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From Surgeries To Keeping Company: The Place Of Robots In Healthcare

The Medical Futurist

Robotic nurses dressing mannequins and bed-bathing patients Delicate movement, like gently handling an elderly patient is traditionally the most challenging task to robots, who are much faster developing in intellectual tasks than matching humans in fine-motor skills. By 2027, global surgical robotics sales are expected to reach $14.8

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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them.

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No Sleep ‘Til District Court: Jazz Sues FDA Over Sodium Oxybate Clinical Superiority Determination

FDA Law Blog

This time, rather than use codes and patent certifications, the fight is over orphan drug exclusivity (“ODE”), with Jazz challenging FDA’s clinical superiority decision concerning sodium oxybate in the treatment of narcolepsy. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE.

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“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

FDA Law Blog

The striking phrase “valley of death,” is generally understood to refer to the tendency for innovative technologies to fail to reach market, whether due to reimbursement and/or physician or patient preference. up to 225 total products enrolled through FY 2026 and up to 325 total products enrolled through FY 2027).