MedTech Device News

Sedgwick researchers have discovered a substantial drop in the number of recalled medical device units, while cybersecurity and Software as a Medical Device (SaMD) concerns continue to grow. According to the 2023 U.S. Recall Index, recalled medical device units dropped by 27.2%, from 602.5 million in 2021 to 438.4 million in 2022. In contrast, the number of medical device recall events rose by 11.4% in 2022, from 837 in 2021 to 932. Sedgwick reports that mislabeling was the leading cause of recall activity in 2022, with 154 events (16.9%), dethroning Software, which had held the top position for five consecutive…

Recently, the U.S. Food and Drug Administration (FDA) has shared an update addressing reports of squamous cell carcinoma (SCC), a relatively rare cancer form, found in the scar tissue (capsule) developing around breast implants. This important update follows a safety communication in September 2022, which initially alerted the public to the presence of SCC and various lymphomas in the tissue around breast implants, raising concerns among patients and healthcare providers alike. Breast implants, not intended to be permanent fixtures, function as medical devices implanted beneath the breast tissue or chest muscle for the purpose of enlarging the breast size (augmentation)…

A groundbreaking study published on February 9, 2023 in PLOS Digital Health by Tiffany Kung, Victor Tseng, and colleagues at AnsibleHealth has revealed that ChatGPT, the large language model created by OpenAI, is capable of scoring at or near the passing threshold for the United States Medical Licensing Exam (USMLE). The research found that ChatGPT’s responses demonstrate a high level of coherence, internal consistency, and frequent insightful content, with scores hovering around 60 percent. This is a significant development in the field of artificial intelligence and healthcare, and has far-reaching implications for the future of medical education and practice. OpenAI’s…

Researchers have made a groundbreaking discovery in the field of brain blood clot clearance with the development of a new tool and technique utilizing vortex ultrasound. The revolutionary approach uses ultrasonic waves in the form of a “tornado” to effectively break down clots in the brain. In early stage tests, the method proved to be faster in eliminating clots in a simulated model of cerebral venous sinus thrombosis (CVST) compared to existing techniques. Cerebral venous sinus thrombosis (CVST) is a pathological condition in which blood clots form in the cerebral venous sinuses, leading to strokes in young individuals. According to…

A new study published in Frontiers in Global Women’s Health has unveiled a remarkable development in enhancing the safety of pregnancy. The low-cost sensing glove, priced at only $1, was created to support healthcare staff in identifying fetal position and the force applied to the fetal head during labor. These factors, which can contribute to obstructed labor and poor birth outcomes, can now be monitored in real-time thanks to the technology provided by the glove during vaginal examinations.  The development of the low-cost sensing glove was based on a simple surgical glove as the foundation. The researchers printed flexible pressure…

In response to the growing mental health crisis among teenagers, Oregon Health and Science University (OHSU) and Analog Devices, Inc (ADI) have partnered to develop a wearable smartwatch device to detect suicidality and depression. Among children and adolescents aged 10 to 17, suicide is the second-leading cause of death, with rates rising from 6.8 per 100,000 in 2007 to 10.7 per 100,000 in 2018. Furthermore, 18.8 percent of high school students in the US have reported thoughts related to suicide. The demand for mental healthcare often exceeds the number of mental health beds available, forcing patients to wait in the…

Global medical technology leader, Zimmer Biomet Holdings, Inc., has announced that their Persona OsseoTi Keel Tibia cementless knee replacement device has received U.S. Food and Drug Administration 510(k) clearance.  In recent years, cementless knees have revolutionized the orthopedic industry in the United States, forcing businesses without the necessary technology, like Smith & Nephew, to scramble to add the products to their portfolios. Zimmer has been expanding its cementless product line for many years. In 2018, the Persona Trabecular Metal Tibia received FDA certification, and now the company is adding a 3D-printed product to its line-up. The Persona OsseoTi Knee System…

According to new research published in npj Digital Medicine, researchers from John Hopkins Medicine have found that data from wearable activity trackers can be used to evaluate cardiovascular health status. Researchers claim that although the usage of wearable sensors has increased dramatically in recent years, their primary function is still to count daily steps. The purpose of this study was to demonstrate that wearable activity trackers can be used to collect clinically significant parameters other than daily step count. “The purpose of this study was to show that clinically relevant metrics beyond daily step count can be derived from these…

The National Football League (NFL) has announced the expansion of its collaboration with leading research universities to gather information from on-field head impacts using novel mouthguard sensors. This information will be used to guide injury prevention efforts at the professional and collegiate levels, including rule changes and the development of improved gear such as position-specific helmets. The University of Florida, The University of Georgia, The University of Pittsburgh, and Vanderbilt University are joining the program this year. The University of Alabama, University of North Carolina at Chapel Hill, University of Washington, and University of Wisconsin were the four institutions already…

