What You Should Know:
- Selux Diagnostics has been granted 510(k) clearance from the US FDA for its Next Generation Phenotyping (NGP) System — a rapid antibiotic susceptibility (AST) testing platform able to determine a bacteria’s susceptibility to a specific panel of antimicrobial agents.
- In vitro antimicrobial resistance test enables clinical labs to deliver targeted therapeutic results days faster than the current standard of care, clearing the path for personalized antibiotic
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FDA| Healthcare FDA Regulation | Policy, News, Analysis, Insights - HIT Consultant
SetPoint Medical Raises $80M to Advance Platform for Autoimmune Diseases
What You Should Know:
- Today, SetPoint Medical announced $80M in Series C equity and $65M led by new investors, Norwest Venture Partners and Viking Global Investors, with debt financing provided by Runway Growth Capital.
- The company is developing its novel platform for the treatment of chronic, inflammation-mediated autoimmune diseases and is initially focused on a potentially less immunosuppressive option for the treatment of rheumatoid arthritis (RA). More than 1.5 million people in
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22 Executive Digital Health Predictions to Watch in 2023
Jon Bloom, MD, CEO and Co-founder of Podimetrics
From a digital health perspective, 2022 was a reset year for many and a serious reality check. We went from sky high growth to the sky is falling, and in 2023 I think this market correction movement will continue forward. To me, the biggest surprise of 2022 was that despite the market tanking, digital health companies continued to truck forward with huge deals. This includes massive acquisitions like Amazon and OneMedical, as well as deals like
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7 Life Sciences Executive Predictions to Watch in 2023
Tracy Curley, CFO and interim CEO at iSpecimen
Focusing on the macroeconomic environment, which remains impacted by the lingering COVID-19 pandemic, there continues to be uncertainty about the strength of the global, Asia Pacific, UK and US economies. High-interest rates and a potential recession remain a concern for all market participants. At ISPC, we are closely monitoring the pace of specimen transactions. We believe that this industry can be resilient through a continued economic
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How Tech Can Improve Health Plan Performance & Star Ratings in 2023 & Beyond
The open-enrollment period that recently concluded for U.S. health plans was the first since the expiration of pandemic-linked changes to how Star Ratings were calculated. This is a period of major transition for the industry, with some health plans struggling to maintain their previous ratings and plan participants, who are now accustomed to home-based testing and treatment, expecting those services and features to continue. Fortunately, new technology can help health plans boost plan
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Exec Hires: GE HealthCare Names Taha Kass-Hout First Chief Technology Officer
What You Should Know:
GE HealthCare announced today that Taha Kass-Hout MD, MS has been named Chief Technology Officer (CTO) to lead the company’s new science and technology organization.
- Reporting to GE HealthCare President & CEO Peter Arduini, Dr. Kass-Hout will help drive GE HealthCare’s D3 precision care strategy, a framework and digital products that emphasize the company’s smart devices, aligned to disease states and enabled by digital. D3 brings data and insights together to
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Valencell Unveils Calibration-Free, Cuffless Blood Pressure Monitor
What You Should Know:
- Valencell, the company whose optical heart rate technology enabled the ability of wearables to accurately measure cardiovascular vitals during exercise, today announced plans to launch its own branded product line in the digital health sector as it concentrates efforts to bring solutions to market to manage chronic diseases.
- The company’s first product candidate being showcased at CES is focused on helping people monitor and manage hypertension by combining
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Q/A: Podimetrics CEO Talks Preventing Diabetic Amputations
Diabetes prevention is one of the biggest challenges in the healthcare industry as more than 37 million Americans (11.3% of the population) suffer from this debilitating chronic disease. As we close the year out, we sat down with Jon Bloom, MD, CEO and Co-founder of diabetic healthcare tech company Podimetrics to learn how the industry and his company are working to implement health equity change to serve patients living with advanced diabetes. The company’s FDA-cleared SmartMat provides a
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How Bluetooth Technology Is Bolstering the New Era of Hearing Accessibility
In August, the Food and Drug Administration established a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to moderate hearing loss to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription, or a fitting adjustment by an audiologist. The move intends to help make hearing aids more accessible and affordable for some of the 30 million U.S. adults currently experiencing hearing loss. Historically,
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Anumana & Pfizer Partner on Amyloidosis AI-ECG Algorithm Development
What You Should Know:
- Anumana, an AI-driven health technology company and portfolio company of nference, today announced a multi-year agreement with Pfizer for Anumana to develop an investigational artificial intelligence electrocardiogram algorithm (AI-ECG) designed to enable the early identification of patients who may be at risk of cardiac amyloidosis.
- Anumana will conduct a clinical validation trial and pursue De Novo classification for the algorithm as a
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