FDA approved Pulmonx Inc.'s Zephyr Endobronchial Valve through the agency's breakthrough device designation.
Regulatory and Compliance
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.
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.
By 2020, new medical device products distributed within Europe must comply with the new European Medical Device Regulation. Is your company ready?
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.
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.
The Department of Homeland Security has warned in a report that there are cybersecurity vulnerabilities in Medtronic’s N’Vision clinical programmer.
FDA is trying to stop two stem cell clinics from marketing unapproved products and for "significant deviations" from current good manufacturing practice requirements.
Draft guidance from FDA offers a more specific way to demonstrate substantial equivalence for certain devices. But will it really be less burdensome?
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?