A two-and-a-half-year-old girl is the youngest person to have received a bioengineered organ — a windpipe in this case — that was made from plastic fibers and human cells. The successful transplant of the synthetic windpipe on the girl, a Korean-Canadian named Hannah Warren, may give regenerative medicine a huge boost. The surgery, which took [...]
FDA Seeks Comments on Limiting Weather’s Effects on Medical Device Industry
February 25, 2013 By Leave a Comment
The Midwest was hit last week with a blinding snow storm that put an inch of snow on the ground every hour in some places and walloped the area with 35 mph winds. Hurricane Sandy’s storm surge last October flooded New York’s streets and subways and devastated New Jersey communities. Events like these can interrupt [...]
Veterinary Devices Get Exemption From Tax
January 11, 2013 By Leave a Comment
Medical device manufacturers are bemoaning the fact that the new health care law is requiring that they have a new tax on their products, but there’s one related manufacturer that may benefit: makers of veterinary diagnostic testing devices. Manufacturers of medical devices have been trying to prevent or delay the enactment of a 2.3% excise [...]
“Stapling” of Non-Sticky Polymers Creates Strong Bond
September 24, 2012 By Leave a Comment
Some materials, such as silicone and Teflon, are designed to be non-sticky. But some products would be improved if other materials could “stick” to them. For example, try painting silicone. After a few hours, the paint peels off because the silicone is a low surface energy polymer that has extremely low adhesive qualities. Basically, the [...]
FDA Proposes Rule on Medical Device Identifier
July 10, 2012 By Leave a Comment
The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would require manufacturers to place a unique device identifier (UDI) on medical devices, with the aim to facilitate the reporting of adverse events related to those devices so that the agency could address them more quickly, including possible recalls. The UDI would [...]
Study: Metal Stents Pose No Health Risks
April 18, 2012 By Leave a Comment
A study of coronary patients with sensitivity to metal and who have received metal stents found that those patients did not experience any adverse health risk nor any allergic reaction to these medical devices, report the authors of the research at the Mayo Clinic. The study is the first to compare clinical reactions in patients [...]
Metal Hip Implants Could Have New Testing Standards
April 6, 2012 By 4 Comments
The possibility of new testing standards for metal-on-metal hip replacement systems could have implications for plastic implants. Reuters reported on March 29 that the Food and Drug Administration (FDA), because of increasing concerns about the safety of the metal systems, will sponsor an advisory panel on June 27-28 to gather input from scientists, researchers, patients, [...]
Overhaul FDA’s Oversight of Medical Devices, Urges Consumer Reports
April 3, 2012 By 2 Comments
Consumer Reports doesn’t have much faith in the safety testing of medical devices. As described in a press release, a report issued on Wednesday, March 28 by the organization raised concerns about the regulatory oversight that goes into medical devices. It cited examples such as the Lap-Band weight-loss device, metal hip replacements, and certain cardiac devices where [...]
Senators Demand Documents From Medical Device Maker, Medtronic
July 5, 2011 By 1 Comment
The medical device company, Medtronic, now faces even more scrutiny, reports Duff Wilson in The New York Times. Two senators have expanded an investigation of the medical device maker, demanding that the company hand over records that describe millions of dollars in payments to researchers and internal correspondence with doctors who published on a controversial [...]
Medical Device and Other Biotech Companies Grow in Central VA
June 29, 2011 By Leave a Comment
Central Virginia is seeing a rise in biomedical industry endeavors, reports columnist Bryan McKenzie in The Daily Progress. More and more companies are jumping into the sector to develop medical devices and a slew of other biomedical products and health services, many of which have spun out of research done in laboratories at the University [...]
