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 Recall

FDA announces recall of SonarMed airway monitors after injury

Medtronic brand SonarMed airway monitors and acoustic sensors are being recalled due to a risk of breathing obstruction and lung tissue damage.

April 29, 2024
doctor's open hand waiting for a payment

‘Concerning’ data connect industry payments to cardiologists with medical device use

U.S. physicians often receive payments from medical device manufacturers and pharmaceutical companies. New research in JAMA found a connection between receiving such payments and using specific devices—should the industry be concerned? 

April 29, 2024
Take Care of Maya johns hopkins attorneys seek retrial

Reads completed on 'less sophisticated' monitors have radiology group refuting claims of billing fraud in court

The suit claims the group wrongfully billed CMS for over $6 million in image reads that did not qualify for Medicare reimbursement due to the subpar computer monitors used to view the studies.

April 29, 2024
Former managers of a Tampa Florida-based radiology company Advanced Diagnostic Group (ADG) and its employee stock ownership plan (ESOP) retirement benefit manager GreatBanc Trust Co. will pay $19 million to settle a class action lawsuit. The suit alleges they allowed the ESOP’s value to be diverted to managers, directors and their shell companies and away from employee participants. money gavel court lawsuit legal judge judgement

Philips settles cases over faulty sleep apnea machines for $1.1B

The litigation stems from a 2023 recall of CPAP machines and ventilators that caused users to inhale pieces of foam during use. The faulty units were linked to at least 561 deaths.

April 29, 2024
Money handcuffs price cost cap

State caps annual healthcare price increases despite opposition from radiologists

Connecticut, Delaware, Massachusetts, Nevada, New Jersey, Oregon, Rhode Island and Washington have already established such healthcare cost growth targets. 

April 29, 2024
Sectra receives FDA approval for use of DICOM in digital pathology

Sectra receives FDA's first clearance for use of DICOM pathology images

The clearance covers the use of Sectra’s digital review application in conjunction with Leica’s Aperio GT 450 DX scanner.

April 29, 2024
Abbott's Espirit BTK Everolimus Eluting Resorbable Scaffold gained U.S. FDA approval in April 2024. It is based on the former Abbott Absorb coronary stent, but indicated for use in peripheral artery lesions below the knee (BTK).

FDA approves Abbott’s resorbable stent for BTK arteries

The bioresorbable stent, examined at length for the LIFE-BTK clinical trial, stays in place for up to three years before completely dissolving. 

April 29, 2024
cyberattack cybersecurity IT

Disruptions to small practices’ operations remain ‘severe and ongoing’ months after Change cyberattack

Owner UnitedHealth had claimed services would be largely restored by late March, but doc groups such as the MGMA claim things are still a mess. 

April 26, 2024