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...
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.
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Implanted Blood Access Devices for Hemodialysis - Draft Guidance for Industry and Food and Drug Administration StaffJune 27, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments
This draft guidance document provides draft recommendations for complying with special controls being proposed to support reclassification of the Implanted Blood Access Devices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...
In June 2013, Medtronic, Inc. (NYSE: MDT) initiated four medical device notifications to customers worldwide about the SynchroMed® Implantable Infusion System. These notifications provide clinicians with information to help identify and manage issues that impact the safe and reliable delivery of therapy using the SynchroMed Implantable Infusion System.
In November 2012 and February 2013, Andrew Johnson underwent a surgical procedure, Deep Brain Stimulation surgery, to help control his motor symptoms. This video represents his experience of how DBS has helped him. He is using a device from Medtronic.
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.
Evergreen Medical Technologies Launches Integrated Lead to Pulse Generator Interconnect System for Implantable NeurostimulatorsJune 21, 2013 2:46 pm | by Business Wire | RMS, Bal Seal Engineering, Inc. | News | Comments
Evergreen Medical Technologies has launched the Encompass Lead-Interconnect System, the first pretested integrated lead-interconnect system designed for implantable neurostimulator pulse generator (IPG) devices. The Encompass, enabled by Bal Seal Engineering’s SYGNUS® implantable contact system and rms Company’s premolded 16-channel header technology, saves development time and costs for neurostimulation device companies.
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.
The Food and Drug Administration said last Friday it approved a next-generation silicone breast implant from Johnson & Johnson unit Mentor. The company's MemoryShape breast implant uses a cross-linking gel design that the FDA says is firmer than previous implants.
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.
Product development firm Cambridge Consultants has announced that it is working with the Institute of Metabolic Science (IMS) at Addenbrooke’s Hospital in Cambridge, UK on groundbreaking research to create an artificial pancreas.
Much like other medical technology, implants are adapting to a post-depression economy brimming with new materials, new ideas, and ambitious plans for the future. The result is a focus on designing safer, more bio-compatible products for local markets.
3D printing can now be used to print lithium-ion microbatteries the size of a grain of sand. The printed microbatteries could supply electricity to tiny devices in fields from medicine to communications, including many that have lingered on lab benches for lack of a battery small enough to fit the device, yet provide enough stored energy to power them.
Spinal implant manufacturer Globus Medical may have to pay $16 million after a jury decided that three of its products infringed on the patents held by DePuy Synthes Products LLC, a unit of Johnson & Johnson Inc.
A Boston hospital is starting the world's first hand transplant program for children, and doctors say it won't be long until face transplants and other radical operations to improve appearance and quality of life are offered to kids, too.
Growing lungs and other organs for transplant is still in the future, but scientists are working toward that goal. In North Carolina, a 3-D printer builds prototype kidneys. In several labs, scientists study how to build on the internal scaffolding of hearts, lungs, livers and kidneys of people and pigs to make custom-made implants.
A new formulation of synthetic, biochemically absorbable polymers is creating opportunities in the medical device and pharmaceutical fields. These “bioabsorbable polymers” are materials designed to dissolve into compounds that the body can safely absorb or eliminate.
On this episode of The Pulse, rewired nerves from amputated limbs allow for prosthetic control with existing muscles, a bioengineered blood vessel is transplanted, diabetes is diagnosed through breath analysis alone, and a new technology is paving the way for low-cost electronic devices that work in direct contact with living tissue inside the body.
Micell Technologies, Inc. received CE (Conformite Europeenne) Mark approval for its MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES®) introducing a thin-strut stent that features elimination of the coating from the stent in 45-60 days and the complete absorption of the polymer coating within 90 days.
Two new studies by researchers at Hospital for Special Surgery have shed light on joint replacement outcomes in patients with rheumatoid arthritis (RA). One study overturns the common belief that RA patients have worse outcomes after a total knee replacement (TKR) than patients who undergo the operation for osteoarthritis.
Twenty Patients Implanted in Functional Neuromodulation’s ADvance Study of Deep Brain Stimulation for Alzheimer’s DiseaseJune 12, 2013 9:07 am | by Business Wire | News | Comments
Functional Neuromodulation Ltd.’s ADvance Study has implanted 20 mild Alzheimer’s patients with deep brain stimulation (DBS) systems, and the U.S. Food and Drug Administration has approved expansion of the study from 20 to 30 U.S. patients in combination with 20 subjects approved in Canada.
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced U.S. Food and Drug Administration (FDA) approval of its next-generation Ellipse™ and SJM Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The new devices are designed to lower the risk of lead abrasion and to ensure high-voltage therapy delivery.
New technology under development at The Ohio State University is paving the way for low-cost electronic devices that work in direct contact with living tissue inside the body. The first planned use of the technology is a sensor that will detect the very early stages of organ transplant rejection.