I spoke with Craig Thompson, MD, SVP/CMO of Boston Scientific’s Interventional Cardiology unit, about TAVR costs, benefits, and market drivers, as well as Boston Scientific’s Lotus valve system.
Factors driving the adoption of human factors engineering include market demand for intuitive products, the world’s growing, aging population, mass customization of products, and greater patient engagement. User preference now is almost as important as clinical efficacy, as customer feedback and performance metrics affect how hospitals and other providers are compensated by insurance companies and Medicare.
After countless hours putting together your 510(k) submission, the last thing you expect is to get a rejection letter from the FDA. However the odds are against you — between January and June of 2015, 69% of 510(k) applications were rejected their first time. Here are four reasons why your submission might get rejected, and tips to avoid making these mistakes.
As part of the outsourcing and offshoring community, we collectively take a lot from local communities, and often forget what enables us to reap such financial and strategic benefits. Giving back to the communities in which we live and work should be a cornerstone of the outsourcing/offshoring relationship.
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.
FDA has approved Abbott’s Freestyle Libre Pro System for professional continuous glucose monitoring (CGM), which provides clinicians with 14 days’ worth of patient data so they can make more informed clinical decisions regarding diabetes management.
Medtronic says the U.S. Food and Drug Administration (FDA) has cleared the company's TrailBlazer angled support catheter, which is used in endovascular procedures to support a guidewire and deliver solutions and diagnostic agents as part of the treatment of peripheral artery disease (PAD).
Galway, Ireland further solidifies its position as a global center for medical technology as it opens CÚRAM, the Centre for Research in Medical Devices, based at NUI Galway. The facility will provide Irish and foreign scientists and entrepreneurs support in developing basic research ideas — in glycoscience, biomaterials science, regenerative medicine and tissue engineering, drug delivery, and medical device design — into commercially viable clinical applications.
Boston Scientific has announced a $210 million deal to acquire EndoChoice Holdings, an Atlanta-based medtech specializing in endoscopic imaging systems, single-use devices, and infection control products.
GE Healthcare is earmarking $50 million to fund five.eight, its first healthcare accelerator, which will support startups that develop promising, low-cost medtech technologies specifically designed for emerging markets.
BrainScope — a medtech specializing in traumatic brain injury (TBI) diagnostic technology that is backed by the U.S. Department of Defense (DOD)— has announced FDA clearance for Ahead 300, a hand-held medical device capable of objectively assessing the likelihood of TBI.
Medtronic plc, the global leader in medical technology, recently announced that Sugar.IQ with Watson, the first-of-its-kind cognitive app that helps detect important patterns and trends for people with diabetes, is now in live use for the first time.
The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) announced recently its top ten regulatory science priorities for 2017. As they were in 2016, "Big Data" and medical device cybersecurity remain as focus areas, with precision medicine and clinical trial design joining the list of priorities for next year.