How a New Emphysema Device Won FDA Approval in Six Months
FDA approved Pulmonx Inc.'s Zephyr Endobronchial Valve through the agency's breakthrough device designation.
Regulatory and Compliance
Misinterpretation of Jaundice Meters Triggers a Recall
Draeger Medical Systems is recalling its Jaundice Meter JM-103 and JM-105 models after some users have misinterpreted display messages that have resulted in serious injuries.
What You Need to Know about FDA’s Draft Guidance on Writing Test Reports
New draft guidance recommends formats for test and summary reporting.
FDA Panel Shoots Down Endobronchial Coil System – Is the Device Doomed?
An FDA advisory committee concluded that BTG's device for treating severe emphysema patients is safe, but the panel raised concerns about the product's efficacy and whether or not the benefits outweigh the risks.
Ready or Not, Changes Are Coming to Legacy Device Requirements in the EU
By 2020, new medical device products distributed within Europe must comply with the new European Medical Device Regulation. Is your company ready?
More Patients Are Dead After Weight-Loss Balloon Surgery
FDA said a total of 12 patients have died in the past two years after receiving either the Orbera or the ReShape balloon-based systems to treat obesity.
Medtronic Recalls HeartWare VADs Again Due to an Electrical Problem
The Class I recall includes 204,017 HeartWare devices, but the likelihood of the problem causing a serious adverse event in a patient is very low.
Breaking Through FDA’s New “Accelerated” Pathway
Industry specialist speaks about maneuvering through FDA's accelerated pathway.
FDA’s Still Fledgling MDDT Program
Pre-qualified device evaluation tools have not yet been popular.
Medtronic Faces Cybersecurity Risk for Clinical Programmer
The Department of Homeland Security has warned in a report that there are cybersecurity vulnerabilities in Medtronic’s N’Vision clinical programmer.
FDA Lays the Smackdown on Illegal Stem Cell Clinics
FDA is trying to stop two stem cell clinics from marketing unapproved products and for "significant deviations" from current good manufacturing practice requirements.
Squatty Potty Appears to Have Eliminated Its Regulatory Problems
The Utah company has sold hundreds of thousands of devices to help pent-up people poop.
Substantial Equivalency: By Comparison or By Performance?
Draft guidance from FDA offers a more specific way to demonstrate substantial equivalence for certain devices. But will it really be less burdensome?
Is FDA Really Streamlining Its PMA and 510(k) Processes?
As regulatory burdens in Europe have grown, FDA has taken steps toward streamlining. But do efforts aimed at expedited review represent progress or empty promises?
FDA’s Role in the New Era of Medtech Collaboration
As the medical device industry begins to embrace a new era of healthcare collaborations and risk-sharing contracts, what role might FDA play in that trend? This was the question MD+DI posed to a senior advisor to the commissioner of FDA, and his answer might surprise you.