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

Talking about Cybersecurity Vulnerabilities in Medical Devices Shouldn’t be Taboo

by Nastassia Tamari, Director of Information Security Operations for BD 05/17/2021 Leave a Comment

Talking about Cybersecurity Vulnerabilities in Medical Devices Shouldn’t be Taboo

According to the National Vulnerability Database, 18,353 vulnerabilities were reported in 2020. That’s nearly three times the volume of vulnerabilities reported five years ago, and higher than any year in the previous two decades. Given the rise in connected devices, this increase is not entirely unexpected. If that’s the case, shouldn’t we be seeing more vulnerability disclosures related to medical devices?  The U.S. Department of Homeland Security Cybersecurity and Infrastructure
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FDA Approves First Ortho-K Contact Lens to Manage Myopia

by Fred Pennic 05/12/2021 Leave a Comment

FDA Approves First Ortho-K Contact Lens to Manage Myopia

What You Should Know: - Today, Johnson & Johnson Vision announced that the U.S. Food and Drug Administration (FDA) has approved ACUVUE® Abiliti™ Overnight Therapeutic Lenses, the first and only orthokeratology (ortho-k) contact lens for the management of myopia.   - Myopia, or ‘nearsightedness,’ is a chronic and progressive disease. Research shows that myopia will affect half of the world’s population by 2050,
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Bose Launches First FDA-Cleared DTC Hearing Aids

by Jasmine Pennic 05/12/2021 Leave a Comment

Bose Launches First FDA-Cleared DTC Hearing Aids

What You Should Know: - Bose is entering the digital health market launch of Bose SoundControl Hearing Aids – the first FDA-cleared, direct-to-consumer hearing aid.    - Weighing 3 grams each, the new SoundControl™ Hearing Aids are developed for adults with perceived mild to moderate hearing loss. Eight batteries are included in total, and one lasts up to four days when used 14 hours daily. They can be replaced wherever hearing aid batteries are sold and easily changed via a
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To Advance Health Equity, Put Real-World Cancer Data to Work

by Dr. Robert S. Miller, Medical Director of CancerLinQ 03/26/2021 Leave a Comment

To Advance Health Equity, Put Real-World Cancer Data to Work

Despite decades of scientific progress against cancer, access to treatment remains highly unequal. Some of the reasons — like institutional racism and poverty — are a reflection of our broader society. Other inequities may go unrecognized but are no less damaging. People with underlying health conditions, for example, may be excluded from clinical trials, preventing them from accessing leading-edge treatments and limiting the evidence available to guide their care. With multiple drivers of
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AppliedVR Lands $29M for VR Platform to Treat Chronic Pain

by Fred Pennic 03/23/2021 Leave a Comment

AppliedVR Lands $29M for VR Platform to Treat Chronic Pain

What You Should Know: - AppliedVR, a Los Angeles, CA-based company advancing the next generation of digital medicine, today announced $29 million in Series A funding, bringing its total funds raised to date to $35 million. The round, which includes key investors F-Prime Capital, JAZZ Venture Partners, Sway Ventures, GSR Ventures, Magnetic Ventures and Cedars-Sinai, will fuel the company’s growth as it pursues full FDA approval over the next year. - Founded in 2015, AppliedVR provides
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3 Ways Providers Can Navigate COVID-19 Vaccination Rollout Successfully

by Lisa Romano, MSN, RN, Chief Nursing Officer at CipherHealth 03/17/2021 Leave a Comment

Telehealth Helped Me Beat COVID-19, But it’s Just A Start

The New Year brings hope and promises that an end to the COVID-19 pandemic is in sight. With two vaccines authorized by the FDA for emergency use, and close to 3 million healthcare workers already vaccinated, there is hope that this virus will be eradicated and life will begin to return to normal by year’s end.   However, for the frontline healthcare workers still treating escalating case volumes, the physical and emotional toll is devastating. With another surge forecasted for
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Spectrum Health Taps TytoCare to Expand Telehealth Offerings

by Fred Pennic 03/15/2021 Leave a Comment

Spectrum Health Taps TytoCare to Expand Telehealth Offerings

What You Should Know: - Spectrum Health, a not-for-profit, integrated health system based in West Michigan has announced a partnership with TytoCare to expand their telehealth offerings. - The integration of TytoCare into Spectrum Health’s virtual care offering will enhance the health system’s ability to diagnose and treat patients remotely with in-depth, physical examinations during video visits. In an initial pilot with Spectrum Health employees
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AI-Powered COVID-19 Solution Reduces Report Turnaround Times by 30%, Study Finds

by Jasmine Pennic 03/15/2021 Leave a Comment

AI-Powered COVID-19 Solution Reduces Report Turnaround Times by 30%, Study Finds

What You Should Know: - The Moscow Center for Diagnostics & Telemedicine found that the introduction of RADLogics’ AI-Powered solution into radiology workflow to analyze Chest-CT scans during the COVID-19 pandemic reduced report turnaround time by an average of 30 percent, which is equivalent to 7 minutes per case. - The study was conducted over two separate phases with the first taking place between April 30, 2020 to June 18, 2020 and the second taking place between June 18, 2020 to
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Ambulatory Considerations for Remote Patient Monitoring Technologies

by Jiang Li, CEO of VivaLNK 03/15/2021 Leave a Comment

Ambulatory Considerations for Remote Patient Monitoring Technologies

The use of healthcare technology solutions in clinical settings is a time-tested conventional practice, and it’s becoming more commonplace in remote patient monitoring (RPM) as supporting technologies drive more innovation. With the broad range of care encompassed by the term “RPM,” there are a number of factors that can impact the overall effectiveness of monitoring patient vitals and other physiological parameters in remote, non-clinical situations. When a patient transitions from a
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BioIntelliSense Partners with Leukemia & Lymphoma Society for Continuous Monitoring in Clinical Trials

by Jasmine Pennic 03/05/2021 Leave a Comment

DoD Awards $2.8M to Philips & BioIntelliSense to Validate Wearable for Early COVID-19 Detection

What You Should Know: -BioIntelliSense announced it has entered into a strategic partnership with The Leukemia & Lymphoma Society (LLS) to incorporate the BioSticker™ platform in clinical trials of hematological cancer patients. - The LLS clinical trials will include use of the BioSticker medical device for the continuous collection of vital sign and physiological data which includes temperature, heart rate, respiratory rate at rest, activity level and body position. The BioSticker
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