The Latest

  • Republican Presidential Nominee Donald Trump Holds Election Night Event In West Palm Beach
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    Win McNamee/Getty Images via Getty Images
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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.

  • An overhead view of an industrial building affected by flooding, trucks and workers are on the ground in the surrounding area.
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    Retrieved from Aerial Lens on October 10, 2024
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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.

    FDA
  • Donald Trump stands against a backdrop of supporters.
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    Chip Somodevilla via Getty Images
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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.

  • A person walks in a forest with a square device taped to their thigh.
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    Courtesy of Tandem Diabetes Care
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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.

  • A person wearing goggles and holding a clipboard looks at a tray in a laboratory.
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    Courtesy of Exact Sciences
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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.

  • A picture of a blue pulsed field ablation catheter against a gray background.
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    Courtesy of Johnson & Johnson
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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.

    FDA
  • A picture of Siemens Healthineers' headquarters building in Erlangen, Germany.
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    Courtesy of Siemens Healthineers
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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.

  • Illustration of a blood clot blocking red blood cells within an artery or a vein.
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    libre de droit via Getty Images
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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.

  • President-elect Donald Trump addresses a crowd from a podium at the Palm Beach Convention Center on Nov. 6, 2024, in West Palm Beach, Florida.
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    Chip Somodevilla via Getty Images
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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.

    FDA
  • Close up of a robotic arm above several lines of test tubes, with people looking in through a glass window.
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    Courtesy of Ambry Genetics
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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.

  • Portrait of Michelle Brennan
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    Permission granted by Politan Capital Management
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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.

  • A person in scrubs and gloves holds an image of a mammogram above a lighted panel
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    Thomas Andreas via Getty Images
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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.

  • A coil-shaped device is shown moving through a tube with branching structures around it.
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    Courtesy of Medtronic
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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.

  • A building in front of a pond with the sign "Medtronic" on a stone wall.
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    Courtesy of Medtronic
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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.

  • A headshot of Mojdeh Paul against with a window and white wall in the background.
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    Courtesy of Integra LifeSciences Holdings Corporation
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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.