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New on MedTech Intelligence:
Medtronic Recalls MindFrame Capture LP Revascularization Device
http://bit.ly/2IV9RWu
There is a risk that the delivery wire could break or separate during use, being left inside the patient’s bloodstream as a result.

There is a risk that the delivery wire could break or separate during use, being left inside the patient’s bloodstream as a result.
medtechintelligence.com

New on MedTech Intelligence:
Security for Connected Medical Devices
http://bit.ly/2rNijfB
Why does anyone want to hack a medical device or steal medical data? The risk may appear low, but unfortunately this is not the case.

Why does anyone want to hack a medical device or steal medical data? The risk may appear low, but unfortunately this is not the case.
medtechintelligence.com
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New on MedTech Intelligence:
FDA Publishes FDARA Mandated Report on Servicing of Medical Devices
http://bit.ly/2IlDYH6
The report discusses the quality, safety and effectiveness of medical device servicing by OEMs and third parties.

The report discusses the quality, safety and effectiveness of medical device servicing by OEMs and third parties.
medtechintelligence.com

New on MedTech Intelligence:
Product Design Error Triggers Vyaire Medical Class I Recall
http://bit.ly/2rJvdLA
In the United States, the company has recalled nearly 360,000 AirLife Resuscitation Device and Broselow Convenience Kits due to a malfunction risk.

In the United States, the company has recalled nearly 360,000 AirLife Resuscitation Device and Broselow Convenience Kits due to a malfunction risk.
medtechintelligence.com

New on MedTech Intelligence:
Inspection Equipment not Qualified Equates to Problems with FDA!
http://bit.ly/2I89mc9
All equipment must be qualified and calibrated for its intended use.

All equipment must be qualified and calibrated for its intended use.
medtechintelligence.com

New on MedTech Intelligence:
Diseases of the Kidney on Rise Across Asia
http://bit.ly/2I4yEHK
The need is growing for life-saving treatments.

The need is growing for life-saving treatments.
medtechintelligence.com

New on MedTech Intelligence:
Closing the Loopholes in MRI Safety: Using Ferromagnetic Detections Systems to Prevent Projectile Events
http://bit.ly/2HXmUmA
When ferromagnetic objects enter an MRI suite, they become a serious hazard – here’s how to prevent them from getting in.

When ferromagnetic objects enter an MRI suite, they become a serious hazard – here’s how to prevent them from getting in.
medtechintelligence.com

New on MedTech Intelligence:
Rapidly Changing POC Assay Development Opportunity
http://bit.ly/2rce6lv
In the quest for faster, more accurate results, these products will have a tremendous impact on diagnosing infectious diseases.

In the quest for faster, more accurate results, these products will have a tremendous impact on diagnosing infectious diseases.
medtechintelligence.com

New on MedTech Intelligence:
FDA Releases Draft Guidance for Multiple Function Devices
http://bit.ly/2rayUtP
The document aims to clear up how the agency looks at device functions that aren’t subject to premarket review of safety and effectiveness.

The document aims to clear up how the agency looks at device functions that aren’t subject to premarket review of safety and effectiveness.
medtechintelligence.com

New on MedTech Intelligence:
Two New Accounting Standards Disrupting Medical Device Companies
http://bit.ly/2Kie9Fe
Changes in financial reporting can be an annual disruption for medical device companies. But the impact of recent changes to financial accounting standards is likely the most sweeping since the passage of the Sarbanes Oxley Act of 2002.

Changes in financial reporting can be an annual disruption for medical device companies. But the impact of recent changes to financial accounting standards is likely the most sweeping since the passage of the Sarbanes Oxley Act of 2002.
medtechintelligence.com

New on MedTech Intelligence:
In Vitro Diagnostics Registration and Reimbursement in China
http://bit.ly/2KfpbuE
Access to the IVD market in China is lengthy and complicated.

Access to the IVD market in China is lengthy and complicated.
medtechintelligence.com

New on MedTech Intelligence:
Three Areas Where Tissue Engineering Is Changing Medical Treatment
http://bit.ly/2KcLdyl
Tissue scaffolding, nerve grafting and skin printing hold promise, but there is much more work to be done.

Tissue scaffolding, nerve grafting and skin printing hold promise, but there is much more work to be done.
medtechintelligence.com

New on MedTech Intelligence:
Problematic DHRs, Oh My!
http://bit.ly/2Hog4Kn
Can your company prove its device has been manufactured in accordance with its DMR?

Can your company prove its device has been manufactured in accordance with its DMR?
medtechintelligence.com

New on MedTech Intelligence:
Problematic DHRs, Oh My!
http://bit.ly/2Hog4Kn
Can your company prove its device has been manufactured in accordance with its DMR?

Can your company prove its device has been manufactured in accordance with its DMR?
medtechintelligence.com

New on MedTech Intelligence:
Expanded Use of De Novo Pathway Offers Opportunity for Device Manufacturers
http://bit.ly/2qUawfJ
When applicable, the process provides novel products with a speedier route to market.

When applicable, the process provides novel products with a speedier route to market.
medtechintelligence.com

New on MedTech Intelligence:
HSCA Releases Extensive Cybersecurity Considerations
http://bit.ly/2HbIJlW
The Healthcare Supply Chain Association releases a laundry list of areas in which device companies and providers must increase security of devices and networks.

The Healthcare Supply Chain Association releases a laundry list of areas in which device companies and providers must increase security of devices and networks.
medtechintelligence.com

New on MedTech Intelligence:
J&J Restructure: Will Cost Cuts Affect Suppliers?
http://bit.ly/2H76pry
The company just announced that it is restructuring its global supply chain.

The company just announced that it is restructuring its global supply chain.
medtechintelligence.com