Just as our clothes and our shoes and our sense of fashion define who we are as individuals, a wearable device becomes an extension of our identity. As such, the appearance of a device, and its size, weight, and overall feel are just as important as the communication requirements.
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 women become more comfortable discussing sexual health with medical professionals, the market garners greater attention and receives more funding. Increases in potential patients seeking treatment will correlate with more liberal cultural environments and countries with supportive reimbursement and legislation.
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.
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.
Johnson & Johnson (J&J) is expecting above-market growth in 2017 for its medical device business, and is looking for bolt-on acquisitions to further solidify its already strong presence in the orthopedics, general surgery, and cardiovascular product segments.
Abbott and St. Jude Medical have agreed to sell a portion of their vascular closure and electrophysiology businesses to Terumo for approximately $1.12 billion, contingent on Abbott’s successful purchase of St. Jude.
Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for Peripheral Artery Disease (PAD), today announced that the company has received expanded indications from the U.S. Food and Drug Administration (FDA) recognizing the Pantheris™ Lumivascular atherectomy system as a technology that can be used for both therapeutic and diagnostic purposes.
Bigfoot Biomedical, Inc., a highly anticipated precision medicine company founded by people directly impacted by Type 1 Diabetes (T1D), recently announced a Series A investment of $35.5 million, led by entities advised by Quadrant Capital Advisors, with participation from Cormorant Asset Management, Senvest Capital, and Visionnaire Ventures.