article thumbnail

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog

However, FDA states that this exemption does not apply to corporate or hospital laboratories that employ licensed practitioners, and the agency says FD&C Act otherwise contains no exception or limitation for devices manufactured by laboratories. This comparison is misplaced.

article thumbnail

Long Time Passing: Where Have All the De Novo Decision Summaries Gone?

FDA Law Blog

Since 2010, FDA has posted classification orders and decision summaries for devices classified through the De Novo classification process. These summaries can be invaluable to companies that want to get their own clearance, providing the details that can be the key to understanding what the recipient of the De Novo did.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Transforming the Culture of Dementia Care: Podcast with Anne Basting, Ab Desai, Susan McFadden, and Judy Long

GeriPal

When was that, 2010? Eric: 2010. I think … There’s so few, seriously, from the hospital system and the pathologizing systems to the more social care intervention work that Susan and I really do. There’s a whole age-friendly hospital systems that we are supposed to start our journey and keep going.

Community 102
article thumbnail

Palliative care for cancer: Podcast with Jennifer Temel and Areej El-Jawahri

GeriPal

Alex: And we are also delighted to welcome Areej El-Jawahri, who is an oncologist at Massachusetts General Hospital as well, who specializes in blood cancers. Jennifer: It was 2010. Eric: 2010. Jennifer: They have a meaningful impact on what happens to them during the hospitalization and after. Jennifer: Thanks.

Illness 111
article thumbnail

Understanding the Variability in Care of Nursing Home Residents with Advanced Dementia

GeriPal

On today’s podcast we dive into drivers of invasive procedures and hospitalizations in advanced dementia by talking to some pretty brilliant nursing and nurse practitioner researchers focused on dementia, geriatrics, and palliative care in nursing homes: Ruth Palan Lopez, Caroline Stephens, Joan Carpenter, and Lauren Hunt. Rehabbed to Death.

article thumbnail

The importance of social connection: Julianne Holt-Lunstad, Thomas Cudjoe, & Carla Perissinotto

GeriPal

But it’s interesting because I started seeing, even though for instance I was working on this much earlier, but I published my large meta-analysis linking this to risk for premature mortality back in my first one in 2010. And so I was really thinking about why are some of my people that are hospitalized doing better than others?

IT 100
article thumbnail

Hospice in Prison Part 1: An interview with Michele DiTomas and Keith Knauf

GeriPal

So in 2010, there were about 150,000 incarcerated people in California. But when we look at people over the age of 55, 55 and older, we had about 11,000 in 2010, and now we have 18,000 people aged 55 and older. When they built a new prison hospital in Stockton, the dialysis went there.

Family 133