Vascular Physician

MARCH 25, 2022

Treatment Options Conservative management includes lifestyle changes such as smoking cessation, weight loss, and regular physical exercise. CT angiography can be used to determine the underlying cause and develop a treatment plan. Medications to use include controlling dyslipidemia, hypertension, and diabetes along with antiplatelet therapy.

Hypertension 52

Hypertension Treatment Plan Diabetes Diagnosis 52

Vascular Physician

FEBRUARY 23, 2020

· On physical exam, findings that would indicate PAD include wounds located on the tips of the toes or foot, wounds covered by black eschar or gangrenous changes, shiny atrophic skin, lack of pedal hair or weak or absent pedal pulses. · A critical analysis of current treatment unmasks the clinical and economic costs of CLI.

Referral 40

Referral Diabetes Management Physicals 40

FDA Law Blog

JULY 10, 2024

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

Patients 59

Patients Patient-Centered Clinic Medical 59

FDA Law Blog

JANUARY 12, 2025

As such, we will publish a separate blog post focused on confirmatory trials and how FDA is interpreting this key provision of its accelerated approval authority. an intermediate clinical endpoint) and that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.

Clinic 64

Clinic Relationship Provider IT 64

The Motivated MD

OCTOBER 10, 2024

So, with this chapter, I hope to briefly touch on the basics of market investing and describe why simple diversification and index fund investing are the most effective ways for busy clinical physicians and healthcare providers to invest with the expectation of long-term gains. Most clinical physicians are busy.

Finance 52

Finance Individual Management IT 52

FDA Law Blog

OCTOBER 28, 2024

To this end, FDA recently announced the publication of a guidance titled “Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development,” (the “Guidance”). When a comprehensive neurodevelopmental evaluation is needed, it should include an evaluation of physical, mental, and social health.

Clinic 64

Clinic Physicals IT Referral 64

FDA Law Blog

JANUARY 4, 2023

The next town hall will focus on the clinical development of gene therapy products for rare diseases in February 2023. There was a lot of information on CMC regulatory requirements and pitfalls for cellular therapies and tissue engineered products discussed during the OTAT town hall that are not included in this blog. Comparability.

Manufacturing 59

Manufacturing Engineering Clinic Provider 59

FDA Law Blog

JANUARY 19, 2022

There are numerous examples where device output is controlled to maintain a physical measurement, such as pressure, at a set point. We were interested to see that clinical testing does not appear to be a major focus for these devices, though it is mentioned as a possible means of validation.

Patients 52

Patients Medical Clinic Provider 52

FDA Law Blog

JANUARY 19, 2022

There are numerous examples where device output is controlled to maintain a physical measurement, such as pressure, at a set point. We were interested to see that clinical testing does not appear to be a major focus for these devices, though it is mentioned as a possible means of validation.

Patients 52

Patients Medical Clinic Provider 52

FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers. FDA’s position is, however, only one side of the story.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

PEMBlog

AUGUST 30, 2023

This is a blog post and a podcast episode designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not.

Asthma 52

Asthma Electronics Utilities Clinical Practice 52

FDA Law Blog

DECEMBER 12, 2023

In fact, clinical studies estimate that as many as 23% of cats suffer from urolithiasis. RSS is a measurement used to estimate the potential for crystal formation and bladder stone (urolith) growth, a common affliction in cats.

Utilities 59

Utilities Manufacturing Provider Individual 59

GeriPal

MARCH 14, 2024

Eric: Well, before we talk about dysphagia and revisit it, which is also interesting, because this is our first podcast, I think on dysphagia, but we’ve talked about it before on GeriPal, in our blog. I think someone has a song request for Alex. Raele: I do. I have one. Change by Blind Melon. Eric: Why did you choose this? Eric: Fancy.

IT 125

IT Hospital Patient-Centered Individual 125

PEMBlog

SEPTEMBER 6, 2023

This is a blog post designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not. Health Aff (Millwood).

Lab Testing 52

Lab Testing Medical Patients Mental Health 52

FDA Law Blog

AUGUST 18, 2024

Each of these De Novos can represent a clinical advance. De Novos now play an important role in product advancement. For example, FDA granted seven De Novos for COVID-19 related indications for use. Equally important, once these De Novos are authorized, they can serve as predicate devices in the 510(k) process.

Specialization 69

Specialization Hospital Physicals Provider 69

FDA Law Blog

FEBRUARY 29, 2024

A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. Drug companies are still required to conduct studies to confirm the anticipated clinical benefit.

Clinic 59

Clinic IT Provider Patient-Centered 59

FDA Law Blog

JANUARY 2, 2022

The National Institute of Biomedical Imaging and Bioengineering describes computational modeling as “the use of computers to simulate and study complex systems using mathematics, physics and computer science.” As FDA indicates, it is especially important to consider these issues within the clinical context (conditions of use).

Medical 52

Medical Provider Physicals Engineering 52

FDA Law Blog

JULY 5, 2023

FDA clarifies that the “sold or transferred” statutory language makes it clear that the prohibition applies to the physical movement of the product, regardless of whether or not money has changed hands. Draft Guidance III.B.2(e) Draft Guidance III.B.2(d) More specifically, the prohibition includes when a “third party (e.g.,

Supply Chain 52

Supply Chain Manufacturing Physicals Healthcare 52

PEMBlog

SEPTEMBER 13, 2023

This is a blog post designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not.

Patients 52

Patients Screening Illness Physicals 52

PEMBlog

OCTOBER 2, 2024

I’ll dive into the latest clinical practice guidelines and discuss evidence-based approaches to diagnosis and treatment. Understanding dyspepsia and its clinical presentation. Now, in the pediatric emergency department, the diagnosis of reflux is primarily clinical.

