Study Finds Sepsis Detection Tool Reduces Deaths

Bayesian Health, a machine learning startup has found in collaboration with Johns Hopkins University that a sepsis early detection tool has reduced sepsis associated deaths by approximately 18%. Sepsis is identified as a life-threatening reaction to an infection. It occurs when the immune system overreacts to an infection and creates inflammation. Blood clots and leaking blood vessels occur, and can cause damage to the body’s tissue and organs. Sepsis is extremely common, affecting approximately 1.7 million adults annually. However, despite its prevalence, over 250,000 instances resulted in death. Sepsis is often simple to overlook because its symptoms such as fever…

Smiths Medical Recalls Infusion Pumps After Patient Death

The U.S. Food and Drug Administration has announced that Smiths Medical, a medical device manufacturer, has sent an Urgent Medical Device Correction letter to inform its customers about potential risks associated with their Syringe Infusion Pumps.The letter notified users that the Smiths Medical Medfusion 4000 and 3500 Syringe Infusion Pumps suffer from 8 potential software issues. The devices are used by healthcare providers to deliver blood or blood products, drugs, antibiotics, lipids, enteral feedings and other therapeutic fluids through infusion tubing into a patient’s vein or through other routes of administration. The devices are typically used in neonatal and pediatric…

510(k) Clearance Granted To ResApp Sleep Apnea Detection App

The US Food and Drug Administration has granted clearance to ResApp Health’s 510(k) app. The SleepCheckRx app screens users for moderate to severe sleep apnea by listening to recordings of their breathing and snoring. The regulatory clearance will only apply to the iPhone version. However, ResApp has stated that they are committed to developing an android version.  In the U.S. alone, approximately 20 million American adults live with sleep apnea. Despite the high number, the majority are unaware of their condition. The new app will help provide physicians with the opportunity to evaluate their patients effectively. To acquire access to…

FDA Grants Breakthrough Device Designation To Ventricular Restoration Device

The FDA has awarded Breakthrough Device Designation to Ancora Heart’s Accucinch ventricular restoration system. The device was constructed to help reduce ejection fraction from patients with symptomatic heart failure. It achieves this by restoring the makeup and activity of an enlarged left ventricle. In turn, heart failure symptoms are reduced and the quality of life of patients is improved greatly.  The FDA Breakthrough Devices Designation program was introduced to help patients receive timely access to treatment innovations without compromising their safety. The program helps expedite the development of novel medical devices that have the potential to give more effective treatment…

FDA Grants Breakthrough Device Tag To Abbott’s DBS System

On July 12, 2022, the FDA awarded Breakthrough Device Designation to Abbott’s deep brain stimulation (DBS) device developed to care for treatment resistant depression (TRD). The Breakthrough Devices Designation program was developed to help patients gain timely access to innovations without putting the patients at risk. The program has helped expedite several innovative technologies that help provide a better quality of life to patients with severe illnesses and diseases. Typically, Abbott’s DBS device is used to treat movement symptoms of patients’ neurological disorders such as Parkinson’s disease and essential tremor. However, recent evidence indicates that the device may be used…

Study Finds Racial Bias In Faulty Oximeter Readings

The pulse oximeter is a frequently used device to measure oxygen saturation of the blood and the pulse rate. However, the pulse oximeter has been found to overestimate actual oxygenation.The inaccurate readings are typically found in patients identified as a racial and ethnic minority. A recent study published in the JAMA Network, has attempted to determine how inaccurate readings affect patient care.  The study was conducted using a dataset of approximately 3,000 patients who were admitted to the ICU. The oxygenation levels and nasal cannula flow rates were examined for up to 5 days from the date of ICU admission….

Study Finds Wearables Are More Frequent In Cardiac Health Patient Visits

As technology continues to evolve, so too does the individual’s ability to monitor their health. Wearable health technology is rapidly becoming a significant component of the healthcare industry as sensors and artificial intelligence continue to improve. As wearable technology is a relatively new area of health care, there is little information regarding its future use and its place in healthcare provision. Researchers from Massachusetts General Hospital have conducted a study attempting to address the lack of information with wearables and their relationship to cardiac health.  Although wearables can help measure data related to temperature, blood pressure, blood oxygen, breathing rate,…

Wireless Osseosurface Electronic Sensors to Monitor Bone Health

The musculoskeletal system is an area of particular complexity within the study of anatomy. Currently scientists do not understand precisely how a bone heals. Responses can change depending on the individual. As a result, the provision of personalized treatment is challenging. A better understanding of how a bone is healing and responding to treatment enables physicians to tailor treatment according to their patient and will avoid any unintended adverse effects.  Significant advances are taking place as scientists continue to develop bioelectronic interfaces including soft and ultrathin sensors. These tools provide scientists the opportunity to explore and examine unexplored areas of…

New HHS Guidelines for Telehealth Providers

The Human and Health Services Department’s Office for Civil Rights has issued new guidelines regarding the use of telehealth technologies for covered health care providers and health plans. Due to the nature of the COVID-19 pandemic, in-person visits from patients to physicians were restricted to only the extremely necessary in order to stop the spread of COVID-19. Because of this, the use of telehealth technologies to deliver health care increased greatly.  While telehealth can expand the access to health care, certain groups of people may face difficulty with accessing telehealth technologies. Populations with limited English proficiency, disabilities, restricted internet access, restricted…

Technologies Supporting Telehealth are Placing Healthcare Data at Risk

A new Kaspersky report shows that the substantial growth in telehealth has put healthcare information in danger. Vulnerabilities were discovered in the systems that are used in telemedicine, a lot of which have yet to be resolved. Substantial Growth in Using Telehealth The COVID-19 pandemic contributed to a growth in virtual appointments, with healthcare companies expanding telehealthcare access to help control infections and reduce healthcare costs. Virtual appointments are done through the phone, video-conferencing applications, and other platforms. A number of new systems and products like wearable devices for measuring vital signs, implanted sensors, and web services are likewise being…