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Medical Devices | Policy & Regulation News, Analysis, Insights - HIT Consultant

Medical Devices Cleared or Approved by FDA in 2022

by Fred Pennic 08/29/2022 Leave a Comment

Food and Drug Administration - FDA title=Food and Drug Administration - FDA _Medical Devices Cleared or Approved by FDA in 2022

The medical device industry is booming and shows no signs of slowing down. In 2022, the FDA (Federal Food and Drug Administration) will clear or approve over 1,000 medical devices. This is great news for patients who stand to benefit from the latest and greatest technology, but it can be tough for hospitals and doctors to keep up with all of the new devices on the market.  Here's a breakdown of some of the most anticipated otc medical devices that have already received FDA approval. Some
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EMPI/MPI: An End-to-End Approach to Patient Data Integrity

by Lora Hefton, Executive Vice President, Harris Data Integrity Solutions 08/19/2022 Leave a Comment

EMPI/MPI: An End-to-End Approach to Patient Data Integrity

Maintaining patient data integrity is more complicated than ever; cybersecurity threats loom, patients are taking more ownership of their care (self-registration, for example) and health system merger activity is on the rise. It can make the quest for the ever-elusive 1% maximum duplicate rate seem, at times, unattainable. But a secure, accurate, and duplicate-free MPI/EMPI can be achieved. It just requires a multi-pronged approach to protect data throughout its journey into a health system
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Connected Devices Selection: Considerations for A Digital-First Approach to Data Collection

by Mark Mentzer, Senior Director, Business Development, Connected Devices and eCOA, IQVIA 08/15/2022 Leave a Comment

Connected Devices Selection: Considerations for A Digital-First Approach to Data Collection

In recent years, digital health technologies (DHTs) have significantly changed the way we collect data within clinical trials. This is partially due to the overarching industry shift toward patient-centricity, but in some cases, it is also due to the commercial availability of powerful technology solutions not previously feasible for use in medical devices. In the past, nearly all patient data have traditionally been acquired by purpose-built machines manufactured by relatively small-scale
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Digital Front Doors Create Personalized Patient Experience

by Aan Chauhan, Chief Technology Officer, Mindtree 08/09/2022 Leave a Comment

The Digital Front Door to Patient-Centric Healthcare

Heightened patient expectations are changing the way healthcare services are delivered, from the way patients receive care to the way they pay for services and manage their conditions. A need for greater patient-centricity is changing the way payers, providers, and healthcare services organizations do business. The digital front door is an ecosystem of technologies patients use to engage with healthcare, starting from when they detect symptoms, to when they pay or receive post-appointment care.
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What is the Potential for Digital Twins in Healthcare?

by David Talby, CTO at John Snow Labs 08/08/2022 Leave a Comment

NLP is Raising the Bar on Accurate Detection of Adverse Drug Events

Digital twins are virtual representations of an object or system that spans its lifecycle, is updated from real-time data, and use simulation, machine learning and reasoning to help decision-making (IBM). In most cases, this helps data scientists understand how products are operating in production environments and anticipate how they may behave overtime. But what happens when a digital twin is that of a human being?  By using digital twins to model a person, you can use technologies like
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Healthcare & Life Science M&A Activity Plummets 1H’22

by Syed Hamza Sohail 08/05/2022 Leave a Comment

Healthcare & Life Science M&A Activity Plummets 1H’22

What You Should Know: - The index of Healthcare & Life Science equities tracked by Stout was down 16.8% in Q2 2022, which was in line with the S&P 500 decline of 16.4%. - Healthcare & Life Science M&A activity plummeted to 338 deals in Q2 2022 versus 535 in Q2 2021 and a record 565 deals in Q4 2021. The report reveals credit markets likely to tighten, but a healthy level of M&A is expected to continue in the growing and defensive healthcare sector. Key Trends and
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Caption Health Receives CE Mark for AI Ultrasound Tech

by Syed Hamza Sohail 07/19/2022 Leave a Comment

Caption Health AI Awarded FDA Clearance for Point-of-Care Ejection Fraction Evaluation

What You Should Know: - Caption Health, the leader in using artificial intelligence (AI) and services to improve heart ultrasound access, today announced that it has received a CE Mark for its Caption AI™ technology platform. - This certification represents the first step in making Caption Health’s industry-leading technology platform available outside the US, and highlights the company’s strong clinical and regulatory track record as it uses AI and ultrasound to deliver better cardiac
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Designing Digital Transformation for Life Sciences: Building Resiliency When Disruption is the New Normal

by Dan UpDyke, Strategic Marketing Manager Life Sciences at Rockwell Automation 07/19/2022 Leave a Comment

Designing Digital Transformation for Life Sciences: Building Resiliency When Disruption is the New Normal

The ability to navigate constant disruption is a prerequisite for success in today’s life science industries. To maintain their competitive advantage, businesses in this sector need to drastically boost their organizational agility and resiliency in the face of unprecedented market conditions and operational challenges. In order to achieve this, organizational digital transformation (DX) is necessary. However, with so much in flux, it can be difficult to see the big picture in trying to plan and
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FDA Clears Eko’s Heart Disease Detection AI for Adults and Pediatrics

by Fred Pennic 07/12/2022 Leave a Comment

FDA Clears Eko’s Heart Disease Detection AI for Adults and Pediatrics

What You Should Know: - Today, Eko, a digital health company advancing heart and lung disease detection, has announced the FDA has issued clearance for its Eko Murmur Analysis Software (EMAS), the first and only machine learning algorithm to screen for valvular heart disease (VHD). - The next generation of Eko’s murmur detection capabilities grants Eko the first and only smart stethoscope on the market that can identify and
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Path to Predictive Patient Data: Silencing The Noise of Healthcare

by Shane Cooke, CEO and President of Etiometry 07/06/2022 Leave a Comment

Consolidated Patient Data: Silencing the Noise of Healthcare

As the healthcare industry is experiencing major changes in the wake of the pandemic, how do we cut through the noise of beeping monitors and the constant influx of data each patient produces in a given moment to ensure optimal care, especially for critically ill patients? Instead of adding a new beep or silencing the existing ones, why not build a path through the noise with data? The Path to Predictive Data  Nearly every advancement in healthcare has been centered around data, with
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