CDRH Proposed Guidances for Fiscal Year 2020

USA – CDRH Drafts New Framework to Create a Pediatric Device Safety Network

A draft framework is in the works at the US Food and Drug Administration (FDA) to create an innovative safety net for pediatric medical...
FDA informs patients, providers and manufacturers about potential cybersecurity vulnerabilities for connected medical devices and health care networks that use certain communication software

USA – FDA Warns of Cyber Vulnerability in Medtronic Implantable Cardiac Devices

The US Food and Drug Administration (FDA) on Thursday issued a safety communication to alert of cybersecurity vulnerabilities for Medtronic cardiac implantable electrophysiology devices...
Body Vision Releases LungVision for Early-Stage Lung Cancer Diagnostics

International – Body Vision Releases LungVision for Early-Stage Lung Cancer Diagnostics

Body Vision Medical out of Ramat Ha Sharon, Israel is releasing its LungVision platform for planning, navigating to, and targeting small pulmonary nodules within the...
CDRH Proposed Guidances for Fiscal Year 2020

USA – CDRH Works to Develop Proposed De Novo Regulation

The regulatory review pathway for novel devices will receive major policy clarifications by mid-2019, program lead at the US Food and Drug Administration’s (FDA)...
Eximo Medical’s Atherectomy Laser Cleared by FDA

USA – Eximo Medical’s Atherectomy Laser Cleared by FDA

The FDA granted 510(k) clearance for Eximo Medical’s B-Laser atherectomy system, used for treating patients with peripheral artery disease, including in-stent restenosis. The device —...
Medical devices: the shift from embedded to connected

International – 5 Innovative Trends of the Future in Healthcare and Medical Device Manufacturing

With such fast-paced innovation in medical devices, the requirements of materials are changing. Implantable devices will be capable of monitoring, controlling and administering treatments,...
10 Medical Devices Recently Approved by FDA

USA – Self-Fitting Hearing Aid Receives Nod from FDA

A newly-approved device could change the way patients manage their hearing loss. Last week, FDA greenlit the Bose Hearing Aid, which is called the...
Roche CoaguChek device producing inaccurate results

UK – Roche CoaguChek device producing inaccurate results

People on blood thinners who use the CoaguChek device to test their blood clotting function are being urged to check their test strips, following...
European Pharmacopoeia revises general chapter on degree of coloration of liquids

Europe – The EDQM has issued a set of recommendations for the development of...

The EDQM has issued a set of recommendations for the development of cost-effective and sustainable Quality Management Systems (QMSs) in Blood Establishments (BEs) across...
CDRH Proposed Guidances for Fiscal Year 2020

USA – CDRH Offers Look at Upcoming Guidance Documents in FY 2019

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Wednesday published three lists of guidance documents that may...

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