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...
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 —...
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...
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...
Boston Scientific’s Eluvia Peripheral Long Term Drug Eluting Stent FDA Approved

USA – Boston Scientific’s Eluvia Peripheral Long Term Drug Eluting Stent FDA Approved

Boston Scientific won FDA regulatory approval to introduce the Eluvia drug-eluting vascular stent to the U.S. market. The device is the first peripheral stent to...
FDA Reveals Vision for the Transition to ISO 13485

USA – FDA Reveals Vision for the Transition to ISO 13485

An apology was offered to device firms during a session at the MedTech Conference in Philadelphia on Tuesday by the US Food and Drug...
Patent Considerations for Connected Medical Devices

USA – Intuitive Surgical Could Help Usher in a New Era for Medtech

More than a decade ago Amazon recognized that it needed mass-cloud computing power, but didn't believe there was a third party service available to...
Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act

USA – Monetary Penalties for Failing to Report Trials: FDA Drafts Guidance

Failing to submit trial data to ClinicalTrials.gov may start to cost drug and device makers, the US Food and Drug Administration (FDA) said Thursday...

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