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FDA| Healthcare FDA Regulation | Policy, News, Analysis, Insights - HIT Consultant

Ocutrx Acquires Spectrum AMT to Advance Capabilities for Medical Devices

by Health M&A 04/12/2023 Leave a Comment

Ocutrx Acquires Spectrum AMT to Advance Capabilities for Medical Devices

What You Should Know: Ocutrx Technologies, a global technology company developing medical devices with augmented reality (AR), extended reality (XR) and artificial intelligence (AI), acquires Spectrum Advanced Manufacturing Technologies, Inc., a Colorado-based electronics manufacturing and assembly company.With this acquisition, the consolidated Oxutrx_Spectrum company now has seven (7) process lines, including ISO Optics Lab capabilities,
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FDA & Cerner Enviza Collaborate to Develop AI Tools for Drug Safety

by Jasmine Pennic 04/10/2023 Leave a Comment

FDA & Cerner Enviza Collaborate to Develop AI Tools for Drug Safety

What You Should Know: - Cerner Enviza, an Oracle company, and FDA’s Sentinel Innovation Center are teaming up to develop AI tools to extract and assess clinical notes to better understand drug safety.   - Teaming with John Snow Labs, Cerner Enviza will use AI and NLP to develop tools to extract information from clinical notes within the EHR to better aid in better understanding the effects of medicines on large populations. The project known as the Multi-source Observational
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Biostage Raises $6M to Advance Clinical Trials

by Fred Pennic 04/07/2023 Leave a Comment

Biostage Raises $6M to Advance Clinical Trials

What You Should Know: Biostage, Inc., a cell-therapy biotechnology company with successful first-in-human experience in treating esophageal cancer and FDA approval to commence a clinical trial of the Biostage Esophageal Implant raises $6M from new and existing investors in a private placement of its shares of common stock.The funds will be used to accelerate the clinical development of Biostage’s lead product candidate, the Biostage Esophageal Implant, or BEI. The FDA has approved a
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Dot Compliance Launches First AI Based ChatGPT Powered eQMS for Life Sciences

by Syed Hamza Sohail 04/05/2023 Leave a Comment

Dot Compliance Launches First AI Based ChatGPT Powered eQMS for Life Sciences

What You Should Know: Dot Compliance, a leading provider of eQMS compliance solutions for the life sciences sector, has introduced an industry-first, ready-to-use AI-Based electronic Quality Management System for life sciences, powered by an embedded generative and predictive artificial intelligence.The system deploys ChatGPT combined with proprietary algorithms to optimize quality processes, automate tasks and help professionals working in quality assurance to focus on what really matters
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OXOS Medical Raises $23M to Deliver ”Radiology Department in a Box”

by Syed Hamza Sohail 04/05/2023 Leave a Comment

OXOS Medical Raises $23M Series A to Deliver ”Radiology Department in a Box”

What You Should Know: OXOS Medical, the MedTech innovator developing simple and safe X-ray solutions, announced a $23 million Series A funding from Parkway Venture Capital and Intel Capital, bringing its total funding to $45 million.OXOS continues to build on its traction across outpatient clinics, the military, the Veterans Administration, sports teams, hospitals, imaging centers, and bioskills labs. To help accelerate the company’s growth, Gregg Hill, Parkway Venture Capital co-founder and
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Q1 2023 Digital Health Funding Reaches $3.4B Across 132 Deals

by Syed Hamza Sohail 04/04/2023 Leave a Comment

Q1 2023 Digital Health Funding Reaches $3.4B Across 132 Deals

What You Should Know: 2023 started off with the hallmarks of a rebound year. While Q4 2022 signaled the tail end of the digital health funding cycle, January and February funding numbers began to suggest that sector investment was slowly but surely inching back upwards. Inflation was easing ever so slightly. Investors were rediscovering their confidence and launching new projects, signaling optimism in the sector, according to a new Rock Health report. However, recent news—the collapse of
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AI-Enabled Butterfly Network Lung Tool Receives FDA Clearance

by Fred Pennic 04/03/2023 Leave a Comment

AI-Enabled Butterfly Network Lung Tool Receives FDA Clearance

What You Should Know: - Today, Butterfly Network announced it received 510(k) clearance from the FDA for a groundbreaking AI-enabled tool named AI-enabled Auto B-line Counter that will help physicians assess adults’ lungs and accelerate providers’ abilities to make informed treatment decisions. Butterfly used data inputs from hundreds of sites across the country to train and develop its AI algorithms, offering potential for a broad and diverse range of age, gender, body mass index, ethnicity,
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Inato Raises $20M to Make Clinical Trials More Inclusive

by Fred Pennic 03/29/2023 Leave a Comment

Inato Raises $20M to Make Clinical Trials More Inclusive

What You Should Know: - Inato, a technology platform that connects pharma companies (trial sponsors) with community-based trial sites raises $20M in new funding (A2) led by Cathay Innovation with participation from existing investor Obvious Ventures and new investors La Maison and Top Harvest Capital. Inato works with many of the top 30 pharmaceutical companies worldwide to make clinical trials more inclusive. - The new funding will fuel Inato’s continued product innovation, international
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Exec Hires: Elucid Appoints Andrew Miller as CTO

by Digital Health Executive Appointments 03/29/2023 Leave a Comment

Exec Hires: Elucid Appoints Andrew Miller as CTO

What You Should Know: - Elucid, Inc., a medical technology company providing physicians with AI-powered imaging analysis software to assess cardiovascular disease, has hired Andrew Miller as its chief technology officer (CTO). - As CTO, Andrew will lead the technology strategy and oversee the engineering team’s execution. Elucid’s software is the only FDA-cleared non-invasive tool able to accurately characterize arterial plaque, simulating what pathologists would see under a microscope and
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 Are Hospitals Ready for Alzheimer’s Treatment Approval?

by John Showalter, MD, Chief Product Officer at Linus Health 03/20/2023 Leave a Comment

 Are Hospitals Ready for Alzheimer's Treatment Approval?

The FDA’s recent accelerated approval of Leqembi was welcome news across the Alzheimer’s community. However, few health systems, medical practices, or providers are prepared for the extraordinary public interest in a treatment for Alzheimer’s disease – especially not one targeting mild cognitive impairment (MCI) and early dementia due to Alzheimer’s disease – that is likely headed their way soon. The unprecedented scale of the public health and marketing campaigns, the high prevalence of MCI in
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