Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies.

FDA announces full recall of Baxter Life2000 ventilators over cybersecurity flaw
All models and lot numbers of the units are subject to the recall. The security vulnerability could allow an unauthorized person to access and control the pumps, posing a serious health risk to patients.
Reimbursement for AI-based plaque assessments is improving
A growing number of private insurers are now covering these advanced technologies. Roosha Parikh, MD, told Cardiovascular Business that the hard work of SCCT and other groups has helped make this happen.
Medtronic recalls data management software, urging healthcare providers to run update
The error caused incorrect glucose data to be displayed to clinicians. According to Medtronic, any treatment decisions or recommendations based on those data need to be revisited.
Catheters recalled due to defect—FDA highlights risk of stroke or brain damage
The recall was put in place after a hydrophilic coating was discovered on the inside of the devices. According to the FDA, patients treated with the catheters could face a number of significant risks.
Radiology societies urge caution when implementing AI in pediatric imaging
Six professional organizations including the Society for Pediatric Radiology made their case in a joint statement published across multiple medical journals Nov. 25.

CT colonography the most cost-effective cancer screening option for many

Findings from the Neiman Health Policy Institute and Northwell Health indicate that CTC is especially beneficial for underserved populations.

FDA clears AI-powered ‘thermometer of the future’ with ECG sensors

BeamO combines electrocardiogram sensors, a stethoscope and a thermometer into a single device that patients can use at home to learn more about their health. Findings can then be submitted for a cardiologist to review.

Interventional radiologists who neglect E&M visits risk losing more lucrative procedures

“This study affirms that when interventional radiologists are afforded the time to evaluate and follow their patients, the complexity and value of the care they provide increases," one expert notes.

Less than 30% of FDA-authorized radiology AI devices have undergone clinical testing

A new research paper details the path to approval for nearly 1,000 AI/ML algorithms, highlighting significant gaps in testing.

Healthcare AI today: Artificial superintelligence, Heart Association AI leadership, human-centered healthcare AI, more

Never mind artificial general intelligence. Worry about artificial superintelligence.

The CUSA Clarity Ultrasonic Surgical Aspirator System from New Jersey-based Integra LifeSciences

FDA clears ultrasonic surgical aspiration tech for cardiac surgery

The technology, developed by New Jersey-based Integra LifeSciences, is already approved for several other specialties, including neurosurgery and orthopedic surgery.

bipartisan house task force on artificial intelligence

House Democrats push for last-ditch amendment to protect ACA subsidies for 3 years

With the U.S. Senate passing a funding agreement to reopen the federal government, the House of Representatives will now have a chance to make changes—though there’s little chance this particular amendment will succeed.

SCAI President Srihari S. Naidu, MD, professor of medicine at New York Medical College, explained some of the key payment issues interventional cardiologists are facing amid declining Medicare reimbursements.

SCAI fighting for interventional cardiologists amid challenging payment policies

SCAI President Srihari Naidu, MD, detailed some of the challenges interventional cardiologists face as reimbursements keep declining. The group has been building new partnerships with other medical societies to strengthen its influence in Washington.

Policy & Regulations

FDA announces full recall of Baxter Life2000 ventilators over cybersecurity flaw

Reimbursement for AI-based plaque assessments is improving

Medtronic recalls data management software, urging healthcare providers to run update

Catheters recalled due to defect—FDA highlights risk of stroke or brain damage

Radiology societies urge caution when implementing AI in pediatric imaging