Semiconductor-based Biosensing Technology for in vitro Diagnostic Device

2017 ◽  
Vol 137 (10) ◽  
pp. 296-300
Author(s):  
Toshiya Sakata
Keyword(s):  
Diagnostic Device

scholarly journals Regulatory hurdles in bringing an in vitro diagnostic device to market

1996 ◽  
Vol 42 (9) ◽  
pp. 1556-1557 ◽  
Author(s):  
K M Smith ◽  
J A Kates
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
New Products ◽  
New Product ◽  
Diagnostic Device ◽  
Regulatory Strategy ◽  
The Us ◽  
In Vitro Diagnostic ◽  
Medical Device Regulation

Abstract We discuss the hurdles that developers and manufacturers of in vitro diagnostic devices face in obtaining regulatory approval to market their products in the US. A thorough understanding of medical device regulation and the early planning of a clinical and regulatory strategy are imperative in assuring successful and timely launches of new products. Finally, it is critical for manufacturers to establish a working partnership with the Food and Drug Administration to expedite their new product applications.

scholarly journals Nondestructive Assessment of Articular Cartilage Electromechanical Properties after Osteochondral Autologous and Allogeneic Transplantation in a Goat Model

Cartilage ◽  
2018 ◽  
Vol 11 (3) ◽  
pp. 348-357
Author(s):  
Tomas Mickevicius ◽  
Alius Pockevicius ◽  
Audrius Kucinskas ◽  
Rimtautas Gudas ◽  
Justinas Maciulaitis ◽  
...  
Keyword(s):  
Articular Cartilage ◽  
Platelet Rich Plasma ◽  
Allogeneic Transplantation ◽  
Staining Intensity ◽  
Quality Parameters ◽  
Electromechanical Properties ◽  
Diagnostic Device ◽  
Safranin O ◽  
Femoral Condyles

Objective To determine the applicability of a minimally invasive diagnostic device to evaluate the quality of articular cartilage following autologous (OAT) and allogeneic (OCA) osteochondral graft transplantation in goat model. Design OAT grafts were harvested from lateral femoral condyles (LFCs) and transplanted into osteochondral defects created in medial femoral condyles (MFCs) of contralateral knees. OCA grafts were transplanted into MFC condyles after in vitro storage. Autologous platelet-rich plasma (PRP) was administered intraarticularly after the surgery and at 1 and 2 months postoperatively. OAT and OCA grafts were evaluated macroscopically (Oswestry arthroscopy score [OAS]), electromechanically (quantitative parameter, QP), and histologically (O’Driscoll score, safranin O staining intensity) at 3 and 6 months after transplantation. Results were compared with preoperative graft evaluation. Results Transplanted cartilage deteriorated within 6 months in all groups. Cartilage quality was better retained in OAT group compared with a decline in OCA group. QP and OAS scores were comparable in OAT and OCA groups at 3 months, but superior in OAT group at 6 months, according to all the methods applied. PRP injections significantly improved QP and OAS score at 6 months compared with 3 months in OAT group. QP moderately correlated with OAS, O’Driscoll score, and safranin O staining intensity. Conclusions Grafts did not retain preoperative quality parameters at 6 months follow-up; however, OAT were superior to OCA grafts. PRP may have a beneficial effect on macroscopic and electromechanical properties of cartilage; however, histological improvement is yet to be proved. Electromechanical diagnostic device enables reliable assessment of transplanted cartilage.

PP31 Medical Device Regulation: What Is New?

2019 ◽  
Vol 35 (S1) ◽  
pp. 42-43
Author(s):  
Ilse-Barbara Oelze ◽  
Kurt Neeser ◽  
Elvira Müller
Keyword(s):  
Medical Device ◽  
Clinical Data ◽  
Implantable Medical Device ◽  
Diagnostic Device ◽  
Post Market ◽  
In Vitro Diagnostic ◽  
Eu Directives ◽  
The Eu ◽  
Medical Device Regulation

IntroductionIn 2017, the European Union (EU) commission released the final versions of the Medical Device Regulation (MDR) and In-vitro Diagnostic Device Regulation. These regulations will replace the EU directives (Medical Device Directive [MDD], In-vitro Diagnostic Device [IVDD], and Active Implantable Medical Device [AIMD]). EU regulations are effective in all EU countries at date of publication. In contrast, the EU directives must be implemented in national law first.MethodsGuidelines and respective legislation, consultation results and methods/medical device (MD) evaluations were reviewed and analyzed. Decision criteria and reasoning, assessment outcomes and potential impact on price negotiations were the main aspects for comparison.ResultsManufacturers have to be aware of the importance of clinical data for demonstrating the compliance of their products. This applies both to the approval of the products and the “post-market activities” and particularly to the “post-market clinical follow-up” for which requirements for Class I and II products need to be further developed. The MDR requires manufacturers to collect clinical data before and after approval, which could lead to excessive documentation requirements. The term “sufficient clinical data” from the MDR is unclear. A functional Eudamed specification is necessary, which enables an automated processing of relevant data. A stronger involvement in the evaluation process is needed as well as more transparency in the Joint Federal Committee (G-BA) and faster evaluation processes.ConclusionsThe MDR increases the burden especially for small businesses, and it is doubtable that the ultimate goal – improving patient safety – will be achieved. The increased demands and rising costs of the new EU MDR and bottlenecks at Notified Bodies can be a risk for the MD industry. Due to the general reduction in the remuneration for services with a high proportion of technical services, it is feared that products will be withdrawn from the market for economic reasons or that they will not be marketed.

scholarly journals Sensitivity and specificity of in vitro diagnostic device used for influenza rapid test in Taiwan

2014 ◽  
Vol 22 (2) ◽  
pp. 279-284
Author(s):  
Kun-Teng Wang ◽  
Chia-Pei Lin ◽  
Yi-Ya Fang ◽  
Ming-Hui Kao ◽  
Daniel Yang-Chih Shih ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Rapid Test ◽  
Diagnostic Device ◽  
In Vitro Diagnostic
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