A recent Microsoft-backed study conducted by the Ponemon Institute has found that while the usage of connected devices in hospitals can promote productivity, security, and positive patient outcomes, they have also significantly increased the surface for attacks, and many of these devices are either missing necessary security features or are not configured properly. According to the study, IoT/OT devices are among the least secure components of networks, according to 65 percent of organizations, and 50 percent of those same organizations indicate an increase in cyberattacks on IoT/OT devices. 88 percent of participants stated to have internet-connected IoT devices, while 51…

A recent study published in the Canadian Journal of Cardiology suggests that the results smartwatches offer may not always be reliable, despite the fact that using them to identify cardiac conditions like atrial fibrillation (AFib) opens up intriguing new options for heart care. Using the Apple Watch’s electrical heart sensor, the electrocardiogram (ECG) application monitor’s the user’s heartbeat. The program then examines the recorded data to identify abnormal heart rhythms. The study was conducted in order to evaluate the Apple Watch’s  ECG feature’s ability to reliably identify AFib in its users. The study consisted of 734 patients, approximately a fifth…

The National Science Foundation (NSF) has awarded $1.2 million to a multidisciplinary team headed by UC San Diego researchers to develop a unique approach for researching and informing the management of chronic lower back pain. A variety of techniques, such as wearable sensors and machine learning, will be used in the project to improve physical therapy assessment and treatment. According to the UC San Diego’s press release, up to 80 percent of people suffer low back pain at some point in their lives, and the yearly cost of treatment and lost pay as a result of disability in the United…

The United States Food and Drug Administration (FDA) has warned the healthcare sector of cybersecurity risks associated with the Medtronic MiniMed 600 Series Insulin Pump System. A malicious actor could exploit an issue in the pump system’s communication protocol which may lead to unauthorized access to the device. With access to the device, the actor can manipulate the amount of insulin provided to deliver too much or too little. An attack of this nature can result in a seizure, come, hyperglycemia, and death.   The MiniMed 600 series pump system is made up of wirelessly communicating components including the pump, continuous…

Medtronic has become the first company to receive the U.S. Food and Drug Administration’s (FDA) approval for their Onyx Frontier and Resolute Onyx drug-eluting stents used for bifurcation percutaneous coronary intervention. With FDA approval, Medtronic will be able to offer a wide range of medical training and technical assistance to physicians using percutaneous coronary interventions to treat patients with bifurcation lesions. Bifurcation lesions occur when plaque accumulates at the meeting point of two coronary arteries. As a result of the structural changes in the arteries and the difficulty in obtaining access to the side branches, the lesions are often regarded…

Researchers at Mount Sinai conducted a study to assess the physiological effects of the COVID-19 pandemic on healthcare workers, utilizing both wearable devices and a customized mobile health application. This study included 361 healthcare workers from seven different hospitals in the New York City health system. These participants completed weekly surveys to assess their perceived stress, emotional support, resilience, optimism, and quality of life. The wearable devices were used to measure heart rate variability, a marker of stress. This study highlights the importance of emotional support and resilience in helping healthcare workers cope with the pandemic. The research showed that…

The United States’ Federal Bureau of Investigation’ Cyber Division has released a private industry notification alerting healthcare organizations of the growing number of medical device vulnerabilities. According to the notification, cybercriminals may exploit these weaknesses to negatively affect a healthcare organization’s operational functions, patient safety, data confidentiality, and data integrity.  Medical device hardware frequently operates for 10 to 30 years. However, manufacturers determine the life cycle of the underlying software which can range from a few months to the device’s maximum life expectancy. Medical devices are particularly vulnerable to attacks as they frequently contain outdated software as manufacturers do not…

Medical device manufacturer Medtronic has reported two fatalities as a result of faults found in their EMG endotracheal tube. According to a recall notice posted by the United States Food and Drug Administration (FDA),  the company has received 15 complaints between the period of March 2020 to March 2022.  In April, Medtronic recalled its Medtronic’s NIM CONTACT Reinforced EMG Endotracheal Tube and NIM Standard Reinforced EMG Endotracheal Tube devices. The devices are used to provide an airway to patient ventilation and monitor EMG activity and the nerve integrity of the  thyroarytenoid muscle of the larynx. The recall was made by…