Diagnosis 52

Diagnosis Management Patient-Centered IT 52

Pamela Wible MD

JUNE 20, 2025

(Published 3/18/19, updated 6/20/25) What Is Physician “Burnout”—and Why It Matters Physician “burnout” is a state of emotional, physical, and mental exhaustion caused by prolonged stress in the medical workplace. So why are physicians experiencing physical and mental collapse from overwork?

Medical Student 246

Medical Student Diagnosis Physicals Medical 246

FDA Law Blog

JANUARY 2, 2022

The National Institute of Biomedical Imaging and Bioengineering describes computational modeling as “the use of computers to simulate and study complex systems using mathematics, physics and computer science.” As FDA indicates, it is especially important to consider these issues within the clinical context (conditions of use).

Medical 40

Medical Provider Physicals Engineering 40

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). Proposed practitioner recordkeeping obligations. Additional safeguards or flexibilities that should be considered with respect to the rule.

Telemedicine 59

Telemedicine Telecommunication Telehealth Medical 59

Rao Doctor

APRIL 3, 2025

Infrared thermometers, which measure temperature from the forehead or ear, are also prevalent in clinical settings. Importance of Physical Examinations Physical examinations also play a significant role in diagnosing health conditions. Digital thermometers are commonly used due to their accuracy and ease of use.

Diagnosis 130

Diagnosis Management Illness Diagnose 130

Mesa Family Physician

JUNE 11, 2025

In this blog, we’ll break down what preventive care involves, explore its relationship with short-term health insurance, and explain why it’s a critical part of staying healthy at any stage of life. Preventive” is more commonly used in clinical and formal writing, while “preventative” is more casual. Are they the same?

Illness 100

Illness Preventive Care Preventative Care Insurance 100

FDA Law Blog

JULY 7, 2024

The guidance restates the central premise of the final rule, i.e., that LDTs are medical devices and the clinical laboratories that design, manufacture and use them to test patient specimens are manufacturers. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R. 820.198). .

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

Vascular Physician

MARCH 29, 2022

While not as common as aortic artery aneurysms (AAA), the risk of mortality from PAAs necessitate a familiarity with the correlating clinical signs and symptoms. On physical examination, the affected region may be swollen and erythematous though non-tender.

Complication 52

Complication Screening Hypertension Patients 52

GeriPal

FEBRUARY 29, 2024

But when we have people in rural areas of California, so we don’t know our clinical site, we go from San Francisco all the way to the Northern California border, super rural areas. I actually wrote a blog post about this when we were a blog. We were a blog? But I remember having a conversation with them.

IT 127

IT Patient-Centered Illness Education 127

GeriPal

DECEMBER 8, 2022

Eric’s blog post on Dignity Therapy from 2011. And then we also have another Vas, many of the interviews are done by medical students or other healthcare trainees as part of their clinical rotation at the VA. Working with our clinical decision support team and thinking about where that could be. About us – Dignity in Care.

Patient-Centered 116

Patient-Centered Illness Healthcare IT 116

Noreta Family Medicine

APRIL 17, 2024

Other family doctors only see patients in their clinics. I enjoy seeing patients for all kinds of visits as well – mental health, physicals, GYN concerns, coughs/colds, etc. Some family doctors work in a residency training program where they may see patients in the hospital, out of the hospital, and deliver babies.

Primary Care 52

Primary Care Board-Certified GP DO 52

FDA Law Blog

JANUARY 18, 2024

Controlled substances that have an accepted medical use are classified in schedules II-V based on their relative potential for abuse and physical and psychological dependence. or a currently accepted medical use with severe restrictions; and The drug’s relative safety or ability to produce physical dependence compared to other drugs.

Medical 69

Medical Physicals IT Healthcare Professional 69

FDA Law Blog

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). intended use population.

Clinic 59

Clinic Provider Individual IT 59

FDA Law Blog

OCTOBER 16, 2024

Left ventricular ejection fraction (LVEF) is a variable measure, so use clinical judgment in deciding whom to treat.” Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal.

Manufacturing 98

Manufacturing Patients IT Hospital 98

GeriPal

DECEMBER 15, 2022

And then we also have another Vas, many of the interviews are done by medical students or other healthcare trainees as part of their clinical rotation at the VA. Working with our clinical decision support team and thinking about where that could be. She’s a clinical research coordinator trained for many years.

IT 106

IT Patient-Centered Healthcare Illness 106

FDA Law Blog

JANUARY 1, 2024

Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators. Finally, FDA said in a Warning Letter that a Clinical Investigator, Anish S. If FDA wanted to create that impression, it likely succeeded. Shah, M.D.,

Manufacturing 59

Manufacturing Clinic Medical IT 59

GeriPal

SEPTEMBER 22, 2022

And I think also some of the stuff we’ll be talking about, when it comes to communication, I mean, a lot of the clinical encounter is listening to the music. Tell me about the clinical enc… How do you think the uncanny valley fits into medicine and communication training and skills? What is the uncanny valley? Eric: Yeah.

Illness 102

Illness IT Patient-Centered Patients 102

FDA Law Blog

MAY 5, 2024

and their abuse may lead to moderate or low physical dependence or high psychological dependence. FDA further noted that clinical studies demonstrate that marijuana produces physical and psychological dependence, and abuse may lead to moderate or low physical dependence depending on frequency and degree of marijuana exposure.

Medical 95

Medical Manufacturing Physicals Healthcare Professional 95