On Friday, September 20, the final Unique Device Identification (UDI) rule was issued by the Food and Drug Administration in conjunction with the 2013 UDI Conference in Baltimore, Maryland. Tom Beatty, Sr. Principal, UDI Compliance at QDevice, the medical device consulting division of QPharma, was in attendance for the announcement.
Whether it's the Ebola virus or Sarin and Ricin, a key to responding to chemical or biological attacks is having effective antidotes at the ready. To accelerate the development of new therapies, Wake Forest Baptist Medical Center's Institute for Regenerative Medicine is leading a unique $24 million federally funded project to develop a "body on a chip" that will be used to develop these countermeasures.
TVA Medical's Minimally Invasive System for Hemodialysis Access Demonstrates Success in Clinical StudySeptember 26, 2013 1:51 pm | by PR Newswire | News | Comments
Preliminary data presented last week at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual scientific meeting demonstrated that TVA Medical's FLEX System can create vascular access for hemodialysis patients without traditional open surgery.
World First: Sernova's Cell Pouch Shown to Provide a Safe Environment for Therapeutic Insulin Producing Islets in Humans with Type 1 DiabetesSeptember 26, 2013 1:03 pm | by The Associated Press | News | Comments
Sernova Corp today announced that Dr. James Shapiro, principal investigator of the clinical study, presented encouraging safety and biocompatibility results for the Cell Pouch and following islet transplant, proof of islet cell survival and the presence of insulin in the first two patients of an up to 20 patient study.
On this episode of The Pulse, brought to you by MDT TV, we're treating wounds with a self-healing polymer, implanting a cure for sleep apnea, printing objects in 3D for the blind, and monitoring vital signs with a shirt. This episode feature: Scientists have created the world's first self-healing polymer that can repair itself without any intervention, offering potential applications in wound care.
A surge of mobile apps related to dermatology has allowed scores of smart phone users to track and diagnose a wide range of skin diseases but doctors are urging caution, according to a study published today in the Journal of the American Medical Association.
University of Adelaide researchers have developed a process for turning waste plastic bags into a high-tech nanomaterial. The innovative nanotechnology uses non-biodegradable plastic grocery bags to make 'carbon nanotube membranes' - highly sophisticated and expensive materials...
NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today that the first surgeries were performed in Japan using the Precept® posterior fixation system.
A California state court ruled out a series of motions seeking to dismiss a lawsuit filed over bone proteins made by Stryker and Medtronic, ruling that federal law does not preempt the case from going forward. April Cabana sued the medical device companies for alleged off-label promotion of the bone growth products...
The key to protecting PHI data is education, execution, and continuous verification. The first thing is to understand your obligation as a custodian of this sensitive data. This is best done through formal HIPAA/HIPAA-HITECH training to understand the regulation.
Two-thirds of health IT executives in the U.S. believe the use of mobile technology will substantially or dramatically impact the delivery of healthcare in the future. But how will the form and function of this technology be defined? How can the designers of technology ensure the best fit with the needs of the healthcare professionals who will make use of it?
Shares of medical device makers rose Wednesday after Stryker Corp. agreed to buy robotic surgery system maker Mako Surgical for $1.41 billion. Stryker will pay $30 per share for Mako, an 86 percent premium based on the stock's latest closing price.
MiMedx Group, Inc., an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, commented today on various recent media reports concerning certain of the Company's tissue products and the amniotic tissue industry.
A lawsuit headed to trial in New Mexico accuses a doctor, hospital and an international biomedical firm of teaming up to implant unneeded pacemakers and other devices in patients to boost profits. Tommy and Barbara Sowards are suing for damages after they say the doctor implanted an unneeded...
ARGO Medical Technologies has partnered with innovative robotics experts YASKAWA Electric Corporation as it continues the global expansion of its ReWalk exoskeleton device which enables individuals with lower limb disabilities such as paraplegia to walk.