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This inaugural webinar was a collaborative effort between FDA and NIH’s Small Business Innovation Research (SBIR) Development Center within the National Cancer Institute (NCI). Its purpose was to educate early-stage companies (small businesses) new to the regulatory landscape at the FDA. The genesis of this webinar can be attributed to the work that FDA, specifically SBIA, has contributed to NIH | SBIR in the past few years, and more recently with its Connecting Awardees with Regulatory Experts (CARE) Program.

Timestamps

01:26 – How Can DICE Help You?

19:47 – Medical Device Development Tools Program

32:44 – Medical Device Coverage Initiatives: Connecting with Payors via the Payor Communication Task Force

42:30 – Session III Q&A Panel

Speakers | Panelists:

Giselle Blanco
Consumer Safety Officer
Premarket Programs Branch (PPB)
Division of Industry and Consumer Education (DICE)
Office of Communication and Education (OCE) | CDRH

Jessica Mavadia-Shukla, PhD
Director | Medical Device Development Tools Program
Division of Partnerships and Innovation (DPI)
Office of Equity and Innovative Development (OEID)
Office of Strategic Partnerships and Technology Innovation (OST) | CDRH

Danielle Fau, MSE
Senior Advisor for Technology and Innovation
Division of Health Equity (DHE) OEID | OST | CDRH

Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/fda-nih-regulatory-dos-and-donts-tips-fda-09042024

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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

Upcoming Training - https://www.fda.gov/cdersbia
SBIA Listserv – https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2024 Playlist – https://www.youtube.com/playlist?list=PLey4Qe-Uxcxaf1HvpvnKO8-n8u9QW412g
SBIA LinkedIn - https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources - https://www.fda.gov/cdersbialearn
Twitter - https://twitter.com/FDA_Drug_Info
Email - [email protected]
Phone - (301) 796-6707 I (866) 405-5367

Read the full article at: www.youtube.com

A newly published study from Sweden unveiled a blood test capable of detecting Alzheimer’s disease with 90% accuracy.

Read the full article at: www.forbes.com

In a significant advancement for point-of-care medical diagnostics, a team of researchers from UCLA has introduced a deep learning-enhanced, paper-based vertical flow assay (VFA) capable of detecting cardiac troponin I (cTnI) with high sensitivity.

Read the full article at: phys.org

GE HealthCare’s MIM Software received FDA clearance for Centiloid scaling in PET imaging for Alzheimer’s disease.

Read the full article at: hitconsultant.net

Let’s take a look at how NLP is transforming how healthcare systems utilize unstructured data.

Read the full article at: www.kdnuggets.com

The new ApplySleep anti-snore smart wristband is designed to vibrate and prompt you to roll over when you’re snoring, while also tracking your sleep stats.

Read the full article at: www.forbes.com

Remnants of Hurricane Helene shut down a North Carolina factory that supplies critical IV fluids to hospitals across the country. There’s no timeline for when production will resume at the facility.

Read the full article at: www.npr.org

Sorry for this seemingly out of place article!   Just so happens that my grandniece has Niemann-Pick.  She is 9 years old and probably will not live much longer.  This is a step in the right direction though!  FDA approved Aqneursa (levacetylleucine) for the treatment of neurological symptoms associated with Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing at least 15 kg…

Read the full article at: www.fda.gov

In this InTechnology video, Camille chats with episode co-host Srini Ananth, Managing Director at Intel Capital, and guest Michael Dubrovsky, CPO and Co-Founder at SiPhox Health, about silicon photonics in personalized medicine. They discuss the technological advancements and advantages of silicon photonics, its applications in telecom and health diagnostics, the motivations behind Intel Capital’s investment in SiPhox, SiPhox’s innovative approach to personalized diagnostics, safeguarding personal health data, the role of AI in healthcare, and much more.

0:00 Introductions
2:08 What is silicon photonics?
4:21 How SiPhox uses silicon photonics
6:12 SiPhox’s at-home tests and devices
8:20 Intel Capital’s interest in SiPhox
11:18 Quantitative tests vs. on/off tests
13:07 SiPhox’s unique market testing approach
16:17 Security and AI for personal health data
19:25 Risk vs. opportunities
21:31 Wrap-up

Learn more about Intel Capital: https://www.intelcapital.com/

For more information, previous podcasts, and full versions, visit our website at https://intechnology.intel.com/

#siliconphotonics #personalizedmedicine #personalizeddiagnostics #SiPhox #IntelCapital

The views and opinions expressed are those of the guests and author and do not necessarily reflect the official policy or position of Intel Corporation.

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Intel, the world leader in silicon innovation, develops technologies, products and initiatives to continually advance how people work and live. Founded in 1968 to build semiconductor memory products, Intel introduced the world’s first microprocessor in 1971. This decade, our mission is to create and extend computing technology to connect and enrich the lives of every person on Earth.

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Scalable, At-Home Diagnostics: How SiPhox Delivers with Silicon Photonics | Intel
https://www.youtube.com/intel

Read the full article at: www.youtube.com

Withings announced that its Sleep Rx sleep apnea device has received clearance from the U.S. Food and Drug Administration (FDA).

Read the full article at: hitconsultant.net