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BioWorld - Monday, February 16, 2026
Home » Topics » Regulatory, Medical technology

Regulatory, Medical technology
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CMS logo and website

CMS finalizes plan to do away with inpatient-only list

Nov. 24, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services released the 1657-page final rule for inpatient payment for calendar year 2026, a document chock full of important policy decisions including a renewed call for elimination of the inpatient-only list.
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Female doctor and patient
FT Global Pharma and Biotech Summit

Could restricting diversity efforts stall women’s health research?

Nov. 21, 2025
By Nuala Moran
No Comments
Recent progress in redressing the historical underfunding and neglect of women’s health could be undermined by the backlash against diversity, equity and inclusion (DEI) initiatives, according to executives participating in the FT Global Pharma and Biotech Summit 2025 in London Nov. 11-12.
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CDC logo on website

RFK skirts promise as CDC alters vaccine-autism webpage

Nov. 21, 2025
By Karen Carey
No Comments
Changes to a U.S. CDC website regarding autism and vaccines has sparked a backlash from numerous scientific and other groups, placing HHS Secretary Robert F. Kennedy Jr. (RFK) in the spotlight once again for appearing to break promises made earlier this year to secure his nomination.
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In virtro fertilization

Overture Life receives CE mark for Davitri platform

Nov. 21, 2025
By Shani Alexander
Overture Life SLU secured CE mark certification for its Davitri system that automates the vitrification and thawing of oocytes and embryos, making the processes more efficient, consistent and cost-efficient. Davitri has the potential to transform IVF, giving women and families more control over their fertility timelines and ensuring every egg and embryo has the best possible chance of survival.
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Probiotics, bacteria on white background
Gastrointestinal

UK study reveals inconsistencies in global microbiome research

Nov. 21, 2025
By Nuala Moran
No Comments
The U.K. Medicines and Healthcare products Regulatory Agency is calling for unified standards to harmonize microbiome research, after revealing major inconsistencies in the results when labs around the world analyzed identical reference samples of gut bacteria.
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Lungs

Bayer’s HER2-mutated lung cancer treatment gets FDA nod

Nov. 20, 2025
By Lee Landenberger
No Comments
A new oral HER2-directed breast cancer therapy from Bayer AG, and its companion diagnostic from Thermo Fisher Scientific Inc., have been approved by the U.S. FDA. Hyrnuo (sevabertinib), a reversible tyrosine kinase inhibitor, was greenlit by the agency for adults with locally advanced or metastatic non-squamous advanced HER2-mutant non-small-cell lung cancer.
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US Capitol at night

PAMA cuts for clinical lab testing averted, but overhang remains

Nov. 20, 2025
By Mark McCarty
The resolution of the budget impasse between Democrats and Republicans on Capitol Hill sidestepped a number of problems, including some cuts to Medicare payment rates for clinical laboratory testing services. However, that pause is only in effect through the end of January 2026, leaving operators of these labs with a fiscal sword of Damocles to manage.
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Diamond cut, ombre EU flag

European Commission eyes delayed compliance dates for AI Act

Nov. 19, 2025
By Mark McCarty
The European Commission posted a series of proposed legislative updates, including the AI Act, which might not come into force for the med tech industry until August 2028 under the terms of this proposal.
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Judge's gavel with US flag

Aesculap clears its legal troubles with $38.5M OIG settlement

Nov. 18, 2025
By Mark McCarty
Aesculap Implant Systems LLC has seen its share of bad news recently, but the company seems to have cleared the legal deck with an agreement to pay $38.5 million per a Nov. 17 announcement by the U.S. attorney’s office for the district of Eastern Pennsylvania.
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Dollar sign dropper and test tube

Scrutiny of NIH funding cuts, potential retaliation continues

Nov. 17, 2025
By Mari Serebrov
No Comments
Over a span of five-and-a-half months this year, 3.5% of the more than 11,000 clinical trials funded by the U.S. NIH had their grants terminated, according to an article published in the Nov. 17 JAMA Internal Medicine. That’s 383 trials that lost funding.
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