FDA Law

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. By Philip Won & Adrienne R.

Provider 75

Provider IT Engineering Medical 75

FDA Law

AUGUST 9, 2021

Farquhar — On the heels of Genus Medical Technologies’ successful lawsuit against FDA—Genus was represented by Hyman, Phelps & McNamara PC—in both the District Court of D.C. The Federal Register Notice specifically addresses medical imaging products, like those at issue in the Genus case. Koblitz & Douglas B.

IT 52

IT Medical Complication Provider 52

The Clinical Problem Solvers

APRIL 5, 2022

Do you have a medical respite center? Dr. Kushel and Mr. Watts remind healthcare providers to speak out about the structural causes of homelessness. Dr. Kushel detailed how the use of dehumanizing language equates to complicity in a narrative that systemically harms our neighbors with lived expertise in homelessness.

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Community Patient-Centered Emergency Room Medical 52

The Clinical Problem Solvers

FEBRUARY 8, 2023

Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group. This parallels another process, which is the medicalization of human experiences, especially those relating to childbirth and pregnancy.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

Physician's Weekly

JUNE 19, 2025

When Bob changed jobs, the price tag for his daughter’s medication went through the roof. In January of last year, Cole went to a Walgreens in Appleton, Wisconsin, to get refills on the medication he used to control his asthma. Bob’s journey here begins in 2019 — the first day of high school for his daughter, Mary.

Insurance 52

Insurance IT Board-Certified Medical 52

GeriPal

MARCH 9, 2023

In our prior podcast with Ira Byock on psychedelics in 2019 we talked primarily about the potential of psychedelics. Brian: For the use of substances like psilocybin and LSD in medical care, or at least in investigational treatments, I like to call it psychedelic therapy. Alex: It’s complicated. Where does ketamine fit in?

Patient-Centered 91

Patient-Centered Community IT Medical 91

GeriPal

AUGUST 25, 2022

I had looked at a research article that had recently evaluated the prevalence of private equity transactions in the hospice market and noted that there was a pretty substantial uptick in the past decade, and really over the course of say around 2015 to 2019. Basically, there’s a lot of variation amongst hospice providers.

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Family Families IT Patients 107