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Home » Topics » Regulatory

Regulatory
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Stereotaxis robotic magnetic navigation (RMN) system

Stereotaxis begins anew with Genesisx launch in EU

Jan. 30, 2025
By Annette Boyle
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.
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Artificial intelligence and digital health icons

EU trade associations call for withdrawal of AI Liability Directive

Jan. 30, 2025
By Mark McCarty
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.
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Eyebright Meiyue Tong TOPPOP Smart store

‘Little giant’ Eyebright’s phakic IOL cleared for myopia in China

Jan. 30, 2025
By Marian (YoonJee) Chu
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.
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FDA diversity-in-trials rules evaporate after ‘strident’ Trump EO

Jan. 29, 2025
By Randy Osborne
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.
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Illustration of polycystic kidney

Regulus heads to phase III after more positive kidney disease data

Jan. 29, 2025
By Jennifer Boggs
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.
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RFK Senate hearing 1-29-25

Confirmation hearings begin for RFK as US HHS secretary

Jan. 29, 2025
By Mari Serebrov
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.
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FCA cases reach new high in 2024, but value of recoveries no outlier

Jan. 29, 2025
By Mark McCarty
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.
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Judge's gavel with US flag

Illumina, Molecular Loop square off over patents for NGS systems

Jan. 29, 2025
By Mark McCarty
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.
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Flag of Australia, sky background

TGA posts draft guidance for non-mandatory application audits

Jan. 29, 2025
By Mark McCarty
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.
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Art concept for molecular glue degradation
Cancer

Seed’s RBM39 degrader awarded US orphan drug, rare pediatric disease designations

Jan. 29, 2025
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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