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BioWorld - Sunday, December 21, 2025
Home » Topics » U.S., BioWorld MedTech

U.S., BioWorld MedTech
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Regulatory front for March 10, 2021

March 10, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Stimulus passes, no Medicare sequestration relief; OIG cites improper claims for polysomnography; Four senators seek feedback on Section 101 hangup.
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Lock on digital globe illustration

Second California privacy law sets up dual enforcement entities

March 9, 2021
By Mark McCarty
In a span of a mere two years, the state of California passed two ballot initiatives dealing with privacy that promise to have an impact on digital health, the second of which created an office specifically for privacy enforcement matters. Eric Goldman, a professor of law at the Santa Clara (California) University School of Law, said on a recent webinar that the state attorney general’s office and the new California Privacy Protection Agency (CPPA) have overlapping jurisdiction, and as a consequence, companies doing business in California may find themselves at the mercy of not one, but two enforcement entities.
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Ultrasound set-up used in obesity and inflammation study

Liver-focused ultrasound stimulation could reduce obesity and inflammation

March 9, 2021
By Annette Boyle
Stimulating the liver with focused ultrasound decreased obesity, chronic inflammation and metabolic dysfunction in preclinical studies, reported GE Research and the Feinstein Institutes for Medical Research, the research arm of Northwell Health. In a study published in Scientific Reports, researchers demonstrated that nerve modulation with ultrasound in mice helped regulate neurons involved in food intake, glucose regulation and metabolism without negative side effects.
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U.S. flag, stethoscope

MCIT program not seen as being at risk under Becerra at HHS

March 8, 2021
By Mark McCarty
The Biden administration imposed a regulatory freeze in January, which among other things affected the final rule for the Medicare Coverage of Innovative Technologies (MCIT) program. Despite the freeze, Cybil Roehrenbeck, a partner in the D.C. office of Hogan Lovells US LLP, told BioWorld that this program enjoys broad support in Washington, and thus should survive the new administration’s review of the program under Xavier Becerra, should he be appointed the Secretary of Health and Human Services.
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Medicare puzzle

$1.9T stimulus package could trigger 4% Medicare sequester

March 8, 2021
By Mari Serebrov
The voluminous American Rescue Plan – the second largest stimulus package in U.S. history – has something for everyone. Almost. The $1.9 trillion package that passed the Senate over the weekend and is expected to be passed by the House March 9 failed to extend the current moratorium, set to expire April 1, on the 2% Medicare sequestration.
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Telehealth illustration

Telehealth takeaway: Don’t forget about the patient

March 4, 2021
By Mark McCarty
A bad patient experience with telehealth can blunt adoption regardless of the incentives for developers and doctors. Griffin Mulcahey, chief compliance officer at Wheel Health Inc., of Austin, Texas, said during a recent webinar that users of these digital health apps and telemedicine programs may need assistance to get up to speed on an application, a critical effort that may make the difference between success and failure in telehealth.
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US flag, Department of Health and Human Services flags

U.S. Senate committee renders tie vote on Becerra to run HHS

March 3, 2021
By Mark McCarty
The U.S. Senate Finance Committee hearing for the appointment of Xavier Becerra as Secretary of Health and Human Services ended in a tie vote, which not unexpectedly ran along party lines. The nomination of Becerra was controversial on several fronts, but the outcome nonetheless sends the nomination to the Senate floor, where Vice President Kamala Harris may cast the deciding vote in what is likely to be a literal 50-50 deadlock.
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U.S. Capitol building

Skepticism of telehealth cost, utilization in the U.S. aired in hearing

March 2, 2021
By Mark McCarty
Several telehealth bills are in circulation on Capitol Hill, but U.S. federal government agencies have expressed concerns about the potential for fraud and abuse, and the impact on Medicare spending. Despite those concerns, two key members of the House Energy and Commerce (E&C) Committee, Reps. Frank Pallone (D-N.J.) and Anna Eshoo (D-Calif.), said during a March 2 hearing that they have misgivings about those cautionary views of telehealth, suggesting that any related legislation will aggressively expand Medicare coverage of telehealth.
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Software screenshot

Fifth Eye launches ML-based tool to predict hemodynamic instability

March 2, 2021
By Meg Bryant
The FDA has granted de novo authorization to Fifth Eye Inc. for its Analytic for Hemodynamic Instability (AHI), a machine learning (ML)-based, real-time indicator of patient deterioration. Commercialization of the software device, which continuously monitors patients with an electrocardiogram (ECG) for signs of deterioration, got underway on March 1.
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Product image

Rebus’ spatial omics platform minimizes hands-on time

March 1, 2021
By Annette Boyle
Rebus Biosystems Inc. introduced the first commercially available spatial omics platform at the Advances in Genome Biology and Technology virtual meeting on March 1. The Rebus Esper builds on the company’s Synthetic Aperture Optics (SAO) technology that enables rapid quantitative analysis of tens of millions of cellular features across hundreds of thousands of cells in their native tissue contexts.
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