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

Illumina appeals FTC’s order to divest Grail with plea for cancer screening test

The DNA-sequencing company that has been fighting regulators over orders to reverse its 2021 acquisition of Grail is accusing the U.S. government of overreach and collusion with European regulators.

By Susan Kelly • June 6, 2023

Precision Lens ordered to pay $487M for kickbacks to eye surgeons in Medicare false-claims case

Luxury vacations and tickets to Broadway shows were used by the Minnesota-based ophthalmologic supply company to induce surgeons to use its products, a federal court ruled. 

By Elise Reuter • May 19, 2023

ITC to review ruling that Apple violated Masimo’s patents

If the ITC finds Apple improperly used Masimo’s pulse oximetry technology in the Apple Watch, the commission could ban imports of some Watch versions.

By Elise Reuter • May 17, 2023

Philips agrees to pay SEC more than $62M to settle China corruption charges

Resolving charges that employees, distributors and subsidiaries may have engaged in improper bidding in China lets Philips put the issue behind it without admitting guilt.

By Susan Kelly • May 12, 2023

Philips loses vote as shareholders push back against handling of respirator recall

The vote will allow investors to sue board members over their actions in 2022. Philips blamed the ballot loss on guidance from proxy advisors.

By Nick Paul Taylor • May 10, 2023

Masimo suit against Apple over smartwatch trade secrets ends in mistrial

The medical device maker said it intends to retry the lawsuit, as it awaits a decision from the International Trade Commission on a separate investigation into patent infringement claims against Apple.

By Susan Kelly • May 2, 2023

Lawsuit accuses J&J subsidiary of selling faulty knee replacements

A patient who had DePuy’s Attune knee system implanted, and then replaced when it loosened, claims the company downplayed the risks of the device.

By Elise Reuter • Updated April 21, 2023

Pear Therapeutics files for Chapter 11 bankruptcy

The maker of subscription apps for insomnia and substance abuse began exploring strategic alternatives earlier this month, and is still seeking a sale.

By Elise Reuter • April 7, 2023

Diagnostics execs charged with concealing lead test flaw

The former CEO and two other top executives of Magellan Diagnostics are accused of hiding a malfunction that caused tens of thousands of children and adults to receive inaccurately low lead test results.

By Susan Kelly • Updated April 5, 2023

Illumina ordered to divest Grail by FTC on anticompetition concerns

The San Diego-based DNA-sequencing company, which also faces a challenge from European antitrust regulators, said it will appeal the FTC’s order.

By Susan Kelly • April 3, 2023

Philips CEO Jakobs expects first settlement on respirators this year, Dutch newspaper says

Jakobs said he “hopes and expects” to reach a settlement with the Food and Drug Administration this year; settling suits over alleged medical damages may take longer.

By Peter Green • March 31, 2023

Medtech groups lose challenge to digital piracy rule in device repair case

Repair companies will still be able to access and use operating code to fix medical devices, after the court rejected arguments by AdvaMed and the Medical Imaging & Technology Alliance.

By Susan Kelly • March 13, 2023

Friday Q&A: A regulatory attorney breaks down the EU MDR transition

Amsterdam-based regulatory expert Erik Vollebregt explains the agreement this week to extend the deadlines to comply with the EU’s Medical Device Regulation, and the issues that still need to be addressed.

By Susan Kelly • March 10, 2023

Ex-medtech CEO arrested over alleged scheme to sell dummy devices, defraud Medicare

Prosecutors accuse the former Stimwave CEO of engaging in a multi-year scheme to sell a device with no medical purpose for implantation into chronic pain patients.

By Nick Paul Taylor • March 10, 2023

AdvaMed calls Europe’s MDR extension a ‘strong step forward,’ but warns challenges remain

The extra time to certify medical devices in Europe is intended to prevent shortages, but the regulatory overhaul still poses problems for medtech firms, the U.S. lobbying group says.

By Susan Kelly • March 7, 2023

Medtech industry relieved as Europe’s MDR extension nears final approval

While the extra time to comply is aimed at preventing medical device shortages, the rules have still left some device makers and certifying bodies unclear about how to proceed, says one attorney.

By Susan Kelly • March 6, 2023

AliveCor says enforcement of Apple Watch import ban may take more than a year

The Biden administration upheld findings that Apple violated AliveCor’s patents, but a potential import ban rests on the outcome of a separate appeal, which could take several months.

By Elise Reuter • Feb. 22, 2023

J&J loses bid for Supreme Court review of $302M vaginal-mesh verdict

The justices’ decision to let a lower court verdict stand leaves the company subject to varying state liability laws, J&J says.

By Peter Green • Feb. 21, 2023

Applied Medical suit against Medtronic alleges surgical-device bundling practice curbs competition

Applied says in its filing that Medtronic “has conspired” to bundle devices for cutting tissue and sealing vessels “in a way that is unhealthy for competition.”

By Nick Paul Taylor • Updated Feb. 16, 2023

Alcon to pay J&J $199M to settle dispute over patents for laser eye surgery device

Alcon is settling the case for far less than the $3.1 billion that J&J’s damages expert argued the company could be owed.

By Nick Paul Taylor • Feb. 14, 2023

Medtronic ordered by jury to pay $106.5M to Colibri over TAVR patent infringement

Medtronic says the ruling will have no effect on its TAVR business as the patents expired last year and it vowed to appeal the verdict. 

By Nick Paul Taylor • Updated Feb. 14, 2023

Invacare files for Chapter 11 bankruptcy protection amid supply chain woes

The wheelchair maker said it has reached a restructuring agreement with most of its debt holders and that demand for its products remains strong.

By Susan Kelly • Updated Feb. 3, 2023

FTC orders GoodRx to stop sharing users’ health data with advertisers, issues $1.5M fine

Regulators said they are putting the industry on watch with the enforcement against GoodRx, which allegedly collected data, including patient medications, and shared it without user consent.

By Rebecca Pifer • Updated Feb. 1, 2023