After the Product-Centric Medical Industry – What’s Next?

USA – After the Product-Centric Medical Industry – What’s Next?

For decades, the medical device industry has reaped rewards by providing new technologies and solutions that improve healthcare delivery. Now, more than 8000 new...
Applied Tissue Technologies’ negative-pressure dressing gets FDA nod

USA – Applied Tissue Technologies’ negative-pressure dressing gets FDA nod

Wound-care company Applied Tissue Technologies said it has won FDA clearance of its negative-pressure wound therapy product, the Platform Wound Dressing (PWD). The class...
Contact Lenses: CDRH Drafts Guidance on Performance Criteria to Support 510(k)s

USA – CDRH Revamps 510(k) Clearances With ‘Safety and Performance Based Pathway’

A US Food and Drug Administration (FDA) final guidance sets the stage for how the agency intends to make the voluntary option for 510(k)...
FDA finalizes guidance on clinical, in vitro drug interaction studies

USA – Device makers seek transparency on Breakthrough Devices Program

A consensus of industry participants at a US Food and Drug Administration (FDA) webinar on Thursday pressed for metrics on the medical device priority...
Wearable device studied for detection of pediatric anxiety, depression

USA – Wearable device studied for detection of pediatric anxiety, depression

When Ellen McGinnis started her career as a psychologist several years ago, she realized just how hard it can be to spot anxiety and...
US FDA’s Pre-Cert Pilot for Medical Device Software Moving into Testing Phase

USA – US FDA’s Pre-Cert Pilot for Medical Device Software Moving into Testing Phase

US FDA has issued a new regulatory framework, working model and test plan for its Pre-Cert pilot program for Software as a Medical...
FDA Fleshes Out Guidance on Susceptibility Breakpoints for Antimicrobial Drugs, Devices

USA – FDA Fleshes Out Guidance on Susceptibility Breakpoints for Antimicrobial Drugs, Devices

The US Food and Drug Administration (FDA) issued final guidance Thursday on the coordinated development of antimicrobial drugs and susceptibility assays, with additional clarifications. The...
Regulatory Recap: Global Trends June 2019

USA – Impact of the USMCA on the Medical Device Industry

Since the inception of the North American Free Trade Agreement (NAFTA), trade in medical products expanded nearly 760 percent with 16.5 billion dollars made...
Canada Completes Transition to MDSAP

Canada – Canada Completes Transition to MDSAP

Most companies in the Canada market were able to meet the 1 January deadline to complete the transition into the Medical Device Single Audit...
AdvaMed Calls for Revisions to Health Canada Guidance on 3D-Printed Implantable Devices

Canada – AdvaMed Calls for Revisions to Health Canada Guidance on 3D-Printed Implantable Devices

AdvaMed is asking Health Canada to revise its draft guidance on preparing license applications for implantable medical devices that are produced using additive manufacturing...

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