The Latest

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  Oracle launches AI-backed EHR

  The records system is available for U.S. ambulatory providers, pending regulatory approval. Oracle plans to launch in the acute care market next year.

  AI

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  Cardiosense appoints John Martin as chief medical officer

  The appointment comes weeks after the company received 510(k) clearance for its wearable heart monitor.

  Medical Devices

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  Draeger removes ventilation filters over misleading carbon dioxide readings

  Hospitals are being advised to stop using the filters after serious injuries were reported related to the problem, the FDA said in a recall notice.

  Medical Devices

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  SetPoint Medical secures $140M to fund neuromodulation for arthritis

  Abbott and Boston Scientific are among the investors in SetPoint, whose neurostimulation device gained FDA approval last month.

  Medical Devices

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  Heartflow’s IPO raises $364M

  The company’s stock rose in its first two days on public markets, closing on Monday up almost 58% over the IPO price amid investor enthusiasm.

  Medical Devices

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  Hospitals prepare for $149B cut to Medicaid state-directed payments

  New limits to the program could force hospitals to slash capital spending while bracing for millions of newly uninsured patients.

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  US to maintain lower tariff rates on China imports for 90 more days

  China also extended its suspension of additional retaliatory duties against U.S. goods, maintaining current rates until November.

  Medical Devices

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  Apreo raises $130M for pivotal trial of emphysema device

  The company, which received investment from the venture capital wing of Intuitive Surgical, has designed the device to work in a broader patient population than existing treatments.

  Medical Devices

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  Boston Scientific updates instructions of devices linked to 17 deaths

  The update covers devices used in procedures to implant the company’s Watchman heart device.

  Medical Devices

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  Tandem, Insulet monitoring CMS payment proposal for diabetes tech

  The proposal would introduce competitive bidding for insulin pumps and change how Medicare pays for diabetes devices, if finalized.

  Medical Devices

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  Tandem insulin pump malfunction linked to 59 injuries

   A problem with speakers in Tandem’s t:slim X2 insulin pumps can cause insulin delivery to stop, the company said.

  Medical Devices

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  Masimo appoints several senior execs, resolves cyber incident

  The pulse oximeter maker is now fully operational after a spring cyberattack and increased its 2025 profit forecast, but investors have raised questions about the status of a partnership with Philips.

  Medical Devices

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  Boston Scientific tells users about defibrillator problem linked to deaths, injuries

  A company spokesperson said in a statement to MedTech Dive that direct causation between the deaths and calcification of the leads cannot be assumed or confirmed.

  Medical Devices

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  FTC moves to block Edwards’ JenaValve acquisition

  Edwards Lifesciences and JenaValve said they remained committed to completing the deal and would defend the case in court.

  Legal

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  Zimmer is latest medtech firm to lower expected tariff hit

  CFO Suketu Upadhyay said the company now expects a charge in 2025 of about $40 million, compared with a range of $60 million to $80 million.

  Earnings

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  Trump plans 100% tariffs for semiconductor imports

  Chips are one of several product types currently under Section 232 investigation by the White House, a frequent precursor to duties.

  Medical Devices

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  BD commits $35M to expand US syringe production plant

  The company said it has grown capacity by 10% this year, bringing its total U.S. output of the prefilled flush syringes to above 750 million units.

  Medical Devices

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  Medical device industry says future MDUFA hikes unsustainable

  Device lobbyists’ priorities contrasted with patient advocates, who sought an increase in user fees and more funds for postmarket safety.

  Medical Devices

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  Alcon to acquire STAAR Surgical for about $1.5B

  BTIG analyst Ryan Zimmerman called the transaction “a solid deal” for Alcon given STAAR’s struggles in the China market.

  Medical Devices

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  Philips BiPAP machine recall associated with 8 deaths

  Philips sent updated instructions after disclosing problems last year with an alarm that can interrupt treatment for people with obstructive sleep apnea or respiratory insufficiency.

  Medical Devices