The Latest
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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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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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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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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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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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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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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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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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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.
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Tempus AI to buy genetic testing company for $600M
CEO Eric Lefkofsky said the purchase of Ambry Genetics will expand Tempus’ testing portfolio and bring in a fast-growing business.
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Masimo, amid leadership transition, targets cost reductions
Executives said the patient monitoring company’s consumer business will likely become a discontinued operation if it is not spun off.
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Advamed asks CMS to cover extra imaging of dense breast tissue
Many patients with dense breast tissue currently have to pay out of pocket or forgo potentially life-saving additional testing, Advamed said in a letter.
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Medtronic, Recor win CMS transitional payment coverage for renal denervation devices
Patient and physician education is the next challenge to change the treatment paradigm for drug-resistant hypertension, Citi Research analyst Joanne Wuensch said.
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Baxter, Medtronic, Insulet to wrap up medtech earnings
Baxter will share an update on Hurricane Helene’s impact, while Medtronic will likely discuss a new pulsed field ablation device.
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Integra Lifesciences names Mojdeh Poul as CEO
Poul will take over the company in January after spending 11 years with 3M and working at Medtronic and Boston Scientific.