glass with a layer of silver ions that can prevent growth of pathogenic bacteria including Escherichia coli, Salmonella typhimurium and Campylobacter jejuni. The technology could be used to protect medical equipment.
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) and launch of the Accent MRI ™ Pacemaker and the Tendril MRI ™ lead.
Implanted Blood Access Devices for Hemodialysis - Draft Guidance for Industry and Food and Drug Administration StaffJune 27, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments
This draft guidance document provides draft recommendations for complying with special controls being proposed to support reclassification of the Implanted Blood Access Devices for Hemodialysis into class II (special controls). The device, as proposed...
CEA-Leti and nine partners in the NEPHRON+ project are developing an artificial kidney that would provide a major improvement in treating patients with chronic kidney failure. The goal is a next-generation, integrated system that allows real-time, continuous, multiparametric monitoring of the patient and the device via sensors developed by Leti and its partners.
With the 3rd Edition of IEC 60601-1 impacting U.S. design engineers in June, it is critical they are aware of the implications to their medical device designs. For home healthcare devices, there is a collateral standard that will have a specific effect. This article focuses in on powering these products and the items in the standard of significance for that aspect.
Middle Peak Medical, a development-stage medical device company that will commercialize a novel technology for treating mitral valve disease, has raised $8.5M in a Series A financing. The round was co-led by healthcare investment specialists Wellington Partners and Seventure Partners, along with seed investor High-Tech Gründerfonds Management GmbH (HTGF).
Qardio Unveils Daily-Wear, Wireless Devices for Continuous Health Monitoring by Consumers & Their PhysiciansJune 26, 2013 7:00 am | by The Associated Press | News | Comments
Qardio, a healthcare technology company, today unveils two revolutionary, cardiovascular monitoring devices. QardioCore and QardioArm are elegantly designed for effortless daily-wear, continuous monitoring by those with, or at risk of developing, cardiovascular conditions and sharing of data...
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis. A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.
Aethlon Medical, Inc. (OTCQB: AEMD), announced today that the United States Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) that allows the Company to initiate human feasibility studies of the Aethlon Hemopurifier@ in the United States. The...
A new method of maturing human heart cells that simulates the natural growth environment of heart cells while applying electrical pulses to mimic the heart rate of fetal humans has led researchers at the University of Toronto to an electrifying step forward for cardiac research.
Medical electronic devices are no longer a trend; they are the reality of today’s healthcare environment. Seemingly, the number of powered medical devices far exceeds their non-powered counterparts. Even devices that had traditionally not been powered, such as the stethoscope, are now either being replaced by more effective electronic devices or being updated with electronics to function more efficiently and, more simply, better.
Lombard Medical Technologies PLC (AIM: LMT), the specialist medical technology company focused on innovative vascular products, today announces that the Aorflex™ delivery system has been approved for commercial use in the US by the Food and Drug Administration (“FDA”).
The brain-preserving cooling treatment known as therapeutic hypothermia is rarely being used in patients who suffer cardiac arrest while in the hospital, despite its proven potential to improve survival and neurological function, researchers from the Perelman School of Medicine at the University of Pennsylvania report in the June issue of Critical Care Medicine.