This article demonstrates how to use statistical tolerance limits, which use the confidence level (how sure we are) and reliability value (population value) to determine appropriate statistically valid sample sizes for process validation.
It is time to discard the old thinking of “drug and/or device,” and to begin focusing on the goal of developing complete therapeutic systems.
A VAB presents the results of a systematic review delineating the potential clinical and economic benefits of a technology, product, procedure or service. It is created with the end user in mind, as there may be multiple stakeholders for whom the value of a technology may differ.
A home visit presents a unique opportunity to discover how a patient or caregiver manages medications, supplies, and everyday device use.
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.
Baxter has continued its year-long momentum with 3 percent growth in the company’s 2016 third quarter, which included double-digit growth in hospital products sales.
Edwards Lifesciences is optimistic on the long-term growth prospects of transcatheter aortic valve replacement (TAVR), even though sales of the company's Sapien heart valves during the third quarter of 2016 were lower than expected.
The FDA has approved an investigational device exemption (IDE) clinical trial to investigate a left ventricular assist device (LVAD) system small enough for use in infants and children. The Jarvik 15mm device, introduced earlier this year by Jarvik Heart, is adjustable for long-term use in children as they grow and wait for a suitable heart transplant.
An investigation conducted by the U.S. Food and Drug Administration (FDA) revealed that multiple hospitals have inadequate compliance with medical device reporting requirements. Believing that the issue could be widespread, the agency has scheduled a public workshop to seek advice on improving postmarket, hospital-based surveillance mechanisms.
Medtronic plc recently announced the U.S. Food and Drug Administration (FDA) approval and U.S. launch of the CoreValve Evolut R 34 mm valve-the largest sized transcatheter aortic valve replacement (TAVR) system available in the U.S. The new Evolut R 34 mm valve is approved for severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26-30 mm.
Royal Philips' successful pivot into health technology continues with third quarter sales surging 14 percent to €5.9 billion ($6.4B), primarily driven by 5 percent comparable sales growth and an 8 percent hike in order intake in its HealthTech portfolio.
GE Healthcare continues to grow in its third quarter of 2016, and the company posted double-digit profit growth for its healthcare business despite substantial challenges in other segments, principally oil and gas. Senior executives attribute 8 percent growth in overall healthcare orders to strength in imaging and continued momentum in the Chinese market.
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.