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International -
Management de la qualité : l’ISO 9004 relookée

« Petite sœur » de l’ISO 9001, la norme volontaire ISO 9004 vient d’être révisée. Elle donne des lignes directrices pour déployer un management de la qualité en vue d’obtenir des performances durables dans l’organisation. Comme l’ISO 9001 en 2015, la norme volontaire internationale ISO 9004, l’une de ses petites sœurs, vient d’être relookée. Orchestrée par le comité technique TC 176 de l’ISO (Organisation internationale de normalisation), dans lequel AFNOR représentait la France, la révision a débouché sur un texte publié en avril 2018, disponible dans la collection AFNOR ici neuf ans après...

International -
Real World Data Could Give Edwards Edge in TAVR

TAVR pioneer Edwards Lifesciences has released positive 30-day data of its Sapien 3 valve at EuroPCR. Edwards Lifesciences is continuing to strengthen its position in the transcatheter aortic valve replacement(TAVR) market by revealing real world data for the Sapien 3 valve. The Irvine, CA-based company presented positive 30-data of the device at EuroPCR . The propensity-matched analysis compared real-world data collected from the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry with outcomes of patients enrolled in the...

FDA Clears FlowTriever, First Device to Pull Blood Clots from Lungs

Inari Medical of Irvine, California won the first FDA clearance for a thrombectomy device to be used for treatment of pulmonary embolisms. The FlowTriever went through a clinical study involving 106 patients with acute pulmonary embolism and RV/LV (right ventricular/left ventricular) ratio of at least 0.9 that were treated using the device instead of commonly used clot busters. According to the company, “the mean RV/LV ratio in the study decreased from a baseline of 1.53 to 1.15 at 48 hours postprocedure, a difference of 0.39 (p<0.0001). The study also demonstrated excellent safety at 30...

Asia -
Singapore Eases Registration Requirements for Some Devices

Singapore's Health Sciences Authority (HSA) on Tuesday announced changes to its regulations that it says will facilitate faster access to certain medical devices and mobile applications and provide more clarity to device makers. Specifically, the agency says it plans to exempt some devices from registration requirements based on risks and other factors, such as whether the device is approved by other international regulators and how long it has been on the market. "HSA constantly reviews our regulatory framework to ensure that it stays relevant and forward looking. Having obtained a better...

International -
How Artificial Intelligence Is Changing Medical Devices

An industry expert talks about the dramatic impact that artificial intelligence (AI) is having on the medical device field. Machine learning and artificial intelligence (AI) have long been heralded as the future of transformative technologies. From diagnostic and imaging technologies to therapeutic applications and robotics, the potential for machine learning and AI technologies reaches almost every corner of the medtech world. So, what does that mean for the development and application of next-gen medical devices? Dave Saunders is the chief technology officer of Galen Robotics , an emerging...

Europe -
Tight Deadlines for EU MDR, IVDR Generate Questions for EC, Competent Authorities

Medical device and in vitro diagnostic (IVD) manufacturers on Thursday peppered representatives from the European Commission (EC) and Ireland’s Health Products Regulatory Authority (HPRA) with questions about the upcoming deadlines, implementing acts and guidance related to the new EU device and IVD regulations. Erik Hansson, deputy head of the EC’s Health Technology and Cosmetics Unit, offered a high-level overview of the new regulations to attendees of RAPS’ workshop in Brussels and why they needed to be created, highlighting the building of a new EUDAMED database to strengthen surveillance...

FDA Exempts Surgical Apparel From 510(k) Requirements

Single-use, disposable respiratory protective devices intended for medical professionals’ use in healthcare settings will no longer be subject to premarket notification requirements, following an order the US Food and Drug Administration (FDA) finalized Wednesday. The final exemption order—proposed last December—is intended to reduce regulatory burden on manufacturers of the class II (special controls) devices and eliminate the associated costs. The exempted devices, otherwise known as N95 filtering facepiece respirators and surgical N95 respirators, fall under the umbrella of surgical...

Europe -
EU MDR, IVDR Transition: One Year in, Lots of Guidance Still to Come

One year into the transition periods for the new EU medical device and in vitro diagnostic (IVD) regulations, and not a whole lot has occurred to help companies implement the new regulations, experts said Wednesday in Brussels at RAPS' workshop . The three-year countdown to the new EU Medical Devices Regulation’s (MDR) full application in 2020 (and five years for IVDs) has created an anxious environment for companies, particularly as for most legacy devices (CE marked under the previous device directive), a review of Annex I, General Safety and Performance Requirements, will identify new...

CDRH Turns Down Industry Call for Regulatory Controls Over Third-Party Servicers

As industry associations call on Food and Drug Administration (FDA) to increase regulatory oversight on the servicing of medical devices, a lack of evidence to “justify imposing additional/different burdensome regulatory requirements at this time” caused agency staff to take a different approach, a new report concludes. Manufacturers that contract third-party servicers have raised several issues and concerns over the past few years regarding inadequate handling of devices, urging for regulatory controls in the servicing space. In a new first-of-its-kind report mandated under section 710 of...

International -
WHO Launches First List of Essential Diagnostics

The World Health Organization (WHO) on Tuesday published its first essential diagnostics list (EDL), cataloguing the 113 most critical categories of diagnostics for common and priority diseases. “An accurate diagnosis is the first step to getting effective treatment,” said WHO Director-General Dr. Tedros Adhanom Ghebreyesus. WHO first announced it would develop the list in June 2017 after an expert committee recommended that the agency craft a list of essential in vitro diagnostics (IVDs) for priority diseases including tuberculosis, malaria, HIV and hepatitis B and C. Of the 113 types of...



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