Regulatory: Page 51

FDA updates policy for nixing 510(k) submissions

By AuntMinnie.com staff writers

The U.S. Food and Drug Administration (FDA) has issued new guidelines on its policy for determining when it will refuse to accept submissions for new 510(k) applications for medical devices.

January 30, 2018

What radiologists should know about 2018 MIPS changes

By Rebecca Farrington

What's going on with the latest changes to the Merit-Based Incentive Payment System (MIPS)? Radiology practices face a host of new rules in 2018. Rebecca Farrington, chief revenue officer at Healthcare Administrative Partners, helps unpack the changes in this new article.

January 30, 2018

FDA OKs MedyMatch AI software as breakthrough device

By AuntMinnie.com staff writers

The U.S. Food and Drug Administration (FDA) has granted an expedited access pathway designation to MedyMatch's artificial intelligence (AI) software for detecting intracranial hemorrhage, paving the way for a priority regulatory review as part of the FDA's new Breakthrough Devices program.

January 28, 2018

CMS delay of decision support creates opportunities

By Erik L. Ridley

Last year's decision by the U.S. Centers for Medicare and Medicaid Services (CMS) to delay implementation of imaging clinical decision-support requirements until 2020 creates an opportunity to win over skeptical clinicians, according to a January 24 webinar from the Society for Imaging Informatics in Medicine.

January 24, 2018

VA, CMS team up to tackle healthcare fraud

By AuntMinnie.com staff writers

The U.S. Department of Veterans Affairs (VA) and the U.S. Centers for Medicare and Medicaid Services (CMS) are partnering on data analytics to identify and prevent fraud, waste, and abuse.

January 23, 2018

MITA hails device tax suspension

By AuntMinnie.com staff writers

The Medical Imaging and Technology Alliance (MITA) said it applauded Congress for voting to suspend the medical device excise tax for two years.

January 23, 2018

MedPAC votes to recommend elimination of MIPS

By AuntMinnie.com staff writers

At its January 11 meeting, the Medicare Payment Advisory Commission (MedPAC) voted to recommend that Congress eliminate the Merit-Based Incentive Payment System (MIPS) and institute a new voluntary value program that will reward quality within the current fee-for-service Medicare program.

January 22, 2018

Combinostics gets FDA clearance for quantification software

By AuntMinnie.com staff writers

Finnish software developer Combinostics has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its cNeuro cMRI quantification software.

January 15, 2018

USPSTF rejects adding new risk factors for heart disease

By AuntMinnie.com staff writers

Should new risk factors such as coronary artery calcium and ankle-brachial index be added to traditional risk factors for assessing which patients might be at risk of peripheral arterial disease and cardiovascular disease? Not so fast, according to the U.S. Preventive Services Task Force (USPSTF).

January 15, 2018

CMS to ease rules for MRI scans of implantable devices

By Brian Casey

Reimbursement could soon get a lot easier for MRI scans of patients with implantable cardiac devices. The U.S. Centers for Medicare and Medicaid Services (CMS) on January 11 proposed withdrawing its requirement that payments for these scans only be made when the scans are performed within a clinical study.

January 10, 2018

FDA hosts webinar on 3D printing guidance

By AuntMinnie.com staff writers

The U.S. Food and Drug Administration (FDA) held a webinar on January 10 reviewing its final guidance for creating medical products using 3D printers.

January 10, 2018

CMS introduces new bundled payment model

By AuntMinnie.com staff writers

The U.S. Centers for Medicare and Medicaid Services (CMS) has introduced a new voluntary bundled payment model called Bundled Payments for Care Improvement Advanced (BPCI Advanced), which will allow participants to earn additional payment if all expenditures for a beneficiary's episode of care are under a spending target that factors in quality.

January 9, 2018

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