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

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

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

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

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

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

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

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

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

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

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

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

Illumina details EC timeline, funding requirements for Grail divestment

The European Commission ordered the gene sequencing company to support Grail with two-and-a-half years of funding if it pursues a spinoff.

By Susan Kelly • Oct. 13, 2023

European Commission orders Illumina to divest Grail

The order includes an undisclosed timeline and potential additional fines. Illumina, which has been anticipating the decision, maintains the commission does not have jurisdiction over the completed merger.

By Susan Kelly • Oct. 12, 2023

EU poised to mandate Illumina sell Grail liquid biopsy unit: FT

Regulators could order the divestment of the business as soon as next week to punish Illumina for defying their authority and “illegally” acquiring Grail.

By Nick Paul Taylor • Oct. 10, 2023

Insulet wins preliminary injunction against EOFlow in patent suit

A federal judge has blocked EOFlow, a company that Medtronic plans to acquire, from selling its insulin patch pump.

By Susan Kelly • Oct. 9, 2023

Edwards Lifesciences says it was target of surprise EU antitrust inspection

The European Commission announced the action last week without naming the cardiovascular device company.

By Susan Kelly • Sept. 26, 2023

EU antitrust officials make surprise inspections at cardiovascular device company

The unnamed company may have violated EU rules against abusing a dominant market position, the European Commission said.

By Susan Kelly • Sept. 20, 2023

MedTech Europe says MDR, IVDR framework needs ‘structural reform’

Patients may face delayed access to treatments unless changes are made to the new regulatory system, 35 European trade groups warned in an open letter.

By Susan Kelly • Sept. 18, 2023

Walgreens to pay $44M to settle claims over fraudulent Theranos tests

If a judge approves the settlement, patients who bought a Theranos blood test would receive double the amount they paid for it. 

By Elise Reuter • Sept. 8, 2023

Sterigenics’ $408M ethylene oxide settlement removes ‘most problematic’ lawsuits: analysts

Remaining lawsuits pose less of a threat to the medical device sterilizer, and tighter emissions standards seem achievable, KeyBanc analysts wrote. 

By Nick Paul Taylor • Sept. 8, 2023

Bayer faces Essure lawsuit after UK court clears 200 women to claim for damages

Bayer has vowed to defend itself “vigorously” against claims that could cost the company more than $12 million in damages.

By Nick Paul Taylor • Sept. 8, 2023

Philips reaches settlement in US respiratory device litigation

The company will pay more than $479 million to resolve all economic loss claims. The settlement does not include injury or medical monitoring claims. 

By Elise Reuter • Sept. 7, 2023

Medtronic sued for allegedly sharing ‘treasure trove’ of diabetes patient data with Google

The plaintiff said disclosures to Google are “particularly problematic” because his use of Gmail meant his personal information was “automatically linked to his real identity.”

By Nick Paul Taylor • Sept. 5, 2023

3M reaches $6B settlement to resolve combat earplug lawsuits

The agreement is much less than the $10 billion forecast by analysts.

By Nick Paul Taylor • Aug. 29, 2023