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How Will New FDA Hearing Aid Regulations Impact Health Plans?

HIT Consultant

First, let’s examine the new regulatory framework the FDA established. – Prescription hearing aids will require a consumer to have a prescription for a hearing aid from a physician, audiologist or a licensed hearing instrument specialist. These OTC hearing aids do not require a prescription. . yet is largely untreated.

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Qualcomm Life signs deal with AlertWatch, PeriGen, and other digital health deals

Mobi Health News

Qualcomm Life announced an exclusive licensing agreement with AlertWatch, creator of an FDA-cleared intelligence care software that assists in the care of patients in the operating room. The deal will give Qualcomm Life the exclusive rights to sell AlertWatch, which the company plans to showcase at HIMSS 2018.

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Cybersecurity Vulnerabilities in Implantable Medical Devices

HIT Consultant

That number more than doubled from 2018 to 2021, marking an unfortunate milestone — and indicating the issue will continue worsening. Food and Drug Administration (FDA). Health Sector Cybersecurity Coordination Center and the Office of Information Security, the frequency of healthcare data breaches has trended upward since 2012.

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Analysis: Seeking Balance in the Hyperactive Mental Health Tech Market

HIT Consultant

Notable transactions in the consumer and member tech category include: Pear Therapeutics , software-based medicine provider, made its mark in 2017 as its tool became the first digital therapeutic approved by the FDA with claims to improve clinical outcomes.

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Cuffless Blood Pressure Monitoring – Not for the Faint-of-Heart (Pun Intended)

Healthcare IT Today

Moreover, the market for FDA-approved BP monitoring solutions that encourage routine measurements is well into the billions [ 22 , 23 ]. For some R&D efforts, the answer is quite simple – FDA approval has simply not been achievable due to the inability to pass critical performance standards.

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Better Health Care Tests, Faster

Healthcare IT Today

Esquivel says, “ixlayer partners with CLIA-accredited laboratories and performs a rigorous vetting process of their validations protocols and operational capabilities from the licensing perspective on a state-by-state basis. Hydreight , founded in 2018, offers at-home healthcare and wellness services in all 50 U.S.

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CareCloud CEO predicts what's around the corner for telehealth

Healthcare IT News - Telehealth

We launched our first fully integrated telehealth solution in the 2018-2019 timeframe. As more and more wearable devices are becoming common in the technology, they have even started to get some FDA approvals as well. But one priority to address is the licensing-based requirement.

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