PARI Pharma, a German manufacturer of aerosol delivery products, won FDA approval of its LAMIRA nebulizer along with Insmed‘s ARIKAYCE (amikacin liposome inhalation suspension) drug for treating lung infections caused by the mycobacterium avium complex (MAC), a group of bacteria that are difficult to treat in many patients. The approval of the drug is the first […]
Tag: Pediatrics
Abbott’s New FreeStyle Libre 2 Continuous Glucometer with Level Alarms Cleared in EU
Abbott won the European CE Mark for its FreeStyle Libre 2 continuous glucose monitor that features low and high glucose level alarms, letting patients know in real-time that they’re falling outside of their normal range. The system doesn’t require regular and painful finger pricks, instead relying on an upper arm sensor that regularly measures glucose […]
Philips Unveils Augmented Infant Resuscitator for Safe Rescue of Asphyxiated Newborns
A collaboration between Philips, and researchers at Massachusetts General Hospital, Mbarara University of Science and Technology in Uganda, and MIT, has developed a device that helps to safely resuscitate asphyxiated newborns. The Philips Augmented Infant Resuscitator (AIR) attaches to nearly all manual bag-valve-mask resuscitators to measure and help regulate the aiflow delivered to the baby. Currently, all too […]
First Blood Pressure Monitor with Cellular Connectivity Now Available in U.S.
Livongo, a Silicon Valley firm, is releasing in the U.S. its cellular-based blood pressure monitor, along with a smartphone app and accompanying online platform for managing and sharing the readings. The blood pressure unit uploads its measurements to the Livongo cloud platform, without having to connect the device to a WiFi network, what the company […]
Philips Trilogy Evo Portable Ventilator Platform Makes Transitions Easy
Being on a ventilator can be a frightening experience for many patients, and switching between different ventilators for transport, or when going home, can be emotionally challenging as well. To make transitions such as these easier for patients and clinicians, and to provide users the confidence that they’re receiving consistent and closely monitored care, Philips […]
Paper Test for Monitoring Phenylalanine and Other Metabolites in Blood
People with congenital phenylketonuria, a condition in which the amino acid phenylalanine is overproduced, have to undergo regular blood testing. This is important in part because maintaining a proper diet can reduce phenylalanine levels, so gauging the effectiveness of one’s diet can help control the condition. Currently, though, blood samples have to be sent out to […]
Flexible Stick-On Ultrasound Patch Measures Central Blood Pressure
Scientists at the University of California San Diego created a flexible ultrasonic patch that can measure the blood pressure in major vessels such as the jugular vein and carotid artery. The technology has already shown, in a proof-of-concept study, that it may be made as accurate as invasive means to measure the central blood pressure. […]
Veta Smart Case for Epinephrine Auto Injectors Now Available
Aterica, a Canadian company, is releasing its Veta smart case for epinephrine auto injectors (think EPIPEN). The device works in conjunction with a paired app to track usage of an auto-injector, as well as to monitor its location, its temperature, and expiration dates. The Veta is used in place of the standard cases that auto […]
Masimo’s Tiny Breathing Sensor Cleared for Tiny Patients in U.S.
Masimo won FDA clearance for its RAS-45 acoustic respiration sensor, used with the rainbow Acoustic Monitoring (RAM), to be used on infants and neonates. Previously, only patients over 22 pounds (10 kilograms) were eligible for RAM sensors, but the new clearance provides an easy way to monitor the rate of breathing in the tiniest patients. This […]
ivWatch Vein Puncture Monitor Cleared in Europe
ivWatch just announced winning the European CE Mark for its ivWatch Model 400 device, the only continuous monitor for timely detection of intravenous (IV) infiltrations and extravasations. IV delivered medication and fluids can accidentally leak outside of the vein into surrounding tissue, creating serious complications for patients. The device works by shining visible and near-infrared light […]
VistaTablet for Monitoring Patients’ Eight Vital Signs from Anywhere
VitalConnect, a Silicon Valley firm, is releasing its brand new patient-monitoring handheld interface for its VitalPatch vitals monitor. The VistaTablet and and VitalPatch are both part of the company’s Vista Solution, which allows clinicians to keep an eye on their patients ECG, heart rate, heart rate variability, respiratory rate, skin temperature, body posture, and activity […]
Hailie Inhaler Monitoring System Now Available Direct to Consumers
Adherium, a Silicon Valley firm, is releasing its Hailie system for inhaler monitoring in the United States. The company received FDA clearance to sell the product over the counter, allowing patients to work toward improved compliance with regards to their medications. The system includes a sensor that is attached to an inhaler and a smartphone […]
Shift Labs Announces Partnership with Option Care Enterprises for National Use of DripAssist
DripAssist by Shift Labs is an infusion rate monitor that offers a significant improvement in portability, efficiency, durability and ease of use over traditional infusion monitors. The last time Medgadget reported on Shift Labs, the company had just received their CE mark for DripAssist. The device is also FDA approved. Now, Shift Labs is announcing a […]
Ocular Abnormalities in Congenital Zika Syndrome
This report details ocular abnormalities associated with Zika infection, underscoring the need for an early eye-screening exam for infants in which congenital Zika syndrome is suspected. Journal of Medical Case Reports
Abbott’s FreeStyle Libre 14 Day Flash Glucose Monitor Approved in U.S.
Abbott won FDA approval for its FreeStyle Libre 14 day Flash Glucose Monitoring system. The stick-on glucometer can be worn continuously for two whole weeks, through sweating and showers, while accurately reading plasma glucose readings. The device is stuck to the back of the upper arm and a separate display device, which looks like a smartphone, is […]
Clinical Grade Urinalysis at Home with Your Smartphone
Smartphones have become surprisingly useful in medicine, but they still remain mostly as assistants to the core process of medicine. They make it easy for clinicians to communicate, absorb information, take notes, and do so many other things. They’re still rarely used for diagnostics, but that’s changing too. Healthy.io, a company out of Tel Aviv, […]
Accu-Chek Solo Tube-Free Insulin Micropump Cleared in Europe
Roche will soon release in Europe its tube-free Accu-Chek Solo insulin micropump following the CE marking of the device. The micropump comes with a smartphone-like wireless remote control that features glucose monitoring and provides advice on how much insulin to administer. Moreover, the remote control can be used to select how much insulin to inject […]
First Fingerstick Glucometer Cleared by FDA for Critically Ill Patients
Nova Biomedical, a firm out of Waltham, MA, won the first FDA clearance for a fingerstick glucose meter that can be used with critically ill patients. The clearance for the StatStrip Glucose Hospital Meter System allows arterial, venous, or capillary samples to be used from all patient types, effectively making it the only universal fingerstick glucometer […]
InPen Cleared in Europe to Make Insulin Injections Easier
Companion Medical, a company based in San Diego, landed the European CE Mark of approval for its InPen insulin management system. The InPen, which is already available in the United States, works like a common insulin pen, but also with the ability to send its usage data to paired smartphone. The data is used to […]
Convenient Allergy Testing: Interview with Dr. Dua of Heal and Rebecca Rosenberger of Thermo Fisher Scientific
Heal, a California-based company, offers a doctor house call service and sends doctors to patients’ homes, or even work offices, for $99 or insurance copay. The service is currently available in Southern California, the Inland Empire, the San Francisco Bay Area, Silicon Valley, Sacramento, Washington D.C. and Northern Virginia, with plans to expand to more […]