Brian Bossetta

20 hours ago | insights.citeline.com | Brian Bossetta

Serious Injuries Tied To Medtronic Bravo GERD Diagnosing SystemThe US FDA has issued an early alert to notify consumers about serious risks associated with a recall from Medtronic and its subsidiary Given Imaging. The alert concerns delivery capsules for diagnosing GERD.

1 day ago | insights.citeline.com | Brian Bossetta

FDA Blocks Some Olympus Endoscopes From Entering USAfter multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.

2 days ago | insights.citeline.com | Brian Bossetta

Will Kennedy And Makary Come To Terms On User Fees During Next Round Of MDUFA Negotiations? It’s no secret that Marty Makary and Robert F. Kennedy Jr. have a different take on user fees, with Makary viewing them as a funding necessity and Kennedy as a corrupting influence. But will they find a way to strike a balance during the next MDUFA reauthorization talks so each can claim victory?

1 week ago | insights.citeline.com | Brian Bossetta

Medtronic Announces Collaboration To Create A ‘New Era’ in Surgical TrainingMedtronic is teaming up with IRCAD North America to build high-tech training and education experiences for surgeons and medical professionals in cardiovascular, neuroscience, and minimally invasive surgical specialties. The move could also further position Medtronic to seize on the growing robotics

2 weeks ago | insights.citeline.com | Brian Bossetta

With LDT Rule DOA, Could FDA Shift Focus To RUOs? Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?