Sound Physicians

NOVEMBER 19, 2024

It is, by design, built into the ways we educate, train, and support our clinical leadership. The medical director provides support and leadership for the clinical team to deliver the highest level of patient care while managing program sustainability and growth. Enter the associate medical director.

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Hospital Telemedicine Clinic Management 52

Sound Physicians

OCTOBER 30, 2024

Osman Saleem, Medical Director for our hospital medicine practice at Mercy Hospital of Buffalo in Buffalo, New York, to go behind the stethoscope and learn more about how he came to Sound and his leadership journey:    When did you first consider a career in medicine? It was my job to work back to that program and gain that respect back.

Hospital 52

Hospital Telemedicine Healthcare Provider 52

PEMBlog

JUNE 7, 2023

NASEMSO: Clinical care and restraint of agitated or combative patients by emergency medical service practitioners. This podcast episode hosted by Brad Sobolewski ( @PEMTweets ) and co-authored by Dennis Ren ( @DennisRenMD ) is all about what prehospital providers should do to get these agitated children safely to the ED.

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Transportation Patient-Centered Management Finance 122

FDA Law Blog

FEBRUARY 28, 2022

address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical study.”. What would be the potential benefits if companies prospectively design medical device clinical studies with input from diverse patient advisors?

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Patients Clinic Medical Patient-Centered 52

FDA Law Blog

JANUARY 22, 2024

Communication in this area included on-line videos, webinars, summits, conferences, and international outreach. Clinical Trials. We’ve recently discussed FDA’s clinical trial oversight , and OC didn’t miss the chance to emphasize that it has a role in developing policy about how FDA-regulated research should be conducted.

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Supply Chain Clinic IT Provider 59

FDA Law Blog

FEBRUARY 27, 2023

Comments, including data from research and clinical practice, that provides evidence that an alternate maximum day supply (other than the proposed 30-day supply). We will release exciting details of our upcoming webinar addressing telemedicine soon. Proposed practitioner recordkeeping obligations. Stay tuned.

Telemedicine 59

Telemedicine Telecommunication Telehealth Medical 59

PEMBlog

JUNE 14, 2023

Characteristics, Clinical Care, and Disposition Barriers for Mental Health Patients Boarding in the Emergency Department. This podcast episode hosted by Brad Sobolewski ( @PEMTweets ) and co-authored by Dennis Ren ( @DennisRenMD ) is all about what we should consider when boarding children in the ED for mental health reasons. PMID: 32393605.

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Mental Health Management Patient-Centered Illness 98

FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It

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IT Medical Patient-Centered Provider 69

FDA Law Blog

JUNE 21, 2023

Cato — On June 1, CDRH announced that it is seeking public comment on questions regarding how CDRH can facilitate access to medical technologies designed for use outside of traditional clinical settings, particularly in the home. What medical technologies could be ideal to transition to use in non-clinical settings?

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Medical Patients Healthcare Electronics 45

FDA Law Blog

OCTOBER 10, 2023

Non-Clinical Recommendations The draft guidance highlights non-clinical review areas that are generally relevant across 510(k) Implants and offers recommendations for performance data to include in a 510(k) submission. We find that this information is noteworthy for manufacturers to consider.

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Manufacturing Engineering Clinic Patients 45

FDA Law Blog

SEPTEMBER 20, 2021

The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries. based upon the anticipated clinical benefit of earlier patient access to the product.”. Notable Dates and Timelines – Applications open, Q4 of FY 2023.

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Patient-Centered Manufacturing Clinic Provider 52

Physician's Practice

JUNE 20, 2025

Those who pave new roads and create new paths find the connections between what others have done and what works in their practices. Dr. Christian Chaussy, a urologist in Munich, Germany, noted pitting on the surface of an aircraft as it approached the sound barrier—a unique occurrence caused by the shock wave created in front of a drop of moisture.

Management 52

Management Patient-Centered Appointment Patients 52

Today's Hospitalist

JUNE 7, 2025

They presented a rapid clinical update Webinar in May 2025 hosted by the Society of Hospital Medicine. ” All anti-obesity medications, even the earlier generation of these drugs—which include orlistat, phentermine, phentermine/topiramate (Qsymia) and naltrexone/bupropion (Contrave)—cause clinically significant weight loss.

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Hospital Management Diabetes Patients 66

FDA Law Blog

FEBRUARY 5, 2025

Validation of an AI-enabled device should also include, when feasible and appropriate, an evaluation of its repeatability and reproducibility, which may include testing using phantom, simulated, contrived, or clinical data. FDA plans to host a webinar to discuss the Draft Guidance. User Interface Software Description Section VI.B

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Management Provider Specialization Clinic 95

GeriPal

JANUARY 26, 2023

Eric: So we’re going to be talking about the intersection between structural racism and ageism, but before we go into that topic, Ramona, I think you have a song request for Alex. Ramona: I do. It’s called A Change Is Gonna Come by Sam Cooke. Eric: And can you describe why you picked that song? Alex: Thank you. I love this song.

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IT Patient-Centered Healthcare Patients 92

GeriPal

NOVEMBER 17, 2022

And which journal again? Ken Covinsky: JAMA Network Open. Eric: JAMA Network Open. Kenny Lam: Yeah, yeah. JAMA Network Open. Eric: But before we do, we have a song request. Luckily, it’s not going to go to Ken Covinsky, because he would do a Chicago Cubs song. Alex: Kenny Lamb. Eric: Kenny, do you have a song request? Kenny Lam: Yeah.

Community 97

Community IT Mental Health Medical 97

GeriPal

SEPTEMBER 14, 2023

That’s focused on older adults who are too frail to get into clinic. In that clinical experience, we saw a lot of older adults who would develop acute illness, often exacerbations of their chronic conditions. We relied on our clinical experience as geriatricians, that home-based primary care experience. Thanks, Bruce.

Hospital 115

Hospital Patient-Centered Supply Chain IT 115

FDA Law Blog

FEBRUARY 20, 2025

On February 19, 2025, Judge Sean Jordan in the Eastern District of Texas heard oral arguments in American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathologys (AMP) [1] lawsuit against the Department of Health and Human Services. The materials from this webinar are still available on FDAs website ( here ).

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Patient-Centered Consulting Government Clinic 102