Assessing Hemocompatibility for Medical Devices in Contact with Circulating Blood
Many commonly used medical devices, such as catheters, cardiopulmonary bypass systems, and endovascular grafts, are intended to come in contact with circulating blood. Therefore, these devices require an assessment for hemocompatibility risks such as hemolysis and thrombosis prior to submitting to a regulatory agency for market approval. The testing required for the evaluation of these specific endpoints depends on the exposure type and duration of the specific medical device under focus, and the guidance is captured in Table 1 of ISO 10993-4 Biological evaluation of medical devices - Part 4: Selection of tests for interac...
Source: MDDI - February 20, 2020 Category: Medical Devices Authors: Helin R äägel Tags: Testing Source Type: news
Supplier Stories for the Week of February 16
(Source: MDDI)
Source: MDDI - February 20, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Components Source Type: news
Growing Regulatory Complexity: An Innovation Challenge?
 The considerable rise in regulatory complexity within the global medical device manufacturing community is a challenge that keeps many leaders rethinking the right approach. While the European Union’s Medical Device Regulation (EU MDR) is at the forefront today, the issue certainly isn’t limited to the EU.
Life sciences organizations have a choice with regulatory initiatives: spend the minimal amount to be compliant and live with a patchwork of “silo solutions†or look at challenges such as EU MDR as an opportunity to innovate and moderniz...
Source: MDDI - February 20, 2020 Category: Medical Devices Authors: John Cassimatis, Lisa Cooney, Steve Gens, and Pat Shafer Tags: Regulatory and Compliance Source Type: news
Abbott ’s Coronary Dilation Catheters Face Class I Recall
Abbott Laboratories is facing a Class I Recall of its coronary dilation catheters. The Abbott Park, IL-based company said that “certain lots†of the NC Trek RX Coronary Dilatation Catheter would be impacted by the recall.
According to FDA’s website the firm field personnel and Affiliates directly contacted the first customers beyond the firm's control via phone, email, or personal visit to facilitate rapid notification, Jan. 29, 2020. The "URGENT MEDICAL DEVICE RECALL" Notification informed customers that specific lots of its Coronary Dilatation Catheters with diameters...
Source: MDDI - February 20, 2020 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news
Abbott Picks Up Key Approval for ICD Technology
Abbott Laboratories has won CE mark for the new Gallant implantable cardioverter-defibrillator (ICD) and CRT-D devices. The Abbott Park, Il-based company received approval in Europe on the heels of ICD Week, a celebration of 40 years of the technology.
The new Gallant system pairs with Abbott's secure myMerlinPulse mobile app to help streamline communication and increase engagement between doctors and their patients. For example, the app allows patients to engage more frequently with their healthcare team by providing access to transmission history and device performance, and the app can prompt patients to schedule their n...
Source: MDDI - February 19, 2020 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Implants Source Type: news
