Medical Devices: Page 21

  • Histosonics' Edison histotripsy system is pictured in an operating room.
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    Permission granted by Histosonics
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    Histosonics raises $102M for noninvasive treatment to destroy tumors

    Using sound waves to break down tumor tissue can offer patients with liver cancer an alternative to surgery, radiation and chemotherapy.

    By • Aug. 19, 2024
  • Two people wearing suits stand in between two people talking wearing white coats in a laboratory setting.
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    Erin Scott / U.S. White House. Retrieved from Flickr.
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    Biden pledges $150M for medical tech to improve cancer surgery

    Awards include funding for microscopy and imaging tools to help surgeons ensure all cancer is removed during a procedure.

    By • Aug. 16, 2024
  • Front sign of FDA building Explore the Trendline➔
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    Sarah Silbiger via Getty Images
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    Trendline

    Medical device safety in spotlight after high profile recalls

    From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

    By MedTech Dive staff
  • A picture of Stereotaxis' GenesisX surgical robot against a white background.
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    Permission granted by Stereotaxis
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    Stereotaxis earns CE mark for new surgical robot

    CEO David Fischel said the platform, called GenesisX, is designed to address challenges hospitals have faced when installing the company’s earlier robotic systems.

    By • Aug. 15, 2024
  • A person smiles while wearing a square device on their hip and a round device on their upper arm.
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    Courtesy of Tandem Diabetes Care
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    Tandem warns iPhone app still draining insulin pump batteries

    Despite a software update in March, users are still reporting that the app is rapidly depleting their insulin pump batteries, causing unexpected shutdowns.

    By • Aug. 15, 2024
  • A picture of the Neurostar chair
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    Permission granted by Neuronetics
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    Neuronetics inks Greenbrook merger to acquire treatment centers

    William Blair analysts said the deal changes Neuronetics’ profile “from device-centric to a device-service business operating brick-and-mortar facilities.” 

    By • Aug. 15, 2024
  • A person holds a phone that shows an image of a face with the prompt: "Does this emotion match the previous one?"
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    Retrieved from Otsuka Precision Health on August 14, 2024
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    Otsuka Precision Health launches first digital therapeutic for depression

    Intended to supplement medications, the six-week, app-based treatment will cost $50 on a cash-pay basis.

    By • Aug. 14, 2024
  • A person fits a tool in a robot arm while two other people wearing masks, caps and gloves stand around a hospital bed.
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    Retrieved from Globus Medical on August 14, 2024
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    Globus receives warning letter over spine navigation robot

    The FDA said Globus delayed reporting complaints about misplaced screws, despite information that “reasonably suggests” the Excelsius GPS system malfunctioned.

    By • Aug. 14, 2024
  • A windowed building surrounded by trees with a sign "Baxter" in front
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    Tim Boyle via Getty Images
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    Baxter agrees to sell kidney care unit to Carlyle for $3.8B

    Selling the business, called Vantive, rather than spinning it off, should maximize shareholder value and give Baxter more flexibility to pursue other growth opportunities, the company said.

    By • Aug. 13, 2024
  • 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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    Medtronic wins FDA approval for asleep deep brain stimulation

    Medtronic said Monday it is the first company to receive FDA approval to offer DBS surgery while a patient is asleep or awake.

    By • Aug. 13, 2024
  • A picture of Breas Medical's Vivo 45 LS ventilator device against a white background.
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    Retrieved from Breas Medical on August 12, 2024
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    Breas Medical flags risk of formaldehyde exposure in ventilators

    Testing showed the potential for short-term exposure to elevated levels of formaldehyde under specific conditions.

    By • Aug. 12, 2024
  • Professional photo of Bryan Hanson
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    Courtesy of 3M
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    Solventum raises earnings forecast after first independent quarter

    Four months after separating from 3M, CEO Bryan Hanson told investors on Solventum’s first earnings call that “a lot could have gone wrong, and it didn’t.”

    By • Aug. 9, 2024
  • FDA headquarters with sign in foreground
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    Sarah Silbiger via Getty Images
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    Smiths Medical recalls infusion pumps over software issues

    The devices may fail to emit alarms, have unresponsive stop and power keys, and reveal passwords.

