Illumina plans to appeal a Federal Trade Commission (FTC) order to divest Grail, a liquid biopsy company that Illumina re-acquired in 2021 (despite ongoing investigations by regulatory agencies in both Europe and the United States) after launching the spinoff four years earlier. Illumina argues that FTC "violated due process by depriving Illumina and Grail of a fair proceeding before an impartial tribunal." Earlier this week media outlets reported that Grail wrongfully told 400 people they might have cancer. The company blamed the error on a vendor, PWN Health, citing a "software configuration issue."
Abiomed is recalling some of its Impella 5.5 heart pumps after reports of fluid leaking from the purge sidearm of the pump. The Impella 5.5 with SmartAssist system is designed to support the pumping chambers of the heart. However, devices with leaks could result in persistent low purge pressure and purge flow, leading to pump stop and loss of therapy, FDA warned.
Masimo and Politan Capital Management continue to trade blows ahead of Masimo's annual shareholder's meeting later this month. Citing "poor governance" and a "collapse in valuation," Politan is trying to get Michelle Brennan and Quentin Koffey elected. Masimo's board said it would appoint Brennan as the company's sixth director, but only if shareholders approve a proposal to expand the board to seven and re-elect incumbent directors Michael Cohen and Julie Shimer. Appointing Brennan would also be under the condition that Koffey, managing partner and chief investment officer at Politan, is not elected. Politan balked at Masimo's offer. Politan has posted its presentation, proxy materials, and letter to shareholders on its campaign site. The company's proxy materials are posted on Masimo's campaign site.
And in case you missed our last Medtech in a Minute report...
Titan has granted Intuitive Surgical a non-exclusive license to all of its intellectual property (IP), with the exception of the IP that is exclusively licensed to another party under a June 2020 license agreement. Cary Vance, Titan's president and CEO. has also agreed to step down from the position, but will remain on the board. Paul Cataford, the board’s chair, will become interim president and CEO. The surgical robotics company first showed signs of trouble in 2019 when it delayed development of its single-port robotic system twice due to a lack of financing. But the writing on the wall really became clear in December as Titan Medical began reviewing strategic alternatives. In February the company, which was already down to a skeleton crew, let go of four members of its leadership team.
Philips has agreed to pay $62 million to resolve charges that it violated the Foreign Corrupt Practices Act over its conduct related to sales of medical equipment in China. The company's subsidiaries in China are accused of using special price discounts with distributors that created a risk that excessive distributor margins could be used to fund improper payments to government employees. An investigation also points to the company's employees engaging in improper conduct to influence hospital officials to draft technical specifications in public tenders to favor Philips’ products in China.
Cook Medical is cutting 500 positions in an effort to refocus efforts on product innovation. The company was quick to note, however, that none of its hourly manufacturing employees or hourly employees at distribution centers will be impacted. Cook said demand for its products continues to grow and the company wants to ensure it has the capacity to meet that demand.