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.
St. Jude Medical, Inc., a global medical device company, today announced CE Mark approval of its next-generation quadripolar device, the Quadra Assura MP ™ cardiac resynchronization therapy defibrillator (CRT-D). Built upon the company’s first-to-market Quadripolar Pacing System, the Quadra Assura MP CRT-D features MultiPoint ™ Pacing (MPP) technology that enables physicians to pace multiple locations on the left side of the heart.
I have one family member in nursing school and one in medical school, which means I sometimes find myself on the cold end of a stethoscope while they check my radial pulse, blood pressure, respiratory rate, and whatever else they need to practice. As a result, I’ve developed a somewhat obsessive, but healthy habit of tracking my blood pressure.
Design and development of a medical device is an exacting process, to say the least, and it assumes even more complexity because it almost always extends across years that encompass multiple iterations of the device. As a result, small things that were satisfactory in the prototype and first production run can grow to be problems that must be solved as production volume rises.
The conference program for MEDICA 2013, International Trade Fair with Congress – World Forum for Medicine, is undergoing a full re-launch. The content repositioning for MEDICA 2013 (to be held from November 20 – 23, 2103 in Düsseldorf, Germany) is designed to closely fit the program of the trade fair’s topics relevant to medical equipment users and to expand the international side of the program.