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United States

Set Alert for Policy and Regulation United States

MTI Profile: US FDA's Second-In-Command Has Her Eye On A Tech-Forward Future

As principal deputy commissioner of the FDA, Amy Abernethy is focused on developing overarching policies that affect all its product centers. But perhaps what will stand as her legacy is her work to develop a data-centered strategy to improve how the agency reviews products and ensures their long-term safety and efficacy.

Leadership FDA Regulation
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Latest From United States, Policy & Regulation

Class I Recall On Edwards Sapien 3 Ultra Valve System

An ongoing recall of Edwards Lifesciences’ Sapien 3 Ultra transcatheter heart valve system has been elevated to Class I, indicating the US FDA’s highest risk level.

Recalls Cardiology

Pediatric Scoliosis Device Nabs HDE Approval

The US FDA has approved Zimmer Biomet’s Tether device, which is the first device of its type cleared to treat children with a form of spinal curvature. It's also the first pediatric spinal device to net Humanitarian Device Exemption approval from the agency in 15 years, the company says.

Orthopedics Approvals

Ambu Settles US Defense Department False-Claims Allegations

Danish device-maker Ambu has agreed to pay $3.3m to resolve allegations of False Claims Act violations. The company is said to have made medical product in Malaysia and China for sale to the Departments of Defense and Veterans Affairs, which is forbidden under the Trade Agreements Act.

Enforcement Policy

No Pay Incentives Needed For Non-Opioid Pain Control Devices, CMS Says; Industry Disagrees

Medtech firms couldn’t convince the US Medicare agency to propose additional temporary payments under Medicare for non-opioid pain management device alternatives in its proposed rule for outpatient hospitals and ambulatory surgical centers. In response, industry advocacy group AdvaMed plans to gather more data in support of payment incentives before a mid-September deadline comes for comments on the rule.

Reimbursement Medicare

Top FDAer Skeptical Of Wearable Devices, Says Agency Is Working To Improve Standards And Technology

Amy Abernethy, the principal deputy commissioner at the US FDA, told attendees at a 25 July medical conference that she's somewhat skeptical about using wearable technologies for clinical needs because they still haven’t proven their accuracy. However, she says the device center is working hard to develop new standards for such products and is looking for funding to develop them.

Regulation Digital Health

T2Bacteria Panel Wins CMS Approval For New Tech Add-On Payment

The US Medicare agency approved a new technology add-on payment (NTAP) for T2 Biosystems’ blood test, the T2Bacteria panel, for the fiscal year that will begin on 1 October.

Reimbursement Medicare
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