Tag Archives: FDAcopilot

Huma’s Transition from Patient Monitoring Apps to a Cloud Platform Enhanced by AI

Huma’s Transition from Patient Monitoring Apps to a Cloud Platform Enhanced by AI

Huma, initially established in 2011 as a patient monitoring software company, has evolved significantly, particularly during the COVID-19 pandemic when its Medopad technology was used by the U.K.’s National Health Service to monitor COVID-19 patients remotely. Currently, in 2024, Huma is making strides towards revolutionizing healthcare digitization, evidenced by their recent announcement of raising $80 […]

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Axena Health and UpScriptHealth Team Up to Offer Telehealth Services for Women

Axena Health and UpScriptHealth Team Up to Offer Telehealth Services for Women

Axena Health, known for its innovative digital therapeutic solutions for women’s pelvic health, has collaborated with telehealth company UpScriptHealth to enhance the accessibility and convenience of consultations and treatments for women experiencing urinary incontinence. This partnership allows women to benefit from UpScriptHealth’s direct-to-consumer telehealth services, helping them address symptoms of urinary incontinence effectively. The key […]

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FDA Issues Warning Letter to Manufacturer of Defibrillator Batteries

FDA Issues Warning Letter to Manufacturer of Defibrillator Batteries

The Food and Drug Administration (FDA) recently issued a warning to Amco International Manufacturing & Design, a producer of batteries for Automated External Defibrillators (AEDs) used in devices distributed by prominent companies like Philips, Stryker, and Zoll. This warning stemmed from Amco’s continued distribution of these batteries without obtaining the required premarket approval (PMA), a […]

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Stryker Set for ‘Very Active’ M&A and Orthopedic Robot Launches in Second Half

Stryker Set for ‘Very Active’ M&A and Orthopedic Robot Launches in Second Half

Stryker Corporation has demonstrated robust financial and operational performance in its most recent quarterly report, showcasing a dynamic push in both its technologies and market expansion strategies. In the second quarter, the company reported revenue of $5.42 billion, marking an 8.5% increase from the previous year. The net income also showed a healthy growth, amounting […]

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FDA Officials Highlight Advantages of AI Lifecycle Management

FDA Officials Highlight Advantages of AI Lifecycle Management

Food and Drug Administration (FDA) officials have recently delved into the potential of lifecycle management to tackle the unique challenges posed by generative artificial intelligence (AI) in the healthcare sector. In a detailed blog post published by the FDA’s Digital Health Center of Excellence (DHCoE), the agency’s leaders discuss their ongoing efforts to thoroughly map […]

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Preventing the Next Wave: A Strategic Approach to Enhance Covid-19 Vaccine Adoption

Preventing the Next Wave: A Strategic Approach to Enhance Covid-19 Vaccine Adoption

Over four years since the initial outbreak, COVID-19 remains a significant health issue, leading to substantial hospitalizations and deaths despite no longer defining daily life for many. Almost 20% of U.S. adults endure long-term symptoms ascribed to Long COVID, highlighting the ongoing impact of the pandemic. Despite the immense benefits of vaccines during the pandemic, […]

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Patient Describes Daily Life with Diabetes at FDA’s Inaugural Home Health Hub Meeting

Patient Describes Daily Life with Diabetes at FDA’s Inaugural Home Health Hub Meeting

During a session aimed at enhancing home healthcare for diabetes patients, Arianna Gehan, co-founder and CEO of Daia Diabetes, described the daily challenges of managing her Type 1 diabetes, emphasizing the overwhelming experience of alarm fatigue from numerous notifications on her insulin pump and continuous glucose monitor. This session was part of the Food and […]

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Fostering Innovation in Clinical Trials Through AI-Focused Regulation at the FDA

Fostering Innovation in Clinical Trials Through AI-Focused Regulation at the FDA

In the realm of clinical trials, innovation is a critical necessity to expedite drug development. However, the slow evolution of U.S. clinical trials systems, due in part to resource limitations at the U.S. Food and Drug Administration (FDA), has dulled the pace of critical advancements needed in this sector. Traditionally reliant on pharmaceutical companies to […]

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Clarapath, a robotics company, secures $36M in funding along with other digital health investments.

Clarapath, a robotics company, secures $36M in funding along with other digital health investments.

Medical robotics company Clarapath recently secured $36 million in a Series B-1 funding round, led by Northwell Ventures. With this latest injection of capital, the company’s total funding has reached $75 million. New investors included Ochsner Ventures, CU Healthcare Innovation Fund, and Mayo Clinic. Based in New York, Clarapath has developed SectionStar, an autonomous AI-driven […]

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