The United States Cybersecurity and Infrastructure Agency had issued a medical advisory to the healthcare sector reagrdign four vulnerabilities within the Sigma and Baxter Spectrum Infusion Pumps, a device typically used to provide medications and nutrition to patients. The vulnerabillties within the fusion pumps were identified by IoT researchers at Rapid 7, a well-known security solution provider. The issues were then reported to Baxter who are currently working with the security solution provider to resolve the vulnerabilities.  The versions of the device with vulnerabtilies include the Sigma Spectrum v6.x model 35700BAX, Sigma Spectrum v8.x model 35700BAX2, Baxter Spectrum IQ (v9.x)…

Abbott’s new spinal cord stimulation system has been approved by the U.S. Food and Drug Administration. In an press release on August 23, 2022, the medical technology manufacturer announced that their Proclaim Plus cord stimulation system will be available to provide physicians the opportunity to treat multi-site and evolving pain. Abbott is a global leader in healthcare that works to improve quality of life for people at all phases of life. The company works to provide life-changing technologies in various areas of healthcare including medical equipment, nutritionals, and generic medicines.  According to Abbot, over 50 million Americans suffer from chronic…

The U.S. Food and Administration has categorized Gentinge’s recall of over 11,000 ventilators as a class I event. After discovering the ventilators may produce a combination of technical alarms that may result in a loss of communication and cut of ventilation. This can result in dire consequences as the patient’s breathing pattern may be impeded and therefore will receive too little oxygen to enter the blood and cause brain damage and circulatory failure.   Getinge has recalled four devices, including the Servo-u mechanical ventilator and the Servo-n product intended for use with newborns. After discovering the faults in over 11,089 ventilators…

A wireless wearable skin sensor that can measure activity levels, blood pressure, heart rate, and glucose levels without a bluetooth chip has been developed by Massachusetts Institute of Technology researchers. The usage of wearable technology in healthcare is rapidly increasing. The technology is used to treat a variety of medical conditions, including cardiac issues. Researchers from MIT stated that Bluetooth chips used in products are sizable and can cause problems, despite the fact that they are frequently effective. In order to avoid the need for bulky chip implants, MIT engineers developed a wireless wearable skin sensor that can gather several…

A team of MIT engineers and collaborators has designed an implantable device that prevents the buildup of scar tissue around medical implants. Implantable devices can be used to treat diabetes without insulin injections or cannula insertions by releasing insulin into the system. However, implantable devices can often trigger a foreign body response, a formation of a thick layer of scar tissue that prevents insulin release within weeks or months. As a result, the majority of patients with type 1 diabetes prefer to receive insulin through daily injections. These can be provided through wearable insulin pumps or insulin patches.  The researchers…

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…

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…

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…

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…

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….

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,…

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…

The Health and Human 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,…

A new study published in the journal Cell Reports Medicine discovered that a smartwatch can monitor the progression of COVID-19 symptoms. For the study, researchers at the University of Michigan analyzed the impacts of COVID-19 using six factors derived from heart rate data. After following Michigan students and medical interns across the country, the researchers found new indicators embedded in heart rate which can help identify those infected with the virus and how sick they became. For example, the researchers discovered  that those with COVID exhibited an increase in heart rate per step following the beginning of symptoms and that…

Researchers at Scripps Research have recently published a new digital health study that demonstrates how data from wearable sensors, such as smartwatches and activity bands, can monitor a person’s physiological reaction to the COVID-19 immunization. The study, which was published in the npj Digital Medicine journal, examined sensor data on heart rate, activity, and sleep from over 5,600 participants. The information was obtained from a larger initiative known as DETECT (Digital Engagement and Tracking for Early Control and Treatment), which was started in March 2020. The initiative enables users to manually enter symptoms, test results, and immunization status in addition…

According to a recent study conducted by Imperial College London, measuring blood oxygen levels at home is a safe approach for individuals with COVID-19 to identify warning indicators that their health may be deteriorating and that they may need urgent and inpatient hospitalization. Pulse oximeters are medical devices used to measure a patient’s blood oxygen saturation. Prior studies have demonstrated that a drop in an individual’s blood oxygen levels is a critical indicator of a COVID-19 patient’s health worsening and may indicate the need for closer monitoring and immediate treatment.  The study, which was published in the journal Lancet Digital…

In an effort to tackle the opioid epidemic, researchers from the University of Massachusetts Amherst, Syracuse University and SUNY Upstate Medical University have come together to create a wireless sensor designed to help prevent opioid relapses and overdoses. The National Institute on Drug Abuse has reported that in 2019, approximately 50,000 people in the US passed away due to opioid-linked overdoses. Moreover, federal data suggests that between 21 and 29 percent of those prescribed opioids for chronic pain misuse them. The research team, led by Tauhidur Rahman, PhD, an assistant professor in the College of Information and Computer Sciences at…