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Portable Assay Offers Rapid, Low-Cost TB Diagnoses

Physician's Weekly

Researchers have engineered a portable “lab‑in‑tube” (LIT) assay that detects Mycobacterium tuberculosis (Mtb) DNA directly from blood, saliva, or sputum in less than 60 minutes at a relatively low cost, according to a study published in Science Translational Medicine.

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FDA Releases Final Guidance on Use of Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

FDA Law

Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. The guidance addresses the use of DHTs in clinical investigations of drugs, biologics, and medical devices.

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2025 Physician Wellness Retreats | Physician “Burnout” Retreats

Pamela Wible MD

Whether you’re launching your dream clinic, writing your first book, or exploring shamanic healing or magic mushrooms, these retreats are handcrafted to help you heal, grow, and thrive. Group retreats host 4 to 7 physicians, combining facilitated individual coaching and inspiring group activities.

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OTAT Becomes the Office of Therapeutic Products (OTP) and Kicks off Town Hall Series – They appear to be tired of writing the same “Complete Response” Letters

FDA Law

The standard practice is for FDA to engage with companies on an individual basis through formal meetings and deliver directed feedback to specific sponsor questions. OTP has spent years communicating industry-wide problems on an individual basis. OTP recognized that this strategy may not be possible for all products (e.g.,

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Hearing Loss in Geriatrics and Palliative Care: A Podcast with Nick Reed and Meg Wallhagen

GeriPal

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? We talk with Nick and Meg about: Why hearing loss is important not just in geriatrics but also for those caring for seriously ill individuals. I’m guessing not. How to screen for hearing loss. Transcript.

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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law

Collaborative Planning and Execution In the AI letter, deficiencies are arranged according to review areas, such as administrative information, 510(k) summary, performance data, engineering performance, biocompatibility, sterilization, software validation, clinical data, and labeling.

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Podcast: AI, innovation, and value-based care in medicine

Permanente Medicine

When I started over 20 years ago, saw babies being born, used to do circumcisions in clinics, and then taking care of patients as they got more mature in their life, so to speak, and really loved that. Patients nowadays have evolved, so our ability to build and engineer AI systems to help people help themselves is going to be the future.