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

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