Continuing a cascade of positive news for Stereotaxis Inc., the company reported the first order for its petite Genesisx robot in Europe. The system received CE mark in August, but management held off its launch until its Magic radiofrequency ablation catheter also received CE mark, which happened on Jan. 27. The two devices are used together to treat cardiac arrhythmias.
The EU has moved aggressively on legislation in recent years, with the AI Liability Directive serving as the latest example of legislation that sparked widespread opposition.
Eyebright Medical Technology (Beijing) Co. Ltd. is expanding its position in China’s phakic intraocular lens (IOL) market, gaining the National Medical Products Administration (NMPA) approval of its Loong Crystal PR phakic IOL product for myopia in adults in January 2025.
President Donald Trump’s recently issued executive order (EO) putting a stop to diversity, equity, and inclusion programs in the U.S. government is sending ripples far and wide, into areas that some might not have anticipated. The FDA has taken down from its website the guidelines regarding action plans related to achieving diversity in clinical trials.
In an indication that has proved difficult for biopharma to conquer, Regulus Therapeutics Inc. disclosed further positive data from its ongoing phase Ib study testing RGLS-8429 in autosomal dominant polycystic kidney disease and laid out its plans to move straight into a phase III trial later this year, with the potential for an accelerated U.S. approval.
In a U.S. Senate Finance Committee confirmation hearing marked by shouted protests, outbursts of applause and tense exchanges on several issues, including ones beyond the reach of the Department of Health and Human Services (HHS), Robert F. Kennedy Jr. (RFK) tried to present himself as someone who follows the science, not a conspiracy theorist or anti-vaxxer.
False Claims Act litigation in the U.S. spiked significantly according to a new report by Gibson, Dunn & Crutcher, LLP, at least in terms of the number of cases brought to the courts. However, the report added that the total dollar value of these cases is in line with historical norms, suggesting that the average recovery amount has tapered off significantly.
While the U.S. Supreme Court sidelined itself over patent issues such as subject matter eligibility, the diagnostic patent wars are still in full swing as a casual review of cases at the U.S. Patent and Trademark Office discloses.
Australia’s Therapeutic Goods Administration posted a draft guidance dealing with non-mandatory audits for premarket applications, which says that a transcatheter aortic valve replacement device that has been approved by the U.S. FDA may not be subject to such an audit.
Seed Therapeutics Inc.’s ST-01156 has been awarded orphan drug designation for the treatment of Ewing sarcoma as well as rare pediatric disease designation by the FDA.
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