Search results for Devices & Diagnostics

Bridging the Diagnostics Gap: Deloitte Research Exposes Core Mismatch Between Manufacturers and Providers 

What You Should Know A new survey by the Deloitte Center for Health Solutions reveals that 62% of diagnostics manufacturer executives believe future growth depends entirely on adop...

Connected medical devices: Smarter care starts here

Connected medical devices are transforming healthcare and clinical trials, driving advances in patient care and next-gen therapies shaping the future.

How to Check MDM Diagnostics on Windows

Observability over Windows devices is made efficient through Mobile Device Management (MDM). This allows IT teams to control and secure Windows endpoints and carry out critical ope...

DT Research DT514LA Offers Trusted Bedside Support

Point-of-care technology has come a long way since the humble blood glucose meter for patients with Type 1 or Type 2 diabetes. Nurses and other team members provide bedside care to...

FDA Launches READI-Home Innovation Challenge: Opportunities—and Tensions—for Home-Use Device Developers

By Jennifer D. Newberger —

The future of vehicle diagnostics: Powering the EV transition

The global automotive industry is entering one of the most transformative periods in its history. Electrification is accelerating, emissions regulations are tightening across major...

FDA Seeks Input on Digital Health Technologies in Clinical Investigations for Drugs and Biological Products

By Adrienne R. Lenz, Principal Medical Device Regulation Expert —

Sensor-enabled smart device may detect PJI before diagnosis

NEW ORLEANS — Use of a sensor-enabled smart device implanted at the time of total knee arthroplasty may detect periprosthetic joint infection before diagnosis, according to results...

ECRI Urges Congress to Strengthen Regulatory Transparency for Digital Health and CDS Tools

What You Should Know ECRI, a nonprofit patient safety organization, submitted formal recommendations to the House Energy and Commerce Subcommittee on Health in April 2026. The orga...

Apple’s monitor cleared for radiology by FDA

Apple’s Studio Display XDR is taking an unexpected but very serious step into hospitals and radiology practices, with Apple confirming that its Medical Imaging Calibrator feature h...

Reimagining Medical Devices in the AI Era: The 3 Structural Shifts Driving Venture-Scale Growth

What You Should Know: In their newly released whitepaper, Medical Devices in the AI Era, Aegis Ventures outlines how the medical device sector has historically underperformed in ve...

FDA’s 2026 General Wellness Policy and What It Means for Manufacturers of Wearable Devices

Wearable devices are products worn on the body that use sensors and software to collect and display health or lifestyle information such as activity, sleep, or recovery trends.  Wh...

The Compliance Bottleneck in Connected Health: Why Cloud-Based Medical Devices Need a Different V&V Approach

Most verification and validation (V&V) frameworks in medical devices were built on a foundational assumption: the device you ship is the device that gets used. A fixed product,...

SDV survey: AI diagnostics top automakers’ priority list

Smart diagnostics and predictive maintenance top AI use cases in SDV, cited by 34% of respondents in a Sonatus and Omdia global survey The post SDV survey: AI diagnostics top autom...

The Rise of Digital Health: Where Does SaMD Fit In?

Digital health has shifted from an experimental category into a core part of modern care delivery. What once referred mainly to fitness apps, patient portals, and digitized records...

Cody Simmons, DermaSensor

Cody Simmons is the CEO of DermaSensor. I met him when he won the Digital Health Hub Foundation award for diagnostic tools last year. DermaSensor is a device designed to detect ear...

<![CDATA[Bridging the Precision Gap: Accelerating Clinical Adoption of Companion Diagnostics in Oncology]]>

How to Select a Medical Device Camera for FDA 510(k) and CE-Regulated Embedded Vision Systems - Vadzo Imaging FALCON USB...

VElectrical safety class, EMC characterization, sensor architecture, and OEM compliance documentation are the variables that determine whether a medical device camera integration c...

UChicago Medicine, Artisight partner on system-wide rollout of smart hospital platform

More than 1,800 devices will be deployed across patient rooms, post-anesthesia care units, operating rooms and UChicago’s new 575,000-square-foot cancer care facility, the organiza...

RAPID Response: CMS and FDA Team Up to Fast-Track Medicare Coverage for Breakthrough Devices

On April 23, 2026, the Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) jointly announced the Regulatory Alignment for Predictable...

CMS, FDA announce pathway to expedite access to certain medical devices for Medicare beneficiaries

The Centers for Medicare & Medicaid Services and the Food and Drug Administration April 23 announced a new pathway to expedite access to certain FDA-designated Class II and...

Using Digital Technologies to Enhance Patient Experience and Better Manage Supply Chain

Integrating connectivity into drug delivery devices as a way to improve patient engagement and adherence

Tandem Diabetes issues software device correction for insulin pump malfunction

Tandem Diabetes Care issued an urgent medical device correction to upgrade the software of its Tandem Mobi insulin pumps that can fail to deliver critical medicine to patients.

FDA Grants De Novo Classification to TytoCare’s AI Otoscopy Tool

The AI-driven software analyzes otoscopy videos to detect eardrum bulging, establishing a new regulatory category for ENT diagnostic aids.