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BioWorld - Thursday, January 8, 2026
Home » Topics » Regulatory » NIH

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Regulatory front for March 11, 2021

March 11, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NIH touts new polygenic risk score methodology; HHS extends comment period for HIPAA NPRM.
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Product image

Pixcell Medical’s Hemoscreen going RURAL as part of research initiative

Feb. 24, 2021
By Annette Boyle
The National Institutes of Health selected Pixcell Medical Ltd.’s Hemoscreen hematology analyzer as part of the six-year Risk Underlying Rural Areas Longitudinal (RURAL) research study, aiming to gain insight into the specific health-related concerns of the rural southeastern United States' population. The RURAL study is funded by the National Heart, Lung and Blood Institute and aims to understand health concerns specific to rural communities in the South, particularly related to increased rates of heart, lung, blood and sleep disorders.
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Regulatory front for Feb. 24, 2021

Feb. 24, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: ACLA sees need for clarification of test coverage; MITA seeks transparency at USPSTF; NIH eyes license for cancer therapy; GAO says federal agencies falling short on recommendations; TGA updates guidance for risks in drugs and devices.
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DNA on digital background

NIH says phased genome assembly will enable preventive medicine

Feb. 10, 2021
By Mark McCarty
Preventive medicine hasn’t always had the backing of hard data, but research into genomics at the U.S. National Institutes of Health may soon change that.
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DNA on digital background

NIH says phased genome assembly will enable preventive medicine

Feb. 9, 2021
By Mark McCarty
Preventive medicine hasn’t always had the backing of hard data, but research into genomics at the U.S. National Institutes of Health may soon change that. Evan Eichler of the Howard Hughes Medical Institute said on a recent NIH webinar that phased genome assembly may allow medical science to efficiently treat diseases caused by genetic disorders, but will also enable preventive medicine, the holy grail of those who seek to restrain the ever-increasing cost of medical care.
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Opticyte plans trial of cellular oxygen monitor to detect sepsis

Jan. 15, 2021
By Mary Ellen Schneider
Opticyte Inc., a medical device startup, is planning the first clinical trial of its cellular oxygen monitor, a new device that could help emergency physicians diagnose sepsis faster and prevent organ failure. The prospective, observational trial is set to launch in mid-2021.
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Regulatory front for Jan. 14, 2021

Jan. 14, 2021
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS examines device classification process at FDA; NIH offers NGS system for SARS-CoV-2; FDA issues pandemic policy for coagulation systems.
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Regulatory front for Jan. 13, 2021

Jan. 13, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: New test beats biopsy for transplant rejection; NICE eyes digital health HTAs; MHRA moves on the hazards of bedrails; TGA zeroes in on tests for COVID-19; HHS posts rule for agency enforcement action.
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Regulatory front for Dec. 28, 2020

Dec. 28, 2020
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS unveils push toward digital collection of quality measures; NIH awards for ‘outside-the-box’ projects under RADx; ISO posts IP management standard.
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U.S. Capitol and $100 bills

Congress gives NIH, FDA slight funding bump for fiscal 2021

Dec. 22, 2020
By Mari Serebrov
After nearly three months of the U.S. federal government operating on stopgap spending measures, Congress has agreed to a $1.4 trillion spending bill for fiscal 2021. The omnibus package, which includes $97 billion for the Department of Health and Human Services, gives both the FDA and NIH small increases in funding.
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