Legal


  • Loper decision ending Chevron deference doctrine
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    Deep Dive

    FDA’s lab developed test rule could be first check on agency’s power post-Chevron

    The Supreme Court’s decision to overturn the Chevron doctrine would make it easier to challenge agency regulations, such as the LDT final rule.

    By , July 11, 2024
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    Courtesy of Roche
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    Roche sues Foresight and Stanford, alleging use of trade secrets

    Roche said Stanford applied for patents relating to cancer detection and monitoring technology using its confidential information.

    By July 3, 2024
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    Retrieved from Dermtech on June 20, 2024
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    Dermtech files for Chapter 11, lays off 20% of staff

    The diagnostic test maker will continue to hunt for a buyer for its skin cancer detection patch.

    By June 20, 2024
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    David McNew via Getty Images
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    Former Stimwave CEO gets 6 years in prison for fake device scheme

    The case centered on allegations that Stimwave marketed a dummy piece of plastic as a receiver of radiofrequency energy.

    By June 20, 2024
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    Kevin Dietsch / Staff via Getty Images
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    Masimo embroiled in dual DOJ, SEC probes

    Masimo will have to juggle the government inquiries while also dealing with an activist investor-led proxy battle.

    By June 13, 2024
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    GussWilder for iStock via Getty Images
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    Vyaire Medical files for Chapter 11 bankruptcy

    CEO John Bibb said the move gives Vyaire “breathing room” as the ventilator manufacturer looks to sell its businesses.

    By June 11, 2024
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    K-Kwanchai via Getty Images
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    Lab industry sues to stop FDA’s new LDT rule

    The American Clinical Laboratory Association argues the agency does not have the authority to enforce stricter standards on lab developed tests.

    By May 30, 2024
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    N/A via Getty Images
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    Philips reaches major settlements related to respiratory devices recall

    A judge recently finalized an economic claims settlement, and Philips said it reached an agreement on medical claims.

    By May 2, 2024
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    Courtesy of Philips
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    Judge approves settlement of more than $500M from Philips recall

    Philips could be on the hook for more costs if eligible claims for recalled or returned respiratory devices exceed the amount agreed to in the settlement.

    By April 25, 2024
  • EU antitrust enforcement, Apple, Meta, Alphabet
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    Sean Gallup via Getty Images
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    EU launches probe of China’s medical device market

    China’s procurement market for medical devices has gradually become more closed for European and foreign companies, the European Commission alleges.

    By April 24, 2024
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    RiverNorthPhotography via Getty Images
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    FTC votes to ban noncompetes, with far-reaching effects on doctors

    The FTC estimates the final rule would lower healthcare costs by $194 billion over the next decade, while freeing up physicians to more easily move between employers.

    By Rebecca Pifer • April 24, 2024
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    Courtesy of Grail
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    European Commission approves Illumina’s proposed Grail split

    Selling Grail to a third party would free Illumina of the need to capitalize the company, but the buyer would need the commission’s approval, analysts wrote.

    By April 15, 2024
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    Courtesy of Philips
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    Philips restricted from selling respiratory machines in DOJ consent decree

    The agreement, filed Tuesday, also has export restrictions to ensure U.S. patients receive remediated devices in a timely manner.

    By April 9, 2024
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    Courtesy of Illumina
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    Court adviser sides with Illumina in EU row that triggered Grail fine

    Illumina is still planning to divest Grail but may escape a fine of about 432 million euros imposed by the European Commission.

    By March 25, 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 claims win in Axonics patent row, pushes for jury trial

    New rulings from a U.S. patent appeal board are the latest step in the companies’ intellectual property dispute over sacral neuromodulation devices.

    By March 22, 2024
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    Rick Loomis via Getty Images
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    Former Stimwave CEO found guilty of selling fake implantable device component

    The former executive was convicted on two counts for her role in creating and marketing the faulty devices.

    By March 8, 2024
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    Courtesy of Medtronic
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    Medtronic asks ITC to stop sales, imports of Axonics devices

    The complaint is the latest move in a long-running patent fight between the two companies regarding neuromodulation devices.

    By March 1, 2024
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    Kuzma via Getty Images
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    Ex-Mazor exec convicted of insider trading conspiracy linked to $1.6B Medtronic deal

    A federal jury found Doron Tavlin guilty on one count of conspiracy to commit insider trading and 10 counts related to securities fraud.

    By Feb. 22, 2024
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    Invitae hires advisers, considers bankruptcy: WSJ

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

    By Feb. 7, 2024
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    Courtesy of Philips
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    Philips consent decree ‘worst case scenario’ for respiratory business

    The company may have to demonstrate years of compliance before it can sell sleep and respiratory products in the U.S. again, experts said.

    By Feb. 6, 2024
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    Patrik Stollarz / Staff via Getty Images
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    Philips stops selling sleep, respiratory devices in US due to FDA consent decree

    The order is now being finalized ahead of its submission to a U.S. court for approval.

    By Jan. 29, 2024
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    Sascha Steinbach via Getty Images
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    How Masimo forced Apple to redesign its smartwatches

    In a long-running patent dispute, Masimo has compelled the tech giant to remove the pulse oximetry function of certain Apple Watches.

    By Jan. 26, 2024
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    Eric Thayer via Getty Images
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    Apple, locked in patent fight with Masimo, redesigns smartwatch

    The tech giant could bring to market watches without a pulse oximetry feature to avoid an ITC ban on sales of versions now on the market.

    By Jan. 16, 2024
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    Justin Sullivan via Getty Images
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    Apple Watch sales resume after latest twist in Masimo patent case

    An appeals court has granted Apple’s emergency motion to pause the U.S. International Trade Commission’s ban on sales of its watches with a pulse oximetry feature.

    By Jan. 3, 2024
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    Drew Angerer via Getty Images
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    SEC charges former Stimwave CEO with $41M fraud scheme

    The Securities and Exchange Commission alleges that Laura Tyler Perryman approved the creation of “fake” implantable parts for the company’s PNS device and defrauded investors of $41 million.

    By Dec. 21, 2023