Remarkable advances in genomics technologies bring the promise of extraordinary changes in healthcare — and some of those changes are arriving now. What’s unfolding are nine trends that we think will shape the life science markets in this accelerating genomics revolution. First, some background on how we got here.
A home visit presents a unique opportunity to discover how a patient or caregiver manages medications, supplies, and everyday device use.
Most of FDA’s senior leadership overseeing device regulation has been replaced since 2002, shifting an organization that was perceived as unresponsive and reclusive to one that strives to be interactive and front-facing.
According to a 2014 PwC survey, one-third of all manufacturers are adopting 3D printing. The FDA has approved or cleared more than 85 devices made using 3D printers. Where and how is 3D printing changing the medical device industry, and what does the future hold?
As the FDA’s next deadline for the unique device identification (UDI) of Class II devices draws closer, medical device manufacturing companies are looking to further their UDI implementation, whether they are well on their way to success or they haven’t even started. Barcoding, or identifying products via GS1 regulatory standards, is essential for companies wishing to be up to date on UDI implementation. Unfortunately, companies may be delaying UDI implementation because they view the new regulations as something an organization can address quickly. This is not the case. This article discusses the importance of viewing UDI implementation as process that encompasses the entire company rather than just as a “quick fix.”
The industry must be able to demonstrate that it has been able to use the tax suspension to innovate and grow in order to avoid the tax’s reinstatement. The ability to show results will be paramount, creating a need for more efficient online reporting.
Radio frequency (RF) ablation uses RF energy to ablate or destroy unwanted tissues. When delivered via a catheter, it offers a minimally invasive treatment for a wide variety of conditions, including atrial fibrillation (AF). These systems typically include a peristaltic pump to provide cooling or temperature control, and this pump must be able to produce and control the high pressures (up to 130 psi) required in this application.
Shifts in healthcare have essentially changed suppliers’ role in the industry – especially when it comes to infection prevention. And, they’ve greatly impacted how both providers and suppliers think about the use of antimicrobials.
Labels often are an afterthought, because they don’t directly affect the capabilities of a medical device. However, they certainly affect the functionality of the device and users’ ability to effectively utilize all of its features. Consider these factors — and their importance — as you design your medical device overlay or inventory stickers.
Phillips-Medisize Corporation, is once again a sponsor and will present during a panel discussion at the upcoming Partnership Opportunities in Drug Delivery (PODD) conference in Boston, MA.
The U.S. Food and Drug Administration (FDA) is asking scientists and technology experts from the private sector to provide the agency with valuable input on emerging issues and cross-cutting scientific advances that could impact regulation within five to 10 years.
Optical fibers designed using biocompatible hydrogel could play a role in next-generation, flexible biosensors, according to scientists at Harvard University and MIT. By tracking the quality of light shining through the stretchy fibers, researchers could use the technology in implantable or wearable devices to monitor muscle mobility, tumor growth, or inflammation over time.
Abbott CEO Miles White says the deal to acquire St. Jude Medical is on track to close by the end the year, as expected. The planned purchase of point-of-care diagnostics firm Alere, however, needs to comply with certain regulatory requirements, which Abbott is actively pursuing.
According to researchers, the citrus-based polymer material used has natural antioxidant properties, and could potentially be loaded with anti-coagulation drugs to minimize complications.
Third quarter profit for Intuitive Surgical surged 26 percent on increased procedures and sales of its da Vinci surgical platform, which the company is looking to expand by bringing in new technologies through a combination of in-house R&D, partnerships, licensing, and tuck-in acquisitions.
An investigative report by the Star Tribune revealed that FDA accepted “retrospective summary reports” that cover hundreds of thousands of incidents, years after they occurred. FDA argued that excessive paperwork would “clog” the reporting system and be of little use to the public.
JDRF and the University of Toronto are pleased to announce a $400,000 (USD) research grant to support the development of a skin [transdermal] patch to prevent hypoglycemia - a common, potentially life-threatening, risk for people living with type 1 diabetes (T1D).