Medical Devices: Page 24

  • A person playing pickleball wears a circular patch on their upper arm.
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    Courtesy of Dexcom
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    Dexcom prices first over-the-counter glucose monitor

    Known as Stelo, the device is intended for people who don’t take insulin and costs $89 per month.

    By • Aug. 26, 2024
  • A sign reading Food and Drug Administration is seen above a door to a government building.
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    Sarah Silbiger via Getty Images
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    Defibtech recalls chest compression device linked to patient death

    Customers are asked to return affected devices due to a problem in the motor that could stop compressions.

    By • Aug. 26, 2024
  • the FDA Headquarters Explore the Trendline➔
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    Sara Silbiger via Getty Images
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    Trendline

    Top 5 stories from MedTech Dive

    From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
  • FDA headquarters with sign in foreground
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    Sarah Silbiger via Getty Images
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    FDA seeks feedback on predetermined change control plans

    The guidance describes changes companies can make to medical devices without filing a new 510(k) or premarket approval supplement.

    By • Aug. 26, 2024
  • The lobby of Stryker's new headquarters building in Portage, Michigan, is pictured.
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    Retrieved from Stryker on August 23, 2024
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    Stryker to add back pain treatment with Vertos Medical buy

    Stryker’s latest purchase comes amid a pickup in medtech M&A, with Johnson & Johnson, Boston Scientific and Edwards Lifesciences all active this year.

    By • Aug. 23, 2024
  • An image of the Procept Biorobotics system against a white background.
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    Courtesy of Procept Biorobotics
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    Procept wins FDA clearance for updated prostate surgery robot

    Procept Biorobotics has added AI capabilities and switched to a single-use scope to support mass-market adoption.

    By • Aug. 22, 2024
  • Judges Or Auctioneer Gavel On The Dollar Cash Background
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    Avosb via Getty Images
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    Zoll to buy Vyaire’s ventilator business with $37M auction bid

    Vyaire Medical held a virtual auction of assets after filing for Chapter 11 bankruptcy protection in June.

    By • Aug. 21, 2024
  • A Marantz home entertainment system is pictured on a wooden table top with a city skyline at nighttime visible in the background through a window.
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    Retrieved from Masimo on August 20, 2024
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    Masimo’s consumer audio brands attract more suitors

    Negotiations with a potential joint venture partner will continue while Masimo initiates discussions with new parties that have expressed interest in the consumer audio business.

    By • Aug. 21, 2024
  • U.S. Government Accountability Office
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    "Government Accountability Office Building" by kafka4prez is licensed under CC BY-SA 2.0
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    FDA’s plan to expand device surveillance faces challenges, GAO finds

    Funding issues and limited use of unique device identifiers are hurdles to expanding an FDA system to monitor medical device safety, the federal watchdog said.

    By • Aug. 21, 2024
  • V-Wave's implantable device for heart failure is shown next to a dime.
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    Permission granted by Johnson & Johnson
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    J&J to buy heart failure implant maker V-Wave for up to $1.7B

    J&J has agreed to pay $600 million upfront for the private company as it works to expand its portfolio of cardiovascular devices.

    By • Aug. 20, 2024
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    Edwards Lifesciences
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    Edwards continues M&A spree with Genesis’ TAVR tech

    Edwards, which has made a series of acquisitions in recent months, is also investing $25 million in Singapore-based Genesis Medtech.

    By • Aug. 19, 2024
  • 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
  • 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