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The FDA has granted 501(k) clearance to BodyPort for its cardiovascular monitor that tracks patients with fluid management related heart conditions such as kidney disease and heart failure. According to the CDC, over 6 million adults in the US suffer from heart failure, resulting in over 12 million clinical visits and approximately 1.2 million hospitalizations annually. 90% of these hospitalizations are said to be the result of hemodynamic changes causing fluid accumulation. Typically, weight gain is the standard for non-invasive detection of fluid changes. However, Bodyport has developed a scale to measure fluid changes alternatively. To use the device, individuals…

Northwestern University has recently published a study that details a new device which may present an alternative to opioids for pain relief. The study, reported June 30th, details a new device that is implanted near a patient’s nerves. The device cools down nerves and blocks pain signals from transmitting to the brain.  After an accident or medical procedure results in injury, patients are typically issued several forms of pain relief. These include local injections or various pain relief medications which dull the pain receptors. However, the large-scale provision of these pain relief medications has caused an opioid epidemic resulting in…

The Food and Drug Administration has awarded 501k clearance to Verily and iRhythm Technologies for the new cardiac arrhythmia feature on their Zio Watch. The approval comes as wearables continue to become an integral part of healthcare treatment. Wearables can be used to contact others, for navigation, and perhaps most importantly, monitor a user’s health. Google has recognized the potential wearables have to help individuals and encouraged their sister company Verily and iRhythm Technologies to design a wearable capable of competing in the wearables market.  The company created the Zio Watch. The new device works in collaboration with Zio ECG…

Medtronic has recently announced that their spine analyzing planning platform has received FDA 501k clearance. The healthcare technology global leader reported the news on July 14 2022. The UNiD Spine Analyzer v4.0 planning platform includes an artificial intelligence powered algorithm called the Degen Algorithm which helps surgeons to design and personalize procedures for individuals undergoing lower lumbar spine surgery and anticipates spinal compensatory processes 6 months following surgery. In addition, the planning platform will include advancements in predicting spinal alterations in both children and adults.  Degenerative spine disease is a common age-related condition that results in disabilities for individuals all…

The U.S. Food and Drug Administration has given 501k clearance to Apple for a new smart watch feature. The clearance comes as wearables continue to be integrated into healthcare provision. Today, wearables can help measure data related to temperature, blood pressure, blood oxygen, breathing rate, physical movement, and the electrical activity of several organs. Apple has utilized this technology to design a feature which is capable of detecting signs of atrial fibrillation (AFib) in its user.  The Food and Drug Administration approved the Apple Watch as a viable tool for detecting irregular heart rhythms in 2018. Although the Watch’s electrocardiogram…

The National Institute of Standards and Technology (NIST) has issued its updated healthcare cybersecurity and HIPAA Security Rule guidance to help aid health organizations in safeguarding their Protected Health Information.  The Health Insurance Portability and Accountability Act was introduced to establish national standards for the protection of electronic protected health information that is managed by HIPAA-covered entities. A significant component of the Act is the HIPAA Security Rule, which requires covered entities to implement the appropriate physical, technical, and administrative safeguards in order to ensure the confidentiality, integrity, and availability of the protected health information they maintain. Compliance with the…

The Department of Health and Human Services’ Health Sector Cybersecurity Coordinator (HC3) has issued an alert on july 21 about an increase in the number of web application attacks on the healthcare sector. In the alert, the HC3 outlines guidelines to help healthcare organizations to protect their health data against web application attacks. Web applications have become a significant proponent of the healthcare sector in recent years. The software has been utilized for patient portals, maintaining electronic medical record systems, CAD for dentists, remote consultation, predictive analysis, and inventory management. Web applications are accessed through a web browser such as…