![]() customers with an innovative system that brings greater lab workflow efficiency. VITEK ® MS PRIME, manufactured by bioMérieux is a result of our constant commitment to support laboratories with tools that provide increased Antimicrobial Stewardship (AMS) efficiency and more effective patient therapy.īrian Armstrong, Senior Vice President, Clinical Operations, North America emphasized: “ With VITEK ® MS PRIME, we provide our U.S. With time-saving innovations to deliver faster identification results, VITEK ® MS PRIME is a compact benchtop system designed to increase laboratory productivity for greater impact to patient care. ![]() This next generation system for routine microbial identification in minutes is now commercially available in countries that recognize CE-marking and in the United States. However, as Bloomberg reported in April, the technology isn't expected to be ready until 2024, at the earliest.BioMérieux, a world leader in the field of in vitro diagnostics, announces that VITEK® MS PRIME, its new MALDI-TOF mass spectrometry identification system, has received 510(k) clearance from the U.S. ![]() Though ECG tracking has been cleared by the FDA, blood pressure monitoring isn't available in the U.S.Īpple is also interested in blood pressure monitoring for its Watch. Meanwhile, Samsung has incorporated blood pressure monitoring into its Galaxy smartwatches in countries where it has regulatory approval. Omron Healthcare first received FDA clearance for its HeartGuide wearable blood pressure monitor in 2018. yet, Aktiia announced in January it would be conducting a study with Brigham and Women's Hospital in Boston. Though it isn't available commercially in the U.S. #Fda 510k database seriesThe Swiss startup landed $17.5 million in Series A funding in November. We are focused on bringing this to millions of users across the channels of our customer-base."Īnother company behind a watch-like blood pressure device is Aktiia, which announced it had received a European CE mark in early 2021. "With the same ease as wearing a watch, the LiveOne device will change how hypertension and cardiovascular disease are managed and treated by offering people a thorough understanding of how their lifestyle, behavior and medication impact their blood pressure. "The LiveOne device is intended to combat the worldwide epidemic of hypertension by offering patients and providers meaningful, deeply personalized health information so action can be taken in real-time," Kelly Benning, vice president of LiveMetric, said in a statement. The Luxembourg-based company said the LiveOne monitoring service will soon be available through health systems, insurers and self-insured employers for people with hypertension or cardiovascular diseases. ![]() According to the FDA's 510(k) database, LiveOne is intended to be used in clinical settings for patients 27 years and older with a palpable radial pulse. The waveform is then analyzed by an algorithm to determine systolic and diastolic blood pressure and pulse rate. The cuffless device uses a sensor array placed over the radial artery to produce a pressure waveform. LiveMetric announced it has received FDA 510(k) clearance for its watch-like blood pressure monitor, LiveOne. ![]()
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