Tandem Diabetes Care has received a nod from FDA for the t:slim X2 insulin pump and the approval opens up a new device category – Alternate Controller Enabled Infusion Pumps.
Regulatory and Compliance - News
The company has had significant struggles with the EndoBarrier in the past, but a nod from FDA and the IRB to begin a new pivotal trial might be step back in the right direction for the technology.
The suspension follows the Irvine, CA-based company’s voluntary recall of the device earlier this month.
FDA has about two or three months of device user fees as the backlog of unreviewed devices continues to grow.
FDA took the next steps this week toward establishing the framework that is now being called the Safety and Performance Based Pathway. The agency also is seeking input from the industry on its plan to promote the use of more modern predicate devices in the 510(k) program.
The Irvine, CA-based company said it was limiting the device to only be available for use under clinical protocol with pre-screened patients that adhere to the current indications.
Bayer has already decided to stop selling the controversial birth control device, but FDA says it will continue to monitor the long-term safety of Essure.
Check-Cap received CE mark for its C-Scan Capsule in January of this year, now the Isfiya, Israel-based company is setting its sights on the U.S. market.
FDA said interim results from sampling studies indicate higher-than-expected contamination rates after reprocessing of duodenoscopes currently on the market.
Olympus agreed to pay $85 million to settle a federal investigation of its that began in 2015. A former executive also pleaded guilty and faces up to a year in prison.
FDA proposed a new rule that, if finalized, could motivate more companies to choose the de novo pathway for new devices that do not have a modern predicate.
A medical device supplier is recalling certain lots of its temporary bipolar pacing leads that are used in conjunction with a compatible external pulse generator for the temporary pacing and sensing of the heart.
Zimmer Biomet initiated the recall due to the lack of adequate validation and controls to ensure that final products were clean and free from bacteria and chemical residue.