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Consumer diagnostics will be one of several discussions at the INVEST Digital Health conference focused on power shifting to the consumer in healthcare. The conference is scheduled...
Why the flood of consumer wellness devices demands clear boundaries between lifestyle improvement and clinical diagnostics The post The Imperative of Distinguishing Medical-Grade D...
Introduction The healthcare sector in India is witnessing a change with the advancement of technology. The use of medical devices is not limited to wards and laboratories anymore....
By Mary Bass & Jennifer D. Newberger —
Top News Connected health devices company Withings launches Withings Medical ...
CMS unveiled new details of its new RAPID pathway, which is designed to close the gap between FDA approval and Medicare coverage for breakthrough medical devices. Industry reaction...
Matching the right patient to the right therapy now requires understanding what’s driving the apnea, not just how often it occurs. Closing that gap means rethinking what sleep apne...
Modern healthcare depends on timely diagnostic data to guide treatment decisions, particularly for complex conditions like liver disease. As medical device technology advances, the...
LG Electronics has launched a new diagnostic monitor cleared by the U.S. Food and Drug Administration (FDA) as a medical device, expanding its lineup of business-to-business (B2B)...
The U.S. Food and Drug Administration has issued a final order moving certain laboratory tests used to help guide treatment with approved cancer drugs from...
A Sensor for Every Symptom: FDA Puts $1.1 Million Behind Digital Health in Drug Trials Anonymous (not verified) Sun, 08/02/2026 - 21:27 pharmagather item url...
Most enterprises connect with their customers through a device. Whether it’s using a mobile app to order a product, contact customer service, view content, or manage their account,...
The Case of the Self-Healing Device The evidence board Apple’s Declarative Device Management (DDM) now extends to app deployment, letting devices detect and fix their own failed in...
€4 million European-funded DIGICAP project brings together 19 organizations to replace document-based conformity assessments with machine-readable data. DistillerSR named one of fi...
By Jennifer D. Newberger —
By Jennifer D. Newberger & Adrienne R. Lenz, Principal Medical Device Regulation Expert —
The FDA has approved Abbott’s first-of-its-kind bio-wearable sensor that can warn diabetics of increased ketones that can lead to diabetic ketoacidosis.
The US Food and Drug Administration named Dexcom as the first manufacturer selected for its Technology-Enabled Meaningful Patient Outcomes pilot on Tuesday. The programme, known as...
In their letter to the Union Health Minister JP Nadda, they said, medical devices continue to be seen as “an adjunct to pharmaceuticals”, despite scientific, engineering and regula...
Check out today’s featured companies who have recently raised a round of funding, and be sure to check out the full list of past healthcare IT fundings. Vivid Dx Raises $15M to Hel...
Diagnostic Image Exchange Helps Clinicians and Patients Get Answers Sooner ...
Soon, diagnosis of diseases and injuries from X-rays will be possible in the most far-flung areas of J&K, even where a specialist doctor is not available. The procurement proce...
A few minutes of interaction with a digital tablet and speaking can reveal patterns that once required advanced imaging, years of observation, or were just completely undetectable....
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