    By • Aug. 9, 2024
  • A headshot of new Axogen CEO Michael Dale.
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    Permission granted by Axogen
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    Axogen names ex-Abbott exec Michael Dale as CEO

    Dale will replace Karen Zaderej, who is leaving the provider of peripheral nerve injury devices after 14 years as CEO.

    By • Aug. 9, 2024
  • An x-ray image shows a hip bone with an overlay showing an angle.
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    Courtesy of Orthogrid Systems
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    Zimmer to buy surgical navigation company Orthogrid

    CEO Ivan Tornos said Zimmer hopes to grow its market share in hip procedures with the purchase. He also shared an update on the company’s new shoulder surgical robot.

    By • Aug. 8, 2024
  • Chiquita Brooks-LaSure sits behind a desk testifying before a congressional subcommittee.
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    Rebecca Pifer/MedTech Dive
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    CMS finalizes notice on Medicare coverage for breakthrough devices

    Through the new pathway, called Transitional Coverage for Emerging Technologies, the CMS will consider five medical device candidates yearly for national coverage.

    By • Aug. 8, 2024
  • A metal, rounded device says "Senza Omnia" and has two attached leads.
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    Courtesy of Nevro
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    Nevro considers sale as competition for pain market ramps up

    CEO Kevin Thornal told investors Nevro felt “an urgency” to respond to a market that is being reshaped by direct and indirect competition.

    By • Aug. 8, 2024
  • A person stands outside wearing a small, square device with a cord on their belt.
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    Permission granted by Medtronic
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    Abbott, Medtronic partner on diabetes tech

    Abbott will develop a glucose sensor that can only connect with Medtronic's insulin delivery technology.

    By • Aug. 7, 2024
  • A brick building with a sign that says "Henry Schein Inc."
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    Bruce Bennett via Getty Images
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    Henry Schein’s slow recovery from cyber incident hits Q2 results

    William Blair analysts said the “lingering impacts from the cyberattack are somewhat surprising.”

    By • Aug. 7, 2024
  • 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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    Medtronic recalls nerve monitoring system linked to 10 injuries

    Medtronic has asked users to be aware the devices may not alert when on a nerve, which could lead to injuries during surgery.

    By • Aug. 7, 2024
  • Food And Drug Administration Headquarters In Maryland
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    Sarah Silbiger via Getty Images
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    FDA seeks feedback on health equity for medical devices

    The agency plans to develop a framework for when devices should be evaluated in diverse populations to support marketing authorization.

    By • Aug. 6, 2024
  • A person playing a guitar in front of a microphone holds up a phone with a blood glucose reading on it.
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    Courtesy of Ascensia Diabetes Care
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    Q&A

    Ascensia’s new head of CGM talks plans for a 365-day sensor

    Brian Hansen recently joined Ascensia, which markets Senseonics’ implantable glucose sensors. The current version lasts 180 days, but Senseonics is seeking FDA approval for a one-year sensor.

    By • Aug. 6, 2024
  • A picture of Inspire Medical Systems' patient app and remote.
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    Courtesy of Inspire Medical Systems
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    Inspire wins FDA approval for obstructive sleep apnea neurostimulator therapy

    Inspire plans to start a soft launch of the device late in 2024 and move into a full release in 2025.

    By • Aug. 5, 2024
  • A picture of J&J's Velys robotic surgery sytem.
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    Courtesy of Johnson & Johnson
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    J&J launches Velys Spine surgical robotics and navigation platform

    With its Velys surgical robotics portfolio, J&J aims to take market share from competitors Stryker and Zimmer Biomet.

    By • Aug. 5, 2024
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    Courtesy of 23andMe
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    23andMe board rejects CEO Wojcicki’s take-private proposal

    A special committee of the board said the proposal offers no premium to 23andMe’s stock price, and with a lack of committed financing, is “insufficient.”

    By • Aug. 2, 2024
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    Courtesy of Philips
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    Philips sues independent lab, alleges ‘numerous egregious errors’ in CPAP foam tests

    Philips claimed PSN Labs overestimated the potential threat to patients, saying it “would have pursued a different and more focused recall” if not for the results.

    By • Aug. 2, 2024