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June 16, 2023
2 Min Read
Philips is dealing with yet another Class I recall. The company is instructing Trilogy Evo ventilator users to change filters more frequently to prevent device malfunction. Of note, use of the filter was previously seen as optional by the company. Philips initially notified FDA in April of a potential issue with the ventilator family where extended environmental contamination exposure could affect the devices air path.
Surmodics struck out on its first attempt to win FDA approval for the highly-anticipated SurVeil drug-coated balloon when the company received a letter from the agency that its premarket approval (PMA) application for the device was not approvable. The Eden Prairie, MN-based company submitted an amended PMA application in May, however, and this second swing just might be the home run investors have been hoping for.
Siemens Healthineers laid off 67 employees at a diagnostics facility in Flanders, NJ that will go into effect on Sept. 7. The facility, which supports 800 employees, is reportedly shutting down its Atellica Solution Immunoassay module manufacturing as it consolidates it to its Swords site in Dublin, Ireland.
And in case you missed our last Medtech in a Minute report...
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.
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