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

US signs consent decree requiring EPA to finalize ethylene oxide rule by March

A medtech trade group called the deadline inadequate for the EPA to complete the “substantial” work that remains.

By Nick Paul Taylor • Aug. 28, 2023

Insulet claims EOFlow copied patch-pump design in patent suit

Insulet filed the lawsuit as competitor Medtronic plans to buy EOFlow for $738 million.

By Elise Reuter • Aug. 15, 2023

Medtronic’s bid to dismiss heart device kickback claims fails, clearing case to advance

A whistleblower accused Medtronic of violating the False Claims Act by billing the government for unnecessary medical procedures.

By Nick Paul Taylor • Updated Aug. 15, 2023

Guardant, Illumina agree to end litigation, extend commercial partnership

The two sides will now renew a long-term collaboration to advance cancer research, Guardant said.

By Susan Kelly • Aug. 8, 2023

Pressure mounts for Illumina to divest Grail amid record fine, executive changes

Illumina is facing a 432 million euro fine from European regulators and is looking for a new CEO.

By Elise Reuter • Aug. 8, 2023

Appeals court overturns ruling in Axonics-Medtronic neurostim patent dispute

The court said the patent board’s “refusal to consider the new arguments and evidence was erroneous.” 

By Nick Paul Taylor • Aug. 8, 2023

Augmedics picks up Surgalign’s digital health assets for $900K

Surgalign is selling its assets under court supervision after filing for Chapter 11 bankruptcy protection.

By Susan Kelly • Aug. 1, 2023

Regulatory specialist pleads guilty to forging FDA clearance letters

The former employee of B. Braun’s Aesculap division admitted creating the letters on FDA letterhead and forging an agency official’s digital signature.

By Susan Kelly • July 26, 2023

Court allows Axonics neurostim patent case to proceed against Medtronic

A federal appeals court found that a U.S. Patent Office board erred in its legal analysis of the challenge to Medtronic’s neurostimulation patents.

By Susan Kelly • Updated July 17, 2023

US trade body again delays decision on Apple-Masimo patent dispute

A potential settlement or royalty payments stemming from Masimo’s claim that Apple’s pulse oximetry features infringed on its patents could offer “significant upside” for Masimo, BTIG analysts wrote.

By Nick Paul Taylor • July 13, 2023

FTC intervenes to correct Medtronic’s ‘erroneous assertions’ in antitrust case

The FTC filed an amicus brief because it said Medtronic made “wrong” arguments with “broad implications for antitrust enforcement.”

By Nick Paul Taylor • July 6, 2023

Former J&J sales rep indicted on charges of defrauding Boston hospital

The former J&J employee is accused of bilking the hospital out of hundreds of thousands of dollars’ worth of spine products.

By Susan Kelly • June 28, 2023

Surgalign files for bankruptcy, agrees to sell US hardware unit for $5M

Surgalign also disclosed that it is laying off 25 employees and eliminating the position of chief commercial officer.

By Nick Paul Taylor • June 21, 2023

Philips gets slapped with two legal challenges by French patients in ‘Respiratorgate’

A civil case covers 1,341 claimants who seek compensation for non-material damages tied to a failure to provide adequate information and for what they say is anxiety-related harm.

By Nick Paul Taylor • Updated June 22, 2023

The importance of trust in AI as a medical device

Building trust with patients, as well as regulators, will be key to the adoption of AI in medical devices and diagnostics, argues Alison Dennis, a London-based partner with law firm Taylor Wessing.

By Alison Dennis • June 15, 2023

Teleflex prevails in Medtronic’s appeal over guide catheter patents

A federal appeals court judge denied Medtronic’s claims that Teleflex’s catheters were unpatentable.

By Elise Reuter • Updated June 7, 2023