Policy & Regulation

Former medical device CEO convicted for medical device fraud

March 8, 2024 - In a press announcement published on March 6, 2024, the United States Attorney’s Office of the Southern District of New York revealed that Laura Perryman, founder and former CEO of Stimwave, was convicted on one count of healthcare fraud and conspiracy to commit healthcare fraud. The charges carry a maximum sentence of 30 years; however,...

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CDC’s Updated COVID Isolation Guidelines: Realistic or Relaxed?

by Veronica Salib

On Friday, March 1, 2024, the United States Centers for Disease Control and Prevention (CDC) issued a press release revealing that it no longer recommends that individuals with COVID-19 isolate for...

Climate Change Exacerbates Poor Air Quality, Risking Human Health

by Veronica Salib

On Monday, February 12, 2024, First Street Foundation, a nonprofit focused on quantifying and relaying the risks of climate change globally, released a report outlining the impacts of climate change on...

FDA Updates Medical Device Sterility Guidelines

by Veronica Salib

Earlier this week, on January 8, 2024, the United States FDA announced a revised version of its guidance on medical device sterility: Submission and Review of Sterility Information in Premarket...

Reckitt Recalls Nutramigen Infant Formula for Bacterial Contamination

by Veronica Salib

Closing out the year, Reckitt, which owns Mead Johnson Nutrition (MJN), voluntarily recalled six batches of Nutramigen Powder, an infant formula sold under the Enfamil brand, on December 31, 2023. The...

Abortion Rights on the Line Again as SCOTUS Hears Mifepristone Case

by Veronica Salib

On December 13, 2023, the Supreme Court of the United States (SCOTUS) agreed to review an August case whose appeals court decision restricted access to mifepristone, one of the two drugs used for...

Texas Supreme Court Overturns Abortion Decision from Lower Court

by Veronica Salib

Yesterday, December 11, 2023, the Texas Supreme Court issued a ruling that overturned a lower court’s decision to grant Kate Cox an abortion. The lower court decision was issued last Thursday and...

November 2023 Elections Mark 3 Big Wins for Abortion Rights

by Veronica Salib

On November 7, 2023, three states, Ohio, Kentucky, and Virginia, voted in favor of maintaining abortion rights. Although policy changes were only on the ballot in Ohio, votes in Kentucky and Virginia...

FDA Launches Advisory Committee for Digital Health Technologies

by Veronica Salib

In a press release on October 11, 2023, the United States Food and Drug Administration announced that it created a new Digital Health Advisory Committee. According to the release, the committee will...

FDA Issues Three New Draft Guidance Documents for Medical Devices

by Veronica Salib

Last week, the United States Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) issued three new draft guidances to alter the 510(k) program. According to a statement...

Fifth Circuit Appeals Court Restricts Access to Abortion Pill

by Veronica Salib

On Wednesday, August 16, 2023, the United States Court of Appeals for the Fifth Circuit issued a decision that will restrict access to medication abortions. While the new ruling does not reverse the...

NY Governor Signs Legislation Protecting Abortion Care Providers

by Veronica Salib

On June 23, 2023, Kathy Hochul, the governor of New York, extended the previous protections for abortion care providers, guarding providers in NY when offering telehealth abortion services to patients...

USPSTF Updates Depression, Suicide, Anxiety Screening Recommendations

by Veronica Salib

Earlier this week, the United States Preventative Services Task Force (USPSTF) updated its screening recommendations for . The suggestions may guide mental health professionals, endorse early...

How Does Race Impact Recommendations for Breast Cancer Screening?

by Veronica Salib

An investigation published in JAMA Network Open explained how race and ethnicity might impact recommendations for breast cancer data. Based on the researchers’ analysis, they provided...

SCOTUS Votes to Uphold Mifepristone Approval, Maintaining Access

by Veronica Salib

On Friday, April 21, 2023, the Supreme Court of the United States (SCOTUS) issued a ruling upholding mifepristone approval, pending ongoing cases. The SCOTUS decision does not guarantee unlimited...

House of Representatives Votes to Declassify COVID-19 Origins

by Veronica Salib

In an astounding 419 to 0 vote on Friday, March 10, 2023, the United States House of Representatives unanimously favored declassifying information on the origins of COVID-19. While the two sides of the...

Globus Medical and NuVasive Agree to $3.1B Merger

by Hayden Schmidt

On Thursday of last week, Globus and NuVasive announced their decision to enter into a definitive agreement combining the two companies in an all-stock transaction. The deal was unanimously approved by...

Guidance for Reducing the Carbon Footprint of Inhaled Anesthesia

by Alivia Kaylor

Guidance published in Anesthesia, the official journal of the Association of Anaesthetists, offers actionable steps to mitigate the carbon footprint created from inhaled anesthetics comprising...

Planned Parenthood Closures Increased Severe Maternal Morbidity

by Veronica Salib

The recent political climate surrounding access to reproductive health and reproductive rights has left many, including patients, providers, and public health experts, anxious about the state of...

AMA House of Delegates Adopts New Reproductive Healthcare Policies

by Veronica Salib

As healthcare professionals, patients, and public health experts continue to navigate the reproductive healthcare space in a post-Dobbs world, many have run into challenges. The American Medical...

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