The Latest
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CAP urges HHS to revoke lab developed test rule, citing Trump order
The pathologists group wants the regulation terminated in light of an executive order from President Trump that calls for federal agencies to “alleviate unnecessary regulatory burdens.”
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Quest to buy Fresenius Medical Care kidney testing assets
The acquisition will add dialysis-related water testing to Quest’s portfolio and position the company to perform the tests and other end-stage kidney disease services for Fresenius Medical Care.
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Thermo Fisher to buy Solventum’s purification and filtration unit for $4.1B
Wall Street applauded the deal, sending shares of Solventum, the 3M spinoff, up 10% on Tuesday.
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FDA brings back some fired device staff
An industry source said “most, if not all” of the people at the CDRH who were recently dismissed are now being asked to return.
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Boston Scientific pacemaker recall tied to 832 injuries, 2 deaths
Certain Accolade pacemakers can permanently enter safety mode, which limits the devices’ ability to treat patients properly and requires early replacement.
Updated Feb. 25, 2025 -
Medtronic gains FDA OK for self-adjusting DBS system for Parkinson’s
The brain-computer interface technology personalizes therapy based on an individual’s brain activity.
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Guardant accuses Natera of poaching employees, stealing trade secrets
The lawsuit claims Natera aggressively recruited bioinformatics scientists from Guardant to “jumpstart its lagging position in the early cancer test industry.”
Updated Feb. 25, 2025 -
VitalConnect raises $100M for heart monitor patch
VitalConnect will use the money to commercialize the monitor, which detects arrhythmias and competes with patches from companies including iRhythm.
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After tough year, Baxter looks for next CEO to drive growth
Interim CEO Brent Shafer said the medical products maker is ready to begin a new era after several years of “heavy lifting” to simplify the business structure.
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Device industry scrambles as FDA job cuts cause delays
The cuts at the FDA’s device center could add “months, if not years” to the time it takes to bring products to market, an attorney said.
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In FDA job cuts, experts see threat of far-reaching impact
"Any place that gets cut, it's going to have an impact, because there's not any spare personnel at FDA,” said former agency commissioner Robert Califf.
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Siemens Healthineers opening logistics depots in US to boost inventory
Expanding parts inventory and logistics capabilities will support later cutoff times, same-day delivery within 300 miles and more next-flight-out options for customers, the company said.
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FTC retains stricter merger guidelines under Trump
FTC Chair Andrew Ferguson sent a memo to agency staff on Tuesday clarifying that the Biden-era guidelines will remain in place — for now.