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  • the FDA Headquarters
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    Sara Silbiger via Getty Images
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    Top CDRH official to retire

    William Maisel, director of the Office of Product Evaluation and Quality, will retire this spring, an FDA spokesperson confirmed.

  • 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 names Raman Venkatesh as first chief sustainability officer

    Venkatesh will be responsible for leading the development and execution of Medtronic’s environmental sustainability strategy.

  • A droplet from a pipette hangs over a series of test tubes in this stock image.
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    K-Kwanchai via Getty Images
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    Freenome raises $254M to study cancer screening tests

    Roche and Quest Diagnostics were among those to invest in the company’s development of early cancer detection blood tests.

  • Portrait of Bill Hunter
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    Permission granted by Canary Medical
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    Q&A

    Canary CEO Bill Hunter talks smart knee implant progress, new heart device

    The company collaborated with Zimmer Biomet on its Persona IQ device, which is slated for a full market release this year. Canary is also working on an implantable monitor for heart failure patients.

  • the FDA Headquarters
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    Sara Silbiger via Getty Images
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    Smiths Medical recalls syringe pumps for software malfunction

    The FDA categorized the recall as Class I, noting that the software faults may cause pumps to fail, delaying or interrupting therapy.

  • Masmio's Mightysat medical fingertip pulse oximeter.
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    Courtesy of Masimo
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    Masimo wins first FDA clearance for OTC medical fingertip pulse oximeter

    The company's OTC device, which costs nearly $300, will compete with consumer pulse oximeters that are widely available but lack FDA clearance.

  • Abbott Laboratories
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    Courtesy of Abbott
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    FDA advisory panel overwhelmingly backs Abbott’s Triclip

    The expert panel voted unanimously in favor of the safety of the tricuspid valve device, despite questions about a potential placebo effect in the trial.

  • Header image for "Chapter 11 Bankruptcy Filings Climbed 79% in March"
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    Getty Images via Getty Images
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    Invitae files for Chapter 11 bankruptcy

    The genetic testing company hopes to keep its employees on payroll as it works through a court-overseen sale.

  • Close up of a watch on a person's wrist that says "sleep apnea 10:17 am"
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    Courtesy of Samsung Electronics
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    Samsung wins de novo nod for watch that detects sleep apnea

    The FDA created special controls that provide a path to market for other developers of over-the-counter devices.

  • A cylindrical device on the left with a wifi signal, next to a black rounded device and a smartphone showing a blood glucose reading.
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    Permission granted by Senseonics
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    Senseonics gains expanded Medicare coverage for implantable CGM

    Three Medicare Administrative Contractors will start covering the Eversense E3 CGM for people who only take basal insulin.

  • Xray of a man's knee
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    gorodenkoff via Getty Images
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    Robotic knee replacement revision rate no better than traditional surgery: study

    Orthopedics companies such as Stryker and Zimmer Biomet have promoted robotic knee surgery as a more accurate technique.

  • Silhouette of stressed businesswoman in the office.
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    kieferpix via Getty Images
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    Medtech layoffs continue in 2024

    Zimmer Biomet, Illumina and Globus Medical are among the medtech companies that have announced plans to cut jobs this year.

  • Abbott company sign outside
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    Courtesy of Abbott Laboratories

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    FDA meeting document ‘generally supportive’ of Abbott Triclip: analysts

    J.P. Morgan analysts noted the agency’s queries on safety but added the document has “simple voting questions” that “all lean towards approval.”

  • A man using an at-home pulse oximeter.
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    No name give, Prostock-Studio via Getty Images
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    Masimo finds pulse oximeter is accurate in Black patients with low pulse strength

    A recent study, which examined a Masimo device, found low pulse strength and darker skin pigmentation are associated with pulse oximeter errors.

  • Fresenius' corporate headquarters in Bad Homburg, Germany.
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    Courtesy of Fresenius
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    Fresenius brings dialysis technology to US with FDA clearance

    The company plans to start a broad market launch next year and push to establish hemodiafiltration as the new standard of care.

  • Silhouette of stressed businesswoman in the office.
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    kieferpix via Getty Images
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    Livanova to lay off 137 people at Pittsburgh facility

    A spokesperson said the layoffs are part of the company's plan to shut down its advanced circulatory support business.

  • Promotional courtesy shot of a Cue Health Covid-19 test
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    Courtesy of Cue Health Press Kit
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    Cue Health axes more jobs amid declining test sales

    The company cut 94 workers at the beginning of last month and another 151 people on Jan. 25.

  • Thaysen is pictured in a suit and tie.
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    Permission granted by Illumina
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    Illumina cut 12% of global staff over past year: CEO

    The genomics company, which initiated a fresh round of layoffs last month, expects to finalize its Grail divestiture by the end of June, Jacob Thaysen said Thursday.

  • The entrance to Illumina's San Diego campus.
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    Courtesy of Illumina
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    Illumina to lay off 111 people at San Diego headquarters

    The job cuts, expected by March 12, include senior management positions, scientists and engineers.

  • Professional photo of Ivan Tornos
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    Permission granted by Zimmer Biomet
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    Zimmer Biomet to cut about 540 jobs

    A spokesperson told MedTech Dive that the company will lay off about 3% of its workforce as part of a restructuring. 

    Updated Feb. 8, 2024
  • A person sits in front of a plate of food, holding a smartphone. They're wearing a patch on their left arm.
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    Courtesy of Insulet Corp.
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    Insulet wins CE mark for integration of insulin pump with Abbott CGM

    The clearance positions Insulet to sell the integrated Type 1 diabetes product in Europe beginning in the first half of the year.

  • A circular device with a metal mesh around it.
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    Courtesy of Edwards Lifesciences
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    How Edwards’ Evoque valve won an early nod from the FDA

    The heart valve specialist has the chance to shape a new tricuspid market with the first-of-its-kind device, like it did 20 years ago in TAVR, CEO Bernard Zovighian said.

  • Aerial view of a sprawling Boston Scientific manufacturing plant
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    Courtesy of Boston Scientific
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    Boston Scientific’s spinal cord stimulators approved for non-surgical back pain

    FDA backing for the Wavewriter SCS systems allows the company to challenge Abbott and Nevro.

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    Stock via Getty Images
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    Invitae hires advisers, considers bankruptcy: WSJ

    Sources told the Wall Street Journal a bankruptcy filing could come within weeks.