US FDA cleared Zimmer Biomet's ROSA ONE spine application last Friday. During the recent Academy of Orthopedics Surgeons conference, Medtech Insight talked to Zimmer Biomet's general manager of Global Spine, Rebecca Whitney and Michelle Bianco, VP of Operations, to learn about the company's product pipeline and future strategy.
The highly anticipated US FDA clearance of Zimmer Biomet Holdings Inc.'s ROSA ONE spine application last Friday is welcome news for the company one week after its showcase at this year's American Academy of Orthopedic Surgeons' (AAOS) conference in Las Vegas.
At AAOS, Zimmer Biomet's booth drew surgeons' attention with the ROSA total knee arthroplasty (TKA) robotic system. Surgical robotics are expected to be a rapidly growing business for Zimmer Biomet...
SAGA Diagnostics has launched its breast cancer residual and recurrence detection test – Pathlight – in the US. The test’s ultrahigh sensitivity and specificity is rare to see in oncology, the company claimed.
The imaging, Varian, and advanced therapies segments – which are more reliant on equipment sales – are more heavily affected, with tariffs applying to roughly 55% of their revenue base. In diagnostics, the company expects minimal exposure due to sufficient US value-added manufacturing.
The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.
