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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 Critical Care is at the forefront of bringing coordinated leadership and clinical excellence to hospital ICUs and the patients within them.

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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 ).

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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.,

Medical 45
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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.

IT 69
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Lead, follow or get out of the way

Physician's Practice

Topics Access and Reimbursement Billing & Collections Coding & Documentation Finance Law & Malpractice MedMal by Coverys Patient Engagement & Communications Staffing & Salary Technology Media Video & Interviews Podcasts Medical World News Pearls Surveys Best States to Practice Great American Physician Survey Staff Salary Survey (..)

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

FDA Law Blog

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.

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Agitation Podcast Series Episode 2: Non-pharmacologic management of agitated children

PEMBlog

Patient that are agitated should always be treated with dignity and respect. This entails utilizing the least invasive non-pharmacologic means of assisting them, before moving to physical or chemical restraints. Structured team approach to the agitated patient in the emergency department. Government. Emerg Med Clin North Am.