The Latest
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Courtesy of Johnson & Johnson
J&J’s Ottava surgical robot to begin clinical trial after FDA nod
With FDA approval of an investigational device exemption, J&J’s soft tissue robot moves a step closer to challenging Intuitive Surgical’s da Vinci system.
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Permission granted by Boston Scientific
Boston Scientific resumes PFA trial in new patient group after pausing enrollment
Boston Scientific expects to complete enrollment in the coming months in the study comparing pulsed field ablation to anti-arrhythmic drugs in patients with persistent AFib, a spokesperson said.
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Courtesy of GE Healthcare
GE Healthcare inks AI mammography pact with Radnet
The alliance positions GE Healthcare to distribute Radnet software designed to help mammography centers view images, prioritize cases and support other steps in the workflow.
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Win McNamee/Getty Images via Getty Images
Advamed CEO congratulates Trump, stresses need for public policy support
Donald Trump’s election victory comes weeks after the FDA named a new leader for the medical device center and as the agency’s contentious LDT final rule is challenged in court.
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Retrieved from Aerial Lens on October 10, 2024
Baxter to restart second IV fluid production line at hurricane-damaged site
CFO Joel Grade told investors Friday that Baxter expects an approximately $200 million hit to sales in the fourth quarter from Hurricane Helene's disruption.
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Chip Somodevilla via Getty Images
How the healthcare industry is reacting to a second Trump term
Donald Trump’s first term as president was characterized by significant turbulence for government healthcare programs. Here’s how some of the most influential industry groups responded to the Republican’s reelection.
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Courtesy of Tandem Diabetes Care
Tandem, Insulet tout Type 2 expectations as tech attracts new users
Insulet saw strong insulin pump adoption among new users with Type 2 diabetes following its recent FDA clearance, while Tandem plans to file a Type 2 submission by year’s end.
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Courtesy of Exact Sciences
Exact Sciences’ forecast cut shocks analysts
The lowered sales forecast, which analysts called a “shocking guidance update,” contributed to a 23% drop in the cancer screening company’s stock on Wednesday.
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Courtesy of Johnson & Johnson
J&J wins FDA approval for Varipulse PFA system
J&J is the third medtech company to gain U.S. approval for pulsed field ablation, a new atrial fibrillation treatment seeing rapid adoption.
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Courtesy of Siemens Healthineers
Siemens Healthineers confident it can cope with Trump tariffs
CEO Bernd Montag said the company is well positioned for a “U.S. versus China situation” that could arise when Donald Trump returns to the White House.
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libre de droit via Getty Images
Inquis raises $40M for pivotal trial of clot removal device
The Aventus thrombectomy system uses technology that tells operators if the device’s tip is in contact with blood, a clot or vessel walls.
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Chip Somodevilla via Getty Images
With Trump victorious, biotech industry’s focus turns to his plans for FDA, FTC
The president-elect has said he’ll let Robert F. Kennedy Jr. “go wild” on healthcare, while many expect a leadership change at the FTC could lower M&A scrutiny.
