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ICU telemedicine programs bring essential critical care to community hospitals

Sound Physicians

Increasingly a valuable option for rural hospitals, tele-ICU provides access to higher acuity care and support to emergency and hospital medicine clinicians who are called to the ICU. Posted in Critical Care Share Article Subscribe to the Sound Physicians Blog A trusted source for todays healthcare needs. All rights reserved.

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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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FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

FDA Law Blog

In the case of 510(k) Implants indicated for use in pediatric patients, FDA recommends consulting two other guidance documents: Pediatrics Guidance and Extrapolation Guidance. If a submitter believes that certain testing described in the draft guidance does not apply to their device, they should provide a rationale in the 510(k) submission.

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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. Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments.

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Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument

FDA Law Blog

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 ).