FDA’s Draft Guidance Lays Out Recommendations for Medical Devices with Cybersecurity Risks
The draft provides suggestions on device design, labeling and documentation that should be included in premarket submissions.
FDA Approves Abbott’s Heartmate 3 Heart Pump
The device is indicated for patients who have advanced heart failure and are not eligible for a transplant.
Endologix Recalls More Than 61,000 AAA Systems Due to Endoleak Risk
There have been reports of Type llla and lllb endoleaks related to the company’s AFX Endovascular AAA Systems.
Take the EU MDR Compliance Cost Questionnaire
Does your company understand the magnitude of the compliance effort?
For Second Year in a Row, Cybersecurity Issue Tops ECRI Health Tech Hazards List
Hackers and their ability to access systems remotely and disrupt healthcare organizations are a key concern.
Apple Watch 4 Gets FDA Clearance
The product can conduct electrocardiograms and measure the heart’s rhythms.
FDA Awards $6 Million in Grants for Pediatric Device Development
Innovators will also receive guidance in the areas of prototyping, engineering, IP, testing, grant-writing and clinical trial design.
FDA Issues Draft Guidance on Considerations of Uncertainty in Making Benefit-Risk Determinations for Premarket Decisions
The agency is aiming to provide more transparency and consistency in this area.
“We Are Now Out of Time”: Theranos to Dissolve
The Wall Street Journal reports that the scandal-ridden company will dissolve after failing to sell itself, and investors will lose nearly $1 billion.
Top MedTech Summer Stories
Following protocols and maintaining compliance have been common themes.
