Sound Physicians

MARCH 12, 2025

With larger metropolitan hospitals struggling to manage the limited capacity of ICU beds, timely patient transfer isn’t always an available option, and even when it is an option, patients and their families in the community have an expectation that they can stay local for care. Our answer: tele-critical care.

Telemedicine 52

Telemedicine Community Hospital Patients 52

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. and remote or wearable patient monitoring devices (e.g., telemedicine and telehealth solutions (e.g.,

Medical 45

Medical Patients Healthcare Electronics 45

FDA Law Blog

OCTOBER 10, 2023

Performance data should be customized to the indications for use, including the specific intended patient population (adult vs. pediatric), disease state, conditions of use, and the target anatomical location. In cases where devices are expected to be frequently replaced, testing should be guided by the aggregate patient exposure.

Manufacturing 45

Manufacturing Engineering Clinic Patients 45

FDA Law Blog

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

Today's Hospitalist

JUNE 7, 2025

Medical societies and hospitals are weighing in on periprocedural concerns in patients taking GLP-1s who need procedures or surgeries. That’s according to two internists who work closely with hospitalized patients who take GLP-1s. These medications are truly life-changing for many patients.”

Hospital 66

Hospital Management Diabetes Patients 66

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 ).

Patient-Centered 102

Patient-Centered Consulting Government Clinic 102