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Implanted Blood Access Devices for Hemodialysis - Draft Guidance for Industry and Food and Drug Administration StaffJune 27, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments
This draft guidance document provides draft recommendations for complying with special controls being proposed to support reclassification of the Implanted Blood Access Devices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.
BIOTRONIK has announced the European market launch of its Ilesto 7 Series today. Ilesto 7 is the world’s first DF4 ICD/CRT series approved for MRI, and includes one of the world’s smallest ICDs while also offering the greatest longevity—up to 11.5 years for the single chamber ICD.
CryoLife, Inc. (NYSE: CRY), a leading tissue processing and medical device Company focused on cardiac and vascular surgery, announced today that it has received conditional approval of its Investigational Device Exemption (IDE) for PerClot from the United States Food and Drug Administration (FDA).
Covidien (NYSE:COV), a leading global provider of healthcare products, today announced that the final results of the PUFs (Pipeline for Uncoilable or Failed Aneurysms) clinical study of its Pipeline™ embolization device have been published in the June issue of Radiology. Radiology is the official peer-reviewed medical journal of the Radiological Society of North America.
A more accurate and reliable stroke prediction model has been developed to help physicians decide whether to start blood-thinning treatment for patients with atrial fibrillation, as described in the current online issue of the Journal of the American Heart Association.
Sorin Group Announces First U.S. Implant of PARADYM RF SonR CRT-D for RESPOND CRT IDE Clinical TrialJune 20, 2013 10:00 am | by Business Wire | News | Comments
Sorin Group (MIL:SRN), a global medical device company and leader in the treatment of cardiovascular diseases, announces the first U.S. implant of its PARADYM SonR CRT System for the RESPOND CRT IDE Clinical Trial. Dr. B. A. Smith, Electrophysiologist, Piedmont Heart Institute, Atlanta, GA, performed the procedure on May 30.
Researchers at MIT’s Computer Science and Artificial Intelligence Laboratory have developed a new algorithm that can accurately measure the heart rates of people depicted in ordinary digital video by analyzing imperceptibly small head movements that accompany the rush of blood caused by the heart’s contractions.
Covidien (NYSE: COV), a leading global provider of healthcare products, has announced that an independent study conducted by the University of Edinburgh has successfully demonstrated the effectiveness of Covidien’s Kendall SCD™ system with Vascular Refill Detection Technology on immobile stroke patients.
Systems such as a beating heart or a power grid that depend on the synchronized movement of their parts could fall prey to an invisible and chaotic tug-of-war known as a "chimera."
Codman Neuro, part of DePuy Synthes Companies of Johnson & Johnson, has obtained CE marking for REVIVE SE, a next-generation self-expanding clot removal device for use in treating acute ischemic stroke.