A responsible disclosure policy tells cybersecurity researchers that, if they find a vulnerability in your device, they can tell you about it without fear of legal reprisals. FDA strongly recommends adoption of such a policy as a security practice for all manufacturers. Here’s what you need to know to be prepared for the new guidelines.
Global business services (GBS) is a service delivery framework that requires executives to think differently about their businesses, operating more effectively through a combination of outsourcing and automation to enhance customer and stakeholder satisfaction. Each organization’s approach must be customized to match the capabilities and service needs of that organization.
When it comes to designing a point-of-care device, revolutionary thinking is not as useful as evolutionary design. Incremental changes, and not paradigm shifts, are the norm.
When outsourcing and offshoring your operations, it may seem daunting to “let things go,” but redundancy wastes time and effort. Here, we will delve into the business areas to retain and those to relinquish control of, while still maintaining the high quality expected of your products.
Selecting the right injection molding partner is crucial for a successful project. The costs and timescales can be a significant part of a project budget.
Metallographic examination has become an indispensable tool in the testing, quality control, failure studies, and post-mortem analyses of implantable devices. This paper presents techniques and results for examination of titanium-based acetabular cups and Co-Cr-Mo femoral hip stems and knees.
Connectivity has evolved alongside the proliferation of the smartphone and the two are coming together to redefine how we manage our health. Considerations such as durability, battery life, security, user experience, and much more must be considered as you develop a connected medical solution, but the principal consideration for any smartphone is its principal purpose: Connectivity and communication.
Medical product marking and decoration is used for inventory control, process management and internal tracking, branding, and functionality. In many cases, lasers provide the preferred means of marking and identifying those products.
What is the best part about wearable technology products? You can wear them while they work! This also indicates, however, that your wearable device must be made of an appropriate material to be worn safely.
LifeWatch AG, a leading developer and provider of medical solutions and remote diagnostic monitoring services in the digital health market, is pleased to announce that it has received FDA clearance for its continuous Vital Signs Monitoring Service.
Continuing its track record of introducing the first magnetic resonance imaging (MRI)-safe cardiac devices to the market, Medtronic recently gained approval from the U.S. Food and Drug Administration (FDA) for cardiac resynchronization therapy defibrillators (CRT-Ds) for heart failure patients undergoing MRI scans.
The U.S. Food and Drug Administration (FDA) has cleared the first 3D-printed cranial/craniofacial plate implant to be made from titanium. Brazil-based BioArchitects’ implant uses Arcam AB’s electron beam melting (EBM) technology to combine the precision and customization of 3D printing with the light weight and high tensile strength of titanium alloys.
Velano Vascular, a medical technology company transforming and enhancing the care experience for hospitalized patients and their practitioners, announced today that the company has raised an additional $3.5 million in funding. Velano will use the proceeds from this financing, an extension of a $5 million Series A financing completed inJanuary 2015, to support the development and commercialization of the company's inpatient blood-draw technology in adult and pediatric populations.
St. Jude Medical, Inc. has announced the launch of the company’s OPTIS Mobile System in Japan and Europe. The diagnostic system is designed to couple state-of-the-art optical coherence tomography and angiography co-registration with fractional flow reserve technology into one portable system for hospitals with multiple catheterization labs.
Boston Scientific is ramping up its Watchman anti-stroke device program in anticipation of a National Coverage Determination from the Centers for Medicare & Medicaid Services (CMS). The device maker also is optimistic that it will reverse a decline in cardiac rhythm management (CRM) sales by the end of 2016, based partially on growing adoption of its Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) system.
Smith & Nephew’s (S&N) multi-year strategy to reorganize and diversify is starting to show results, said CEO Olivier Bohoun. Recent acquisitions in sports medicine and robotic surgery, as well as expanded focus in emerging markets and R&D have accelerated growth, a trend Bohoun expects to continue through 2016.
Cellnovo Group is partnering with technology company TypeZero to utilise Cellnovo’s e-connected insulin patch pump alongside its inControl AP software in an artificial pancreas program. This joint system will be in consideration for use in the International Diabetes Closed Loop Trial, which is funded by the National Institute of Health.