Advamed CEO congratulates Trump, stresses need for public policy support

Donald Trump’s election victory comes weeks after the FDA named a new leader for the medical device center and as the agency’s contentious LDT final rule is challenged in court.

By Ricky Zipp • Nov. 11, 2024

Medtronic settles pulse oximetry lawsuit alleging inaccuracies

Roots Community Health has sued 12 other firms, including GE Healthcare, CVS and Walgreens, and called for manufacturers and the FDA to ensure the devices work for everyone.

By Elise Reuter • Nov. 4, 2024

Exactech files for Chapter 11, agrees to investor buyout

The filing follows Exactech’s failure to settle product liability claims from about 2,600 patients in response to recalls of orthopedic devices.

By Nick Paul Taylor • Oct. 30, 2024

FTC increases premerger reporting requirements over provider objections

Companies will be required to disclose more information about minority investors and past M&A activity. Provider groups said the new requirements would be burdensome for hospitals.

By Susanna Vogel • Oct. 16, 2024

Independent lab fires back after Philips sues over testing results

PSN Labs called for a jury trial, claiming Philips is attempting to deflect attention away from its own “failures, negligence, concealment and recklessness.”

By Elise Reuter • Oct. 3, 2024

BD agrees to settle most of its hernia mesh litigation

The settlement terms are confidential, BD said. The company disputes the lawsuit’s allegations and backs its product designs.

By Susan Kelly • Oct. 3, 2024

Jury sides with Axonics in Medtronic patent dispute

Meanwhile, Boston Scientific is still waiting for antitrust regulators to conclude their review of its proposal to buy Axonics, which was announced in January.

By Elise Reuter • Sept. 19, 2024

Masimo proxy fight nears end as shareholder vote looms

Chairman and CEO Joe Kiani’s board seat is on the line at today's shareholder meeting.

By Susan Kelly • Sept. 19, 2024

Illumina court ruling limits EU regulators’ merger review power

The European Commission lacked oversight authority to examine the proposed sale of a cancer-detection company to biotech company Illumina, the court found.

By Justin Bachman • Sept. 9, 2024

Judge orders J&J to pay Auris investors more than $1B for merger violations

J&J did not provide Auris Health with resources to achieve regulatory milestones after acquiring the robotics company in 2019, the judge found.

By Ricky Zipp • Sept. 6, 2024

Illumina avoids fine for Grail purchase in European court victory

Illumina will avoid a penalty of 432 million euros after a court ruled the European Commission did not have jurisdiction to challenge the company’s Grail acquisition.

By Susan Kelly • Sept. 3, 2024

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

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

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

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

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

FDA’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

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

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

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

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

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

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

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