Outset pauses shipments of dialysis accessory after FDA warning letter, denting sales outlook

The halt prompted the company to predict it will now hit the bottom end of its full-year revenue range, a revision that surprised some analysts.

Medtechdive

Q&A: How Monogram’s CEO plans to disrupt robotic joint replacement surgery

The robot developer’s CEO, Benjamin Sexson, tells MedTech Dive why he believes the orthopedics market needs a fresh approach to joint reconstruction.

Medtechdive

A novel approach to IV access

Improvements in IV catheters can lead to better, more compassionate care, says Joseph Smith, BD’s chief scientific officer.

Medtechdive

Bariatric surgery slowdown nips Intuitive Surgical’s Q2 procedure growth

New weight-loss drugs are eroding demand for surgical procedures that employ the company’s robotic systems.

Medtechdive


BD gains FDA clearance to relaunch Alaris infusion pump after recalls

The company will fix or replace older devices still in use at hospitals as it ramps up to resume sales in its market-leading infusion business.

Medtechdive

FDA improves 510(k) turnaround times, but PMA waits hit record high: analysis

The time it took for the FDA to reach 510(k) decisions decreased by 24 days, but the agency is still working through a pandemic-driven backlog of premarket approval applications.

Medtechdive



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