Abbott's glucose monitoring system with real-time alarms wins EU nod

Europe – Abbott’s glucose monitoring system with real-time alarms wins EU nod

Abbott's FreeStyle Libre 2 glucose-monitoring system, which comes with optional real-time alarms for high and low glucose levels, has been granted a CE Mark for use...
CDRH Drafts New Framework to Create a Pediatric Device Safety Network

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...
FDA Finalizes Buprenorphine Drug Development Guidance

USA – US FDA Launches Pilot to Expand Special 510(k) Market Pathway

EMERGO SUMMARY OF KEY POINTS: US FDA launching pilot program to expand Special 510(k) route for modifications to medical devices. Pilot would allow more...
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...
Gottlieb Defends Digital Health Approach

USA – Gottlieb Defends Digital Health Approach

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Wednesday defended the agency’s approach to regulating digital health apps following the de novo...
IMDRF Takes Up Cybersecurity, Premarket Reviews, Personalized Device Pathways

USA – IMDRF Takes Up Cybersecurity, Premarket Reviews, Personalized Device Pathways

The International Medical Device Regulators Forum (IMDRF) has begun wading into harmonizing the premarket review process, regulatory pathways for personalized devices and cybersecurity, following...
FDA to beef up cell and gene therapy staff

USA – FDA Reduces Regulatory Burden for Female Condoms

The US Food and Drug Administration (FDA) on Wednesday issued a final order lowering the regulatory burden for device makers looking to market single-use...
Biosimilar use may increase with scrutiny of high drug prices

USA – US Regulators Update Policies for Medical Device Voluntary Consensus Standards

EMERGO SUMMARY OF KEY POINTS: US FDA draft guidance explains agency’s process for recognizing voluntary consensus standards used for medical device declarations of conformity. ...
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...
Intuitive Surgical Could Help Usher in a New Era for Medtech

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...

NOS PROCHAINES FORMATIONS