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Dedicated ICU management: Navigating the transition

Sound Physicians

For hospitals, this means investing in cutting-edge medical interventions and partnerships that help them transition to the modern best-practice of dedicated ICU management. Sound also supports residency programs, which guarantee a consistent pool of new critical care clinicians who can provide support in the ICU.

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Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

FDA Law Blog

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ). The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies.

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CDRH Seeks Public Comment on How to Increase Patient Access to At-Home Use Medical Technologies

FDA Law Blog

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. At-home medical technologies include, but are not limited to, monitoring and wearable devices (e.g.,

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A Final LDT Rule in April!? Will FDA be prepared?

FDA Law Blog

6] It is inconsistent to say that LDTs must be regulated as medical devices because of the newness of the tests and then reduce the cost of the proposed regulation by declaring that half of all LDTs will be exempt from premarket review. That seems very unlikely to be the case, because exemptions apply only to well-established tests.

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Lead, follow or get out of the way

Physician's Practice

Reynolds Blog Article Innovative medical practices thrive by embracing change, prioritizing patient care and learning from setbacks to enhance success and satisfaction. For example, practices have adopted electronic medical records (EMR) systems only to find that productivity in the practice ground to a halt.

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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

Below we provide an overview of some of the goals letter’s most notable contents such as new initiatives as well as some large-scale enhancements to programs that have already been in the works. STAR aims to facilitate earlier access to novel uses of existing therapies for patients with a serious condition with unmet medical needs.

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New South Family Medicine and MedSpa Offers Next Level Care

New South Family Medicine and MedSpa

Direct primary care offers you and your family top-notch health care, and so much more.like a high patient and provider satisfaction with an improved quality of care. Providers at New South Family Medicine and MedSpa can address the patient's deeper needs, rather than trying to rush through a hectic day full of too-brief appointments.

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