Legal: Page 2
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Pathology group sues to block FDA lab test rule
The Association for Molecular Pathology is the second lab trade group urging the courts to void an FDA policy expanding oversight of diagnostic tests.
By Susan Kelly • Aug. 30, 2024 -
Retrieved from Masimo on August 20, 2024
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 Susan Kelly • Aug. 21, 2024 -
Karen Ducey/Getty Images via Getty Images
Experts fear patient harm from FDA’s lab developed test rule
Decreased access to diagnostic tests, worsening patient care and practice closures are among the concerns the AMA and others have raised as the regulation takes effect.
By Susan Kelly • Aug. 5, 2024 -
Courtesy of Philips
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 Elise Reuter • Aug. 2, 2024 -
Courtesy of Business Wire
Guardant settles allegations it violated the False Claims Act
The settlement resolves claims that an oncologist ordered significantly more tests after Guardant hired two people the physician recommended for jobs at the company.
By Nick Paul Taylor • July 23, 2024 -
Masimo sues activist investor Politan, postpones annual meeting
The latest turn in the recent drama comes days after proxy advisory firms ISS and Glass Lewis backed two Politan nominees for Masimo’s board.
By Susan Kelly • July 16, 2024 -
Anna Moneymaker / Staff via Getty Images
Deep DiveFDA’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 Susan Kelly , Elise Reuter • July 11, 2024 -
Courtesy of Roche
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 Nick Paul Taylor • July 3, 2024 -
Retrieved from Dermtech on June 20, 2024
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 Nick Paul Taylor • June 20, 2024 -
David McNew via Getty Images
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 Nick Paul Taylor • June 20, 2024 -
Kevin Dietsch / Staff via Getty Images
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 Susan Kelly • June 13, 2024 -
GussWilder for iStock via Getty Images
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 Elise Reuter • June 11, 2024 -
K-Kwanchai via Getty Images
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 -
N/A via Getty Images
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 -
RiverNorthPhotography via Getty Images
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 -
Kuzma via Getty Images
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 -
Stock via Getty Images
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
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