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. 

RSS icon
Artivion, an Atlanta-based medical device company, has received a Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA) for its AMDS Hybrid Prosthesis designed to treat DeBakey Type 1 dissections when malperfusion occurs. This HDE ensures select patients can be treated with the device before the FDA makes its final approval decision.

First surgical device of its kind granted key FDA exemption

This update helps ensure Artivion's AMDS Hybrid Prosthesis can be used to treat high-risk patients as the FDA makes its final approval decision. The news came as Artivion works to bounce back from a cybersecurity attack that occurred in November.

artificial intelligence AI in healthcare

Providers, payers share actionable experiences involving healthcare AI

A large venture capital firm focused on supporting early-stage healthtech companies has a tip for AI startups targeting the healthcare sector.

Anthem

Anthem BCBS reverses course on anesthesia time limits

After announcing it would place time limits on reimbursement for the time a patient is under anesthesia, Anthem Blue Cross Blue Shield has now denied it ever intended to make the change. 

FDA issues Class I recall on insulin syringes due to risk of death

A line of syringes manufactured by Cardinal Health may fail to properly inject insulin when used with needleless IV connectors. 

Stock image of an illegal bribe.

Operations manager, doctors charged in $70M imaging kickback scheme

The scam took place over a period of seven years, resulting in Medicare being billed for more than $70 million in fraudulent claims for unnecessary scans. 

artificial intelligence AI in healthcare

Healthcare-specific AI: How to multiply successes and head off accidents

Given the rapid proliferation of AI-equipped medical devices across U.S. healthcare, unintended effects should surprise no one. 

Thumbnail

Private-equity watchdog warns against nominating Marc Rowan as Treasury Secretary

The Private Equity Stakeholder Project likens Rowan to a fox guarding the hen-house, due to his position as CEO of Apollo Global Management. Rowan is being considered for a cabinet role in the incoming Trump administration. 

the words "FDA recall" on a board

FDA issues Class I recall on insertion tubes after manufacturing error

Specific FHC-branded insertion tubes used in brain surgery are 20mm longer than expected and could pose a serious risk to patients. 

Displaying 33 - 40 of 3420

Around the web

Cardiovascular Business
Why electrophysiologists needed a champion in Washington

Heart Rhythm Society President Kenneth A. Ellenbogen, MD, detailed a new advocacy group focused on improving EP reimbursements, patient care and access. “If you’re not at the table, you’re on the menu," he said.

Cardiovascular Business
Reimbursement update: What hospitals need to know about new Medicare payments for cardiac CT

CMS finalized a significant policy change when it increased the Medicare payments hospitals receive for performing CCTA exams. What, exactly, does the update mean for cardiologists, billing specialists and other hospital employees?

Cardiovascular Business
Stryker acquires Inari Medical for $4.9B

Stryker, a global medtech company based out of Michigan, has kicked off 2025 with a bit of excitement. The company says Inari’s peripheral vascular portfolio is highly complementary to its own neurovascular portfolio.