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Digital Health


Harry Glorikian
April 22, 2022
Harry Glorikian
Soapbox

Telemedicine Moved Forward During the Pandemic. Our Policies and Regulations Need to Catch Up

By Harry Glorikian

Outdated policies and regulations threatens to bring progress to a standstill, restrict vital telehealth access to millions of Americans, and exacerbate health inequities.

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Brian Stallard, AAMI
April 19, 2022
Brian Stallard, AAMI
MEDdesign

A State of Alarm:
Research Advances for Medical Warning Systems

By Brian Stallard

You’d think there’s not much to the concept of an alarm. A warning sounds in a room, or a red light flashes, and it has your attention. You know something must be wrong. But in a setting where a cacophony of alarming lights and sounds beset healthcare workers on a regular basis, these essential systems become increasingly easy to miss or ignore.

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authentication, QR code
April 14, 2022
authentication, QR code

Patient-Operated Devices Are Changing the Healthcare Landscape

By Philip Remedios

Patient-administered healthcare is one of the fastest-growing segments in the medtech industry. When the patient becomes the operator, usability requirements are vastly different than those of trained clinicians, which elevates considerations in the design process.

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FDA
April 12, 2022
FDA

FDA Issues Cybersecurity Draft Guidance, Wants Devices Designed Securely

By MedTech Intelligence Staff

With the ever-increasing adoption of connected devices, the agency is emphasizing the need for effective cybersecurity.

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Pradeep Goel, Solve.Care
April 8, 2022
Pradeep Goel, Solve.Care
Soapbox

Giving Control Back to the Patient

By Pradeep Goel

Blockchain technology helps support the goal of decentralizing the healthcare sector and providing patients with the information they deserve about their own healthcare data.

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Wearable Cloud, Medical Device Connectivity
April 6, 2022
Wearable Cloud, Medical Device Connectivity

Virtual Event Explores User Management and Patient Engagement in Connected Care

By MedTech Intelligence Staff

Experts will explore how digital technologies have opened up new opportunities for patients, providers and medtech manufacturers.

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FDA
March 29, 2022
FDA

FDA Seeks $60 Million in Funding to Improve Access to Safe and Effective Medical Products

By MedTech Intelligence Staff

The total $8.4 billion fiscal year 2023 budget request is 34% higher than the agency’s 2022 appropriated funding level.

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Joerg Schwarz, Infor
March 28, 2022
Joerg Schwarz, Infor
Soapbox

Why the Future of U.S. Patient Care Begins with Interoperability

By Joerg Schwarz, Ph.D.

The combination of medtech progress with strides in modern healthcare interoperability will enable preventive care in unprecedented ways.

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Etienne Nichols, Greenlight Guru
March 24, 2022
Etienne Nichols, Greenlight Guru
Soapbox

Three Things You Need to Know About FDA QSR and ISO 13485 Harmonization

By Etienne Nichols

New changes mean new challenges, but global harmonization could make things easier for device manufacturers in the long run.

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Bob Tilling, Kallik
March 22, 2022
Bob Tilling, Kallik
MEDdesign

The Future Is Now:
Digital Technologies that Are Revolutionizing the Medical Device Industry

By Bob Tilling

2022 is now upon us, hopefully marking the end of a very disruptive couple of years. Global challenges, from supply chain shortages to remote services, have driven digital innovation and change in the way we work across all sectors. The medical device industry is no different and going forward, having learned from the experiences of 2021.

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Columns

May 12, 2025

FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline

The FDA plans to expand generative AI capabilities—across all centers using a secure, unified platform.

April 18, 2025

Leveraging AI for Transforming Patient Care and Enhancing Clinician Experience in EMRs

By Josh Sol

As healthcare pushes forward in digital transformation, AI has emerged as a critical tool in optimizing electronic medical records. EMRs remain both vital and frustrating. Clinicians wrestle with usability, while patients struggle with engagement and access. By integrating AI thoughtfully and securely, we can create a more intuitive, efficient and user-centric experience for both groups.

April 8, 2025

Increased productivity through AI?

By Dr Christian Johner

MTI Viewpoint: I expect fundamental changes to our medical device ecosystem; not all companies will survive them. The ability to consistently use AI will also determine who will be among the survivors and even the winners. AI will not only be part of the devices but also an internal tool.

April 4, 2025

What’s Missing in MedTech Innovation? The Journey Toward Plug-and-Play Device Interoperability

By Dr. Charles Jaffe, Todd Cooper
Interoperability

For over four decades, the medical device industry has wrestled with fragmented data exchange and proprietary integrations. HL7’s Device Interoperability FHIR Accelerator initiative offers a vendor-neutral framework to finally achieve plug-and-play interoperability—unlocking scalable, AI-powered MedTech innovation and improving patient outcomes.

March 28, 2025

Regulation vs. Deregulation:
Finding the Right Balance for AI-Driven Healthcare

By Mika Newton
Regulations

AI’s reach depends on the environments in which it operates as well as how it is developed and deployed, highlighting a fundamental debate on whether we should push for regulation or opt for free-market-driven deregulation.

February 7, 2025

Why Quality Culture is the Key for Tech Entrants in Healthcare

By Attrayee (Atty) Chakraborty, MS, MSc., Dinesh Puppala, MS, RAC

In the healthcare industry where patient lives are at stake, quality culture is a cornerstone principle extending beyond operational efficiency. It has profound effects on patient outcomes. As tech continues to disrupt healthcare, how do technology companies build a robust quality culture to succeed in healthcare?

January 31, 2025

FDA Safety Communication: Cybersecurity Vulnerabilities with Certain Patient Monitors from Contec and Epsimed

FDA Logo

Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to raise awareness about cybersecurity vulnerabilities in Contec CMS8000 patient monitors and Epsimed MN-120 patient monitors. These medical devices are used in health care and home settings for displaying information, such as the vital signs of a patient, including temperature, heartbeat, and blood pressure.

January 22, 2025

Chronic Disease Under the New US Administration:
Renewed focus can be opportunity for device makers

By Josephine Ornago

Leveraging awareness communications to grasp the potential opportunity for medical devices designed to monitor health and chronic illnesses offered by the new US administration.

  • Digital Health
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