What You Should Know:
– Philips Respironics, a subsidiary of Royal Philips, has finalized a consent decree with the US Department of Justice (DOJ) and Food and Drug Administration (FDA) to address issues raised during…
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Current solutions for remote health monitoring can be seen as invasive by patients and mostly do single variant intermittent tracking. FDA clearance brings one of Europe’s most advanced real-time continuous remote monitoring systems to…
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An Overview of the Wearable Market in Healthcare
MarketsandMarkets suggests that the global market for wearable healthcare devices will approach $70 billion by 2028, with annual growth in the market exceeding 11 percent per year….
An over-the-counter continuous glucose monitoring (CGM) solution developed by Dexcom called Stelo has received clearance from the Food and Drug Administration (FDA).Available without the need for a prescription, the wearable biosensor boasts a battery…
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Lantheus Holdings, Inc. celebrates FDA approval for DEFINITY as an ultrasound enhancing agent in pediatric patients with suboptimal echocardiograms. Rigorous clinical trials affirm DEFINITY’s efficacy and safety in this population, marking a significant stride…
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What You Should Know:
– X-trodes, a pioneer in wireless monitoring solutions, has achieved a major milestone with the U.S. Food and Drug Administration (FDA) granting 510(k) clearance for its Smart Skin solution, marketed as…
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What You Should Know:
Proscia, a leading provider of digital and computational pathology solutions, has received 510(k) clearance from the United States (U.S.) Food and Drug Administration (FDA) for its Concentriq® AP-Dx*. The digital pathology solution…
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What You Should Know:
– Samsung’s Galaxy Watch has received De Novo authorization from the US Food and Drug Administration (FDA) for its sleep apnea detection feature.
– This marks a significant step forward in wearable…
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Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents…
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Doctors and researchers from the University of Maryland School of Medicine, the UMD Institute for Health Computing and the VA Maryland Healthcare System are concerned that large language models summarizing clinical data could meet…
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