Drugs and Devices

Norman, Gail A. Van

doi:10.1016/j.jacbts.2016.06.003

Cited by 168 publications

(99 citation statements)

References 52 publications

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“…As these decisions are continuously evolving, some helpful resources to navigate the area include the FTC Mobile Health Apps Interactive Tooland the FDA Division of Industry and Consumer Education (DICE) [48, 33]. There are also papers that draw a comparison of European and US approval processes (e.g., mapping the EU CE Mark to the FDA framework) [49]. …”

Section: Part Ii: Security Ethical Legal and Regulatory Consideratmentioning

confidence: 99%

Digital Medicine: A Primer on Measurement

et al. 2019

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Technology is changing how we practice medicine. Sensors and wearables are getting smaller and cheaper, and algorithms are becoming powerful enough to predict medical outcomes. Yet despite rapid advances, healthcare lags behind other industries in truly putting these technologies to use. A major barrier to entry is the cross-disciplinary approach required to create such tools, requiring knowledge from many people across many fields. We aim to drive the field forward by unpacking that barrier, providing a brief introduction to core concepts and terms that define digital medicine. Specifically, we contrast “clinical research” versus routine “clinical care,” outlining the security, ethical, regulatory, and legal issues developers must consider as digital medicine products go to market. We classify types of digital measurements and how to use and validate these measures in different settings. To make this resource engaging and accessible, we have included illustrations and figures throughout that we hope readers will borrow from liberally. This primer is the first in a series that will accelerate the safe and effective advancement of the field of digital medicine.

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Section: Part Ii: Security Ethical Legal and Regulatory Consideratmentioning

confidence: 99%

Digital Medicine: A Primer on Measurement

et al. 2019

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“…the NBs issue a conformité européenne (CE) mark, and the device can be marketed in any EU member state [135]. Differently from the USA, medical devices in the EU are classified into four classes: class I, class IIa, class IIb, and class III ( Figure 11) [136].…”

Section: Regulatory Considerations and Commercialization Of 3d Printementioning

confidence: 99%

“…NBs assess and assure conformity with requirements of the relevant European commission (EU) directives. Once NBs demonstrate the device meets requirements for conformity, the NBs issue a conformité européenne (CE) mark, and the device can be marketed in any EU member state [135]. Differently from the USA, medical devices in the EU are classified into four classes: class I, class IIa, class IIb, and class III ( Figure 11) [136].…”

Section: Regulatory Considerations and Commercialization Of 3d Printementioning

confidence: 99%

Recent Applications of Three Dimensional Printing in Cardiovascular Medicine

Gardin

Ferroni

Latrémouille

et al. 2020

Cells

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Three dimensional (3D) printing, which consists in the conversion of digital images into a 3D physical model, is a promising and versatile field that, over the last decade, has experienced a rapid development in medicine. Cardiovascular medicine, in particular, is one of the fastest growing area for medical 3D printing. In this review, we firstly describe the major steps and the most common technologies used in the 3D printing process, then we present current applications of 3D printing with relevance to the cardiovascular field. The technology is more frequently used for the creation of anatomical 3D models useful for teaching, training, and procedural planning of complex surgical cases, as well as for facilitating communication with patients and their families. However, the most attractive and novel application of 3D printing in the last years is bioprinting, which holds the great potential to solve the ever-increasing crisis of organ shortage. In this review, we then present some of the 3D bioprinting strategies used for fabricating fully functional cardiovascular tissues, including myocardium, heart tissue patches, and heart valves. The implications of 3D bioprinting in drug discovery, development, and delivery systems are also briefly discussed, in terms of in vitro cardiovascular drug toxicity. Finally, we describe some applications of 3D printing in the development and testing of cardiovascular medical devices, and the current regulatory frameworks that apply to manufacturing and commercialization of 3D printed products.Cells 2020, 9, 742 2 of 33 Cells 2020, 9, 742 3 of 33 in digital modeling softwares without the need for file type conversion [16]. Several medical image segmentation softwares are available; some of these are open-source and freely accessible, while others are commercial, licensed products. From the DICOM dataset, the target anatomic geometry is identified and segmented based on properties such as contrast or brightness [17]. As a result, segmentation masks are created such that pixels with the same intensity range are grouped and converted into 3D digital models using rendering techniques. These segmented digital models are then exported out in the standard tessellation language (STL) file type, which is the industry standard for 3D objects and 3D printing software [17]. Nevertheless, STL files do not contain color information and in order to print in multiple colors, a different file format will need to be used. For example, virtual reality modeling language (VRML) and additive manufacturing file format (AMF) provide multiple color and material options [18]. Once segmentation is completed, the final 3D digital model may be further modified within computer-aided design (CAD) software. The main post-processing adjustments of the 3D model are: Repairing errors and discontinuities that sometimes arise in the image segmentation and exporting processes, smoothing of the surface of the model due to scaling errors resulting from the resolution of the original medical image, and addition of other...

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“…The regulation of anti-obesity medical devices varies by countries or group of countries. There are important differences in the regulatory processes, cost, and time to approval between the USA and Europe [15].…”

Section: Regulation and Approval/clearance Of Anti-obesity Medical Dementioning

confidence: 99%

Anti-Obesity Medical Devices

Heshmati¹

2020

Weight Management

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Obesity is a major health problem worldwide responsible for increased morbidity/mortality and high cost for the society. Management of obesity requires multidisciplinary approaches including diet, food supplement, exercise, behavior change, drug, medical device, gut microbiome manipulation, and surgery. Antiobesity medical devices are an option for subjects who have not responded to more conservative medical treatments but want an alternative to surgery. Compared to bariatric surgery, they have the advantage of being less invasive, easier to perform, and reversible. In the United States of America (USA), based on the expected weight loss, the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) categorizes anti-obesity medical devices as weightloss devices or weight-management devices. The weight-loss devices include gastric band devices, gastric space-occupying devices, and gastric emptying devices. The weight-management devices include oral removable palatal space-occupying devices and ingested transient gastric space-occupying devices. The effectiveness, safety, and cost of anti-obesity medical devices vary considerably by the type of medical device. Their use should always be combined with lifestyle changes. Considering the large market size of obesity treatment, anti-obesity medical devices can play a major role in the management of obesity.

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Drugs and Devices

Cited by 168 publications

References 52 publications

Digital Medicine: A Primer on Measurement

Digital Medicine: A Primer on Measurement

Recent Applications of Three Dimensional Printing in Cardiovascular Medicine

Anti-Obesity Medical Devices

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