TeleMed Texts: Smartphone App Detects Newborn Jaundice in Minutes
Physicians and engineers at the University of Washington developed a smartphone application, BiliCam, to help parents and physicians detect jaundice in newborns within a matter of minutes. Jaundice is a condition that is prevalent in most newborns, due to an excess amount of the chemical, bilirubin, in their blood. BiliCam works with a smartphone’s camera, flash and a color calibration card that adjusts and accounts for varied skin tones and lighting conditions.
To use the app, a parent or physician places the card on the baby’s belly and takes a picture. The picture is then is sent securely to the cloud where it can be analyzed by machine-learning algorithms, which produce results that are instantly sent to the parent’s phone. The new app offers an affordable, non-invasive way to check bilirubin counts in newborns. Patents have been filed on the technology, and the researchers hope to have FDA approval within a couple of years.
Med Device: 12-Year-Old Receives First 3D Printed Vertebra Implant
A 12-year-old boy from China received the first 3D printed vertebra implant at Peking University Third Hospital (PUTH). The five-hour-long, cutting-edge procedure was performed after a soccer injury revealed a malignant tumor on the boy’s spinal cord. Doctors had to remove the second vertebra to prevent the cancer from spreading, requiring the need for an implant.
Unlike traditional pre-fabricated devices, doctors used a 3D printed implant made of titanium powder. It is designed to match the structure of the existing bone, which allows for a more natural fit between the first and second vertebrae, a feature of the technology that eliminates the need for cement or screw anchors. The implant is also covered with small holes that allow the bone to grow naturally into it, making it a permanent structure. The boy was fitted with a halo that will immobilize his spine while recovering, which should take anywhere from three to five months. Doctors expect a promising recovery.
Trend Setting: AllazoHealth Addresses Current Trends in Medication Adherence Programs
Researchers at AllazoHealth released a two-part survey analyzing the current medication adherence intervention programs of Managed Care Organizations (MCO). The basis for releasing this information is to improve current medical adherence programs, which critically affect non-adherent patients. The implementation of the medication adherence programs by MCOs are designed to improve the outcomes of those patients who incur substantially higher medical costs and tend to have a lower quality of life.
The two-part survey was conducted in spring of 2014, with 30 participating MCOs. It focused on questions about existing medication adherence programs and interventions, intervention efficacy and the selective process for patient intervention. Some highlights from the survey: 90% of MCOs use telephone outreach for patient interventions to improve adherence, 77% use direct mail and only 50% have face-to-face visits with patients. 93% of MCOs have programs for patients with diabetes and hypertension—the most common disease-states targeted.
Therapeutic Talk: U.S. Heart Disease and Strokes Drop
According to researchers at the Yale School of Medicine, during the last decade, the number of hospitalizations and deaths associated with heart disease and stroke have dropped more significantly than any other conditions in the United States. Dr. Harlan Krumholz, Yale School of Medicine Researcher, Director of the Center of Evaluation at Yale-New Haven Hospital and volunteer at the American Heart Association, attributes the drop to the increased awareness placed on heart-healthy lifestyles and behaviors. Krumholz also connects the drop to the increased use of evidence-based treatment and medications. This data was collected by Krumholtz and a team of researchers who examined data from 1999 to 2011, and is based on the experiences of nearly 34 million Medicare fee-for-service patients.
Discoveries/Innovations: Muscle-Powered Bio-Bots Walk On Command
Engineers at the University of Illinois invented a class of walking “bio-bots” that are powered by muscle cells and controlled by electrical pulses, which give researchers extraordinary command over their function. The bio-bots measure less than a centimeter in size and are made of flexible 3D printed hydrogels and living cells, resembling the naturally occurring muscle-tendon complex.
The 3D printed hydrogel has a backbone that provides the bio-bot a solid structure and the flexibility to bend like a joint. The bio-bots are powered by skeletal muscle cells that are triggered by electrical pulses. Through this design, researchers can easily control the bio-bots, which points the way forward for possible new design principles and customization. In the future, researchers will work on integrating neurons into the bio-bots in order to allow for controlled multi-directional motion. Where this will lead at this point is uncertain—but it is exciting.
FDA Update
Final Cybersecurity Guidance
A new guidance document, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, informs medical device manufacturers what must be submitted to show how they plan to migrate data security risks and protect their devices from hackers. Go to http://1.usa.gov/1udqVbc for the full guidance.
FDA Approvals
Vital Connect’s HealthPatch MD, a small, wireless biosensor patch that connects to a smartphone and is worn on the chest to track biometric measurements and vital signs for physician knowledge, received FDA clearance to function as a single-lead ECG. The device serves as a heart rate monitor, pedometer, thermometer and fall detector.
After receiving FDA approval in August 2014 for the once-daily HIV treatment, Triumeg, made by ViiV Healthcare, the joint venture of GSK, Pfizer and Shionogi, the drug also received the approval of EU regulators. Triumeg is indicated for ages 12 and above.
An FDA advisory panel recommended backing the approval of Novo Nordisk’s not yet branded, Saxenda (liraglutide) for the treatment of obesity. While Saxenda is only a proposed brand name, liraglutide is approved to treat type 2 diabetes under the brand name Victoza.
FDA Plans To Include Minorities in Clinical Trials
The FDA developed a plan to increase the representation of women and minorities in clinical trials. It is designed to help improve data collection and subgroup data analysis. The plan will enable researchers to gather more comprehensive data demonstrating the different effects of drugs and medical devices on these groups.
