Any device that uses any kind of code — in other words, practically all modern medical devices more complicated than a basic scalpel — can potentially be hacked or otherwise compromised, even if they are not directly connected to the internet.
In this article — part one of a two-part series — we will examine the history of companion diagnostic approvals by FDA. Through this process, trends can be identified to suggest better approaches to optimize review times.
The dental medical device industry is shifting due to changes in regulatory factors, demographics, and economics. These shifts ripple outward to affect the patients, the dentists, and ultimately the manufacturers of dental medical devices, in a way that is causing major changes in the competitive landscape.
Cancer research receives a huge share of global R&D spending, driving lots of innovation in therapies and changing the landscape of the remission and recovery phases, in particular. However, the availability of drugs on self-administration device platforms is one element of cancer care that is not aligned with a non-clinical, long-term care model. Herein lies a great opportunity for medical device manufacturers.
In the race to bring innovative products to market, ensuring a seamless transition from design to manufacturing is critical. Yet, in today’s marketplace, design and manufacturing engineers alike are faced with many new challenges.
Looking at the rising trend towards self-administration therapies, injectable drug delivery devices such as pen injectors, autoinjectors and needle free injectors show a significant growth potential in the near future.
The orthopedic implant industry is in a continual state of development, witnessing an explosion of novel materials, designs, and applications. This process is, however, often laced with challenges and articulating joints can present the greatest number of these. By Aia Malik, Lucideon, and Chris Pickles, Ph.D.
Fused Deposition Modeling™ (FDM® ) can be used to produce an array of medical devices; however, for such devices to be practical, they must be manufactured using sterilizable materials. By David Espalin, Francisco Medina, Mireya Perez, and Ryan Wicker, The University of Texas at El Paso; and Terry Hoppe and Rob Winker, Stratasys
Manufacturing Execution System (MES) solutions have the potential to generate efficiencies, improve productivity, and simplify compliance within the medical device manufacturing industry. Used to manage production activities, this class of software typically provides the ability to schedule activity, deliver instructions to operators, synchronize manual activities with automated processes, and integrate with manufacturing computer systems to enable quality control, deviation management and effective enterprise resource planning (ERP), equipment management, and the documenting of floor activities for monitoring and reporting purposes.
Nokia has announced a partnership with the Helsinki University Hospital (HUS) in Finland, and the collaboration’s first project will focus on remote monitoring solutions for patients suffering from neurological conditions. This move reflects Nokia’s desire to expand past consumer fitness wearables and into clinical solutions, according to senior leadership.
Microsoft and France-based Median Technologies are teaming up to extract biomarkers from medical images using advanced algorithms, with the aim to help oncologists diagnose and treat cancer patients in the United States, Europe, and Asia.
Centric Medical, a division of Life Spine, Inc. has announced that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the Subtalar Arthroereisis Implant System for treating hyperpronation of the foot and stabilization of the subtalar joint.
The FDA has released a final guidance outlining the agency’s thoughts on leveraging data obtained during clinical trials with adults to secure device labeling for pediatric indications. The agency hopes that this new approach will “streamline” the approval process for pediatric devices and improve children’s access to important life-saving technology.
IBM is forming a “Watson Health medical imaging collaborative” with sixteen leading health systems, academic medical centers, ambulatory radiology providers, and imaging technology companies to help clinicians utilize IBM Watson cognitive imaging analysis in diagnosing increasingly prevalent disorders, such as cancer, diabetes, and heart disease.
St. Jude Medical, Inc., a global medical device company, announced CE Mark approval and launch of SyncAV CRT software, designed to build upon the company’s first-to-market MultiPoint Pacing technology and further optimize St. Jude Medical’s comprehensive cardiac resynchronization therapy (CRT) portfolio. MultiPoint Pacing technology with the SyncAV CRT software algorithm is designed to address and effectively treat heart failure patients who are not responsive to other pacing options.
Philips is expanding its foothold in digital pathology with the acquisition of Path XL, a digital imaging analysis (DIA) and software firm based in Ireland, as well as a licensing agreement with Visiopharm, a software company developing algorithms for breast cancer. Philips CEO Frans van Houten commented that he expects Philips digital pathology business to double year over year.
The U.S. Food and Drug Administration (FDA) has announced the issuance of Emergency Use Authorizations (EUAs) for two in vitro diagnostic (IVD) devices for detection of Zika virus. The EUAs were based on prior determination by the Secretary of Health and Human Services (HHS) that the present Zika outbreaks in the Americas constitute a public health emergency, and pose a threat to U.S. national security or the health and security of U.S. citizens.