Medical Device Integration

FDA Launches Center of Excellence to Advance Digital Health

September 24, 2020 - FDA recently announced that it’s launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDHR) to advance digital health technology In the announcement yesterday, FDA said it will work to boost the advancement of mobile devices, software-as-medical-device (SaMD), wearables when used as a...

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C4MI Launches Program to Verify Medical Device Interoperability

by Fred Donovan

The Center for Medical Interoperability (C4MI) has launched an industry-wide program to verify medical device interoperability. The program, called C4MI Verified, is designed to accelerate the...

Mercy Unveils Health Data Network to Pool Clinical Data for Analysis

by Fred Donovan

St. Louis-based Mercy health system, through its Mercy Technology Services arm, has launched a health data network to pool clinical data from across the United States. Mercy plans to partner with...

HMI Technology, Healthcare Robotics Help Stroke Patient Recovery

by Fred Donovan

Human-machine interface (HMI) technology, healthcare robotics, and brain stimulation are being used by Swiss researchers to help rehabilitate stroke patients. When used together and personalized for...

St. Joseph’s/Candler Deploys Patient Navigation System at Pooler

by Fred Donovan

Savannah, GA-based St. Joseph's/Candler is rolling out a patient navigation system to help patients and visitors find their way around its new 83,600 square-foot Pooler medical campus. The Pooler...

Information Explosion Makes Data Tracking in Healthcare Essential

by Fred Donovan

Data tracking has become increasingly important with the explosion of information in the healthcare environment. The benefits of tracking data are synchronizing large data sets generated by...

Verma Outlines Plan to Lower Hurdles to Medical Device Innovation

by Fred Donovan

CMS Administrator Seema Verma laid out her agency’s strategy to reduce barriers to medical device innovation in the Medicare program, during a May 2 speech at the Medical Device Manufacturers...

FDA Proposes Rules for Devices Using Artificial Intelligence

by Fred Donovan

The Food and Drug Administration (FDA) has released a proposed regulatory framework for medical devices that use artificial intelligence (AI) algorithms. The agency is seeking industry feedback on the...

Healthcare Internet of Things Market To Grow at 11% CAGR to 2022

by Fred Donovan

The global healthcare Internet of Things (IoT) market is forecast by Zion Market Research to increase at a robust 11 percent compound annual growth rate (CAGR), reaching $14.7 billion by 2022. Market...

Greater Medical Device Connectivity Prompts FDA Process Revision

by Fred Donovan

The FDA is updating its voluntary 510(k) approval process to take into account growing medical device connectivity and interoperability, the agency announced Nov. 26. The FDA explained that the...

Smart Device Growth Strains Health IT Infrastructure

by Elizabeth O'Dowd

The more devices organizations add to their health IT infrastructure, the more entities need the devices to have smart capabilities. Internet of Things (IoT) and other smart devices need some form of...

Half of Orgs Unprepared for HIT Infrastructure Digitization

by Elizabeth O'Dowd

Over half of healthcare and life sciences organizations are planning major health IT infrastructure changes in the near future, but a survey found that most are currently unprepared to begin the...

FDA Recognizes Medical Devices in Health IT Infrastructure

by Frank Irving

The U.S. Food and Drug Administration (FDA) appears intent on positioning medical devices within the realm of health IT infrastructure. Twice this month, the FDA has issued draft guidance on medical...

Mobile Device Integration: Are Tablets a Dying Breed?

by Frank Irving

Smartphones and tablet computers have carved out a respectable slot for use by professionals in healthcare settings. However, if consumer trends are a leading indicator, hospital and health system...

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