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BioWorld - Tuesday, January 20, 2026
Home » Topics » North America » U.S.

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GE Healthcare

GE Healthcare touts ‘first-of-its-kind’ all-digital PET/CT system

Oct. 27, 2022
By David Godkin
GE Healthcare has introduced an all-digital PET/CT System featuring a new category of digital BGO (crystal-based gamma ray detection) employing a smaller crystal size to deliver greater spatial resolution than other digital scanners. Pitched at the European Association of Nuclear Medicine’s annual meeting in Barcelona on Oct. 16, Omni Legend was designed to accelerate scan times and has demonstrated, according to GE Healthcare global chief marketing officer Sonia Sahney, “impressive small lesion detectability.”
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U.S. Capitol building, Washington D.C.
2022 Medtech Conference

US Senate seen as more likely than House to push for quick passage of VALID Act

Oct. 26, 2022
By Mark McCarty

The U.S. FDA’s interest in regulating lab-developed tests (LDTs) occasionally prompts the agency to engage in a little saber-rattling about rulemaking if Congress should fail to pass legislation granting the FDA explicit authority to regulate these tests. 


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2022 Medtech Conference

Recent case law suggests a need to take care in use of consultant physicians

Oct. 25, 2022
By Mark McCarty
Device makers often need the assistance of physicians to aid in device design and development, but this is a practice that comes with some legal hazards. A session held here in Boston on enforcement in the U.S. made clear that manufacturers must exercise caution in these consulting arrangements, such as documenting the need for outside help with the device, lest the manufacturer end up with a hefty, multimillion-dollar fine imposed by U.S. enforcement agencies.
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Mycobacterium tuberculosis
Infection

IDWeek 2022: Infection prevention during latent diseases

Oct. 24, 2022
By Mar de Miguel
At the Saturday, Oct. 22 session, ‘Basic Science: Correlates of protection, immune response and the host-microbe interaction,’ of the IDWeek 2022 infectious disease conference, moderator Luiz Bermudez, professor at Oregon State University, introduced the latest advances to prevent infections with Treponema pallidum during neurosyphilis (NS), Staphylococcus aureus and osteomyelitis, and Mycobacterium tuberculosis during influenza.
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Hand holding lightbulb

Spinoffs keep up dizzying pace with Medtronic separation

Oct. 24, 2022
By Annette Boyle
After years of aggressive acquisitions, Medtronic plc joined 3M Co., General Electric Co. and Johnson & Johnson in rationalizing its business by splitting into more focused enterprises. Medtronic will separate its patient monitoring and respiratory therapy groups into a new company with projected annual revenue of $2.2 billion and 8,000 employees in the next 12 to 18 months, assuming regulatory and final board approvals.
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Liver tumor treatment conceptual illustration

Approval at last, but can Astrazeneca’s tremelimumab hit Stride in liver cancer?

Oct. 24, 2022
By Jennifer Boggs
It’s been a long road, but Astrazeneca plc’s anti-CTLA4 antibody, tremelimumab, finally earned its first U.S. FDA nod, cleared for use in combination with anti-PD-L1 drug Imfinzi (durvalumab) to treat patients with unresectable hepatocellular carcinoma (HCC). The commercial impact of the dual checkpoint therapy, however, remains to be seen, as it goes up against Roche Holding AG’s combination of Avastin (bevacizumab) and Tecentriq (atezolizumab), which gained standard-of-care status in first-line HCC in 2021.
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GSK looking to escape US fate of other HIF-PHI drugs for anemia in kidney disease patients

Oct. 24, 2022
By Mari Serebrov
Hoping its drug, daprodustat, can succeed in the U.S. where two other hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) have failed so far, GSK plc will present its case Oct. 26 to the FDA’s Cardiovascular and Renal Drugs Advisory Committee for the drug's potential use as a treatment for anemia in patients with chronic kidney disease regardless of dialysis dependency.
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Artificial intelligence and digital health icons
Drug Design, Drug Delivery & Technologies

AI model helps make preclinical drug design more accurate

Oct. 20, 2022
By Helen Albert
Researchers based at the City University of New York (CUNY) have designed a deep learning artificial intelligence (AI) model that can improve preclinical predictions of drug responses in humans. As outlined in the Oct. 17, 2022, online issue of Nature Machine Intelligence, the researchers believe their model – a context-aware deconfounding autoencoder (CODE-AE) – can help improve the quality of early drug response prediction and help reduce subsequent clinical trial failures.
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Toy bulldozer moving FDA letter blocks

FDA breakthrough device designation stimulates increased interest in Sinaptica

Oct. 19, 2022
By Annette Boyle
Sinaptica Therapeutics Inc. received a U.S. FDA breakthrough device designation for its electromagnetic therapy for Alzheimer’s disease. Sinaptistim-AD combines neurostimulation, brain wave monitoring and artificial intelligence (AI) to address the cognitive and functional decline in patients with the neurological disorder.
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Makena

More study needed, adcom says in voting for Makena withdrawal

Oct. 19, 2022
By Mari Serebrov
In a bit of déjà vu, the U.S. FDA’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee once again voted that Makena (hydroxyprogesterone caproate) should be withdrawn from the U.S. market while a second confirmatory trial is designed and conducted. But this time around, the committee’s 14-1 vote was much more decisive than its 9-7 vote in 2019.
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