FDA issued a safety notice to doctors and patients regarding the use of robotically-assisted surgical devices for mastectomy and other cancer-related procedures.
Regulatory and Compliance
FDA has warned several facilities against illegally marketing and distributing unapproved thermography devices as a sole screening device for breast cancer and other diseases.
The company's eye-tracking technology has the potential to solve an important unmet need for providing objective measurements to aid in the assessment of concussion.
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.
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.
What should medical device companies be doing to mitigate cybersecurity risks? One expert shared his insight on the subject during MD&M West 2019.
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.
Awaiting congressional approval, the United States-Mexico-Canada Agreement could reduce duplicative regulations while increasing intellectual property protections, among other changes.
The New Year offers the chance to review your company’s marketing and sales practices given recent enforcement activity
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.