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New FDA draft guidance seen as vital for digital companies new to regulation

Nov. 12, 2021

The FDA’s device center has revisited the 2005 guidance for the content of premarket submissions for device software functions, a document that puts much more emphasis on risk compared to the legacy 2005 guidance.

Medical technology Regulatory Digital health SAMD U.S. FDA

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Illustration of SCAN in Parkinson’s vs healthy subcortex

SCAN is core circuit affected in Parkinson’s disease

BioWorld

Parkinson’s disease is a neurodegenerative disorder that affects movement, and tremor is one of its signatures. But it is a much more wide-ranging disorder, and...

3D rendering of skin cells and elastin with collagen layer

First-in-class pan-inflammasome blocker for hidradenitis suppurativa

BioWorld Science

Researchers from Paratus Sciences Corp. presented the preclinical profile of PS-1001, a novel pan-inflammasome inhibitor designed to prevent IL-1β and IL-18 release.

Illustration of cancer cell in crosshairs being destroyed

RX-10616 improves radiotherapy efficacy in HNSCC

BioWorld Science

Head and neck squamous cell carcinoma (HNSCC) accounts for high number of new diagnoses each year. Current management is based on surgery followed by radiotherapy...

CROI 2026: Neurodegeneration, the challenge of aging with HIV

BioWorld

Antiretroviral therapies against HIV have been in use for more than 30 years and have enabled people living with HIV to maintain undetectable viral levels. Many...