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

Health-Tech C2Q:22 Preview: 5 Key Driving Factors to Watch

by Syed Hamza Sohail 08/23/2022 Leave a Comment

Executive Insights: Top Healthcare Predictions & Trends to Watch in 2020

What You Should Know: - David Larsen, healthcare IT and digital health analyst at BTIG published a note highlighting his preview for health-tech Q2 earnings. - Given high inflation rates, costs for traveling nurses, and light volumes in 2Q:22, he is cautious on stocks that sell into the acute care market in the near term. An Overview According to the report, there are many macro headwinds that continue to affect the HCIT sector and the broader market, including inflationary pricing
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POGO Blood Glucose Monitoring Now Available in Kroger Health Pharmacies Nationwide

by Jasmine Pennic 08/23/2022 Leave a Comment

POGO Blood Glucose Monitoring Now Available in Kroger Health Pharmacies Nationwide

What You Should Know:  - Intuity Medical, Inc., a commercial-stage medical technology and digital health company focused on making life with diabetes easier, today announced that the POGO Automatic® Blood Glucose Monitoring System is now available at the more than 2,200 U.S. pharmacies of Kroger Health, the healthcare division of The Kroger Co.  - With POGO Automatic Monitors and Cartridges now available at all Kroger Health pharmacy locations, the simplicity of One-Step testing
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GE Healthcare Makes Strategic Investment in AliveCor

by Syed Hamza Sohail 08/17/2022 Leave a Comment

AliveCor Launches KardiaMobile Card, World’s First Credit-Card-Sized Personal ECG

What You Should Know: - AliveCor, the global leader in FDA-cleared personal electrocardiogram (ECG) technology, recently announced its Series F Financing led by GE Healthcare. - The round also included participation from Pegasus Tech Ventures) and existing investors including Khosla Ventures, Bold Capital Partners, Qualcomm Ventures, and WP Global Partners. Providing End-to-End Cardiological Care Using Subscription Services AliveCor, Inc. is transforming cardiological care using deep
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Avenda Health Receives FDA Exemption for AI-Enabled Prostate Cancer Therapy

by Jasmine Pennic 08/12/2022 Leave a Comment

Avenda Health Receives FDA Exemption for AI-Enabled Prostate Cancer Therapy

What You Should Know: - Avenda Health, an AI healthcare company creating the future of prostate cancer care, has received FDA Investigational Device Exemption (IDE) for its FocalPoint ablation system. The IDE will allow the technology, powered by iQuest, to be used in a randomized control trial to show superiority over the standard of care for the treatment of prostate cancer.  - FocalPoint is Avenda Health’s focal laser ablation system designed to treat localized prostate cancer
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Sibel Health Raises $33M for Advanced Wearable Sensors for RPM

by Syed Hamza Sohail 08/09/2022 Leave a Comment

What You Should Know: - Sibel Health has recently closed a $33M Series B financing round, bringing Sibel's total funding to date to more than $50M. - In addition, Sibel has announced two new executive appointments. Jon Otterstatter, the former CEO and co-founder of Preventice (acquired by Boston Scientific in 2021), will join as chairman of the board. Matthew Banet, Ph.D., a world expert in advanced body-worn sensors and previously the CTO and co-founder of toSense and Sotera, joins as
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Mira Launches Ovum Wand to Predict Menopause and Monitor Fertility Status

by Jasmine Pennic 08/02/2022 Leave a Comment

Mira Launches Ovum Wand to Predict Menopause and Monitor Fertility Status

What You Should Know: - The FDA has listed Mira's new Mira Ovum Wand as an over-the-counter tool to detect the follicle-stimulating hormone (FSH) in urine. Starting October 2022, the product will be available to U.S. customers. The wands help monitor FSH levels to predict approaching menopause. They can also be used to monitor fertility and find possible causes of reproductive issues for women after 35. - Mira's new Ovum Wand provides lab-accurate detection of the follicle-stimulating
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Exo Acquires Medo to Make Ultrasounds Simple and Accessible

by Fred Pennic 07/26/2022 Leave a Comment

Exo Acquires Medo to Make Ultrasounds Simple and Accessible

What You Should Know: - Exo, a health information and devices company, today has announced it has acquired Medo, an FDA-cleared AI platform that makes ultrasound workflow faster, more reliable, and accessible to all.   -  By integrating Medo’s AI, Exo enables more caregivers in more settings to capture and interpret medical images – allowing faster and more accurate diagnoses and treatment. Make Medical Imaging as Easy as Snapping a Smartphone Photo Ultrasound imaging is
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Media Mix Transformation for Pharma Marketers: The Power of CTV & Digital Video

by Lauren Ohlsson, Lead of Industry Solutions, Pharmaceutical and Healthcare, at VDX.tv 07/26/2022 Leave a Comment

Media Mix Transformation for Pharma Marketers: The Power of CTV & Digital Video

Consumers continue to cut ties with traditional TV and cable services, prompting industries like the prescription pharmaceutical industry to evolve their marketing mix to accommodate emerging media.    Pharma advertisers spend billions on traditional TV advertising, but as streaming services began to experience explosive growth early in the pandemic, advertising strategies had to adapt. TV-centric advertisers relied on (and still rely on) dayparting (scheduling ads during certain times of the
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FDA Awards 510(k) Clearances for ZEUS System/Zio Watch

by Fred Pennic 07/22/2022 Leave a Comment

iRhythm + Verily Awarded FDA Clearances on ZEUS System/Zio Watch

What You Should Know: - Today, iRhythm (a digital health company) and Verily (Alphabet’s life sciences research organization) announced joint FDA 510(k) clearances for the ZEUS System and Zio Watch. Together they create an integrated, prescription-based solution that will improve clinician workflows, care pathways and the patient experience.  - The ZEUS System is the AI algorithm and solution component of the Zio Watch – a clinical grade, long-term and noninvasive wearable that not only
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Oncoustics Raises $5M for AI-Driven Point-of-Care Diagnostics

by Syed Hamza Sohail 07/22/2022 Leave a Comment

Oncoustics Raises $5M for AI-Driven Point-of-Care Diagnostics

What You Should Know: - Oncoustics, San Francisco, CA-based ultrasound-based tissue characterization solutions announces the initial close of a $5 million+ seed round of funding to advance its SaMD (software as a medical device) technology for the low-cost assessment of structural diseases at the point of care. - Oncoustics’ first products will focus on liver disease, one of the fastest-growing causes of morbidity and mortality in the world. The round is co-led by Creative Ventures
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