Legal: Page 4
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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 Susan Kelly • May 30, 2024 -
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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 Elise Reuter • May 2, 2024 -
Courtesy of Philips
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 Elise Reuter • April 25, 2024 -
Sean Gallup via Getty Images
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 Susan Kelly • April 24, 2024 -
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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 -
Courtesy of Grail
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 Nick Paul Taylor • April 15, 2024 -
Courtesy of Philips
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 Elise Reuter • April 9, 2024 -
Courtesy of Illumina
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 Nick Paul Taylor • March 25, 2024 -
Courtesy of Medtronic
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 Nick Paul Taylor • March 22, 2024 -
Rick Loomis via Getty Images
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 Susan Kelly • March 8, 2024 -
Courtesy of Medtronic
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 Nick Paul Taylor • March 1, 2024 -
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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 Nick Paul Taylor • 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 Susan Kelly • Feb. 7, 2024 -
Courtesy of Philips
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 Elise Reuter • Feb. 6, 2024 -
Patrik Stollarz / Staff via Getty Images
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 Nick Paul Taylor • Jan. 29, 2024 -
Sascha Steinbach via Getty Images
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 Susan Kelly • Jan. 26, 2024 -
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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 Susan Kelly • Jan. 16, 2024 -
Justin Sullivan via Getty Images
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 Susan Kelly • Jan. 3, 2024 -
Drew Angerer via Getty Images
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 Ricky Zipp • Dec. 21, 2023 -
Justin Sullivan via Getty Images
Apple to pause US sales of smartwatches with pulse oximetry
The tech giant’s move follows a USITC ruling that found the watches infringed some of Masimo's patents for measuring blood oxygen.
By Susan Kelly • Dec. 20, 2023 -
Courtesy of ResMed
Resmed hails ‘significant victory’ as patent board rules in dispute with NYU
The decisions invalidate claims that NYU argued were infringed by Resmed’s sleep apnea devices.
By Nick Paul Taylor • Dec. 14, 2023 -
Courtesy of Johnson & Johnson
J&J hernia mesh settlement prompts judge to dismiss more than 200 cases
The company and claimants in Georgia filed to dismiss cases related to Ethicon’s Physiomesh in late November.
By Nick Paul Taylor • Dec. 6, 2023 -
Permission granted by Philips
Philips leader signed off on sale of respiratory devices despite evidence of health risks: report
Roy Jakobs approved the sale of respiratory devices held by manufacturers after the company stopped shipping new machines, according to an article published last week by Pittsburgh Post-Gazette and ProPublica.
By Nick Paul Taylor • Oct. 30, 2023 -
Courtesy of Illumina
Icahn sues to remove Illumina board members, asks for at least $476M in damages
The activist investor claims board members breached their duties in the acquisition of Grail.
By Nick Paul Taylor • Oct. 24, 2023 -
Scott Olson via Getty Images
US trade commission explores impact of patent rules on COVID diagnostics
The USITC report presents conflicting testimony from the medtech industry and advocacy groups about the impact of compulsory licensing.
By Nick Paul Taylor • Oct. 23, 2023
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