Seventh Sense Biosystems, a company based outside of Boston, MA, won FDA clearance for its TAP device to be used by laypersons to collect blood. Moreover, the device is now cleared to be used at home by individuals for “wellness testing,” according to the company. “We’re very excited about this clearance since it represents (Read more...)
Tag: Medicine
Tandem’s t:slim X2 Insulin Pump Now with Control-IQ Auto Dosing
The FDA has just cleared the first intelligent insulin pump that can automatically administer correction boluses in addition to regulating insulin to prevent high and low blood sugar levels. Tandem Diabetes’ updated t:slim X2 insulin pump works with Dexcom’s G6 continuous glucometer and features Tandem’s new Control-IQ technology (Read more...)
SOZO System FDA Cleared for Protein Calorie Malnutrition Assessment
ImpediMed, a company based in Carlsbad, California, won clearance from the FDA for its SOZO device to assess protein calorie malnutrition. The condition can be common in cancer patients, so recognizing it before obvious symptoms, such as muscle wasting, appear is very important. Moreover, quite a few patients who don’t have cancer are malnour (Read more...)
Nihon Kohden’s New Patient Monitor for Outpatient Clinics
Nihon Kohden’s U.S. division, itself based in Tokyo, Japan, is launching a new vital signs monitor specifically designed to extend monitoring capabilities to outpatient facilities and to patient beds that typically wouldn’t have continuous vital signs monitors. The device lets clinicians quickly take readings on blood oxygenation, blood (Read more...)
Beta Bionics iLet Bionic Pancreas System Gets FDA Breakthrough Designation
Beta Bionics, a firm based in Boston, MA, won Breakthrough Device designation from the FDA for its iLet Bionic Pancreas System, a wearable designed to automatically control blood-sugar levels. Unlike traditional insulin pumps, the iLet doesn’t need any input from the patient about their dietary intake, insulin delivery rates, nor are bolus do (Read more...)
Aptar’s Nasal Unidose Device Helps Stop Epileptic Seizures
AptarGroup, a company based outside of Chicago, Illinois, has announced that the FDA recently approved a medication (NAYZILAM (midazolam)) for treatment of acute repetitive epileptic seizures and that the company’s Unidose Liquid System was chosen as the delivery mechanism for this rescue drug. The Unidose Liquid System doesn’t require (Read more...)
Exclusive with CELLINK Co-Founders Erik Gatenholm and Dr. Héctor Martínez
CELLINK is a 3D bioprinting company based in Gothenburg, Sweden, and was one of the first companies in the world to offer 3D printable bioink, which is used to print human organs and tissues. In just four years of existence, the company has been able to commercialize products used in more than 700 labs and […]
Interview with Medtronic’s Mark Pacyna on Approval of IN.PACT AV DCB for Failing AV Fistulae
End-stage renal disease (ESRD) patients experiencing kidney failure typically require hemodialysis in order to artificially remove fluid and waste from blood and maintain appropriate electrolyte concentrations. For many patients on hemodialysis, an arteriovenous (AV) fistula is created to link an artery to a vein. Veins are too fragile for frequent (Read more...)
Liver Chip Avoids Animal Testing, Makes Drug Research Easier, Faster
Low liver toxicity is a major hurdle that drug candidates have to demonstrate before they are used as therapeutic medications. This testing is usually performed using animals, including rodents and dogs, with livers that aren’t quite like ours. Animal studies are useful, but they often result in misleading information, which may not be realiz (Read more...)
Samsung Unveils New RS85 Prestige Ultrasound System
At the RSNA conference in Chicago, Samsung unveiled a new high-end ultrasound, the RS85 Prestige. Based on the RS85, the system comes with a new imaging architecture as well as a set of features designed to expand the system’s capabilities and improve diagnostic accuracy. So-called “Crystal Architecture” within the RS85 Prestige r (Read more...)
AI Tool to Predict Checkpoint Therapy’s Effectiveness
Researchers from Case Western Reserve University have developed a new computational tool to predict, based on CT imaging, whether lung cancer patients will benefit from immune-checkpoint inhibitor cancer therapy. This is an exciting development for patients suffering from lung cancer, and may one day help inform medical decisions. Currently, there (Read more...)
Europe Clears RejuvenAir, a New Therapy for COPD with Chronic Bronchitis
Chronic bronchitis can be a difficult disease to live with, but when it’s coupled with COPD it can be truly debilitating. There are medications available that help to reduce mucus production and coughing, but these don’t really help the condition itself. CSA Medical, a Boston-based company, just won European regulatory approval to intro (Read more...)
DNA Circuits to Identify Cancer Cells
Researchers from Duke University have developed a new DNA-based tool to identify cancer cells. Their system is a DNA circuit. DNA binding to specific cell markers produces a signal if and only if two specific proteins are present, helping to improve specificity and reduce false positives in cancer cell detection. The researchers also hope that [&he (Read more...)
Wearable Sweat Sensor to Measure Gout-Causing Compounds
Researchers from Caltech, Peking University in China, Santa Clara University, and University of California, Los Angeles have developed a new wearable sensor that can detect gout-causing compounds in sweat. The device relies on novel laser-engraved chemical sensors to detect gout-causing compounds uric acid and tyrosine at concentrations much lower (Read more...)
Eko Releases New CORE Digital Stethoscope Offerings
Eko Devices just announced it’s releasing the second generation of its popular CORE digital stethoscope technology. The new Eko CORE comes either as an all-in-one digital stethoscope or as an attachment for most existing stethoscopes. This gives nurses and physicians the option to go with Eko’s own stethoscope or stay with one of their (Read more...)
Canon’s New High-End PET/CT Scanner Unveiled
Canon Medical is releasing a new high-end digital PET/CT scanner at the upcoming RSNA conference in Chicago. The Cartesion Prime Digital PET/CT combines Canon’s Aquilion Prime SP CT scanner and the SiPM (silicon photomultiplier) PET detector, providing high resolution imaging and easy operator control, according to the company. So far, it is (Read more...)
IN.PACT AV Drug Coated Balloon for Dialysis Patients to Heal AV Fistulaes
Medtronic has won FDA approval to introduce its IN.PACT AV drug-coated balloon as a treatment option for failing arteriovenous (AV) fistulae. People with non-functional kidneys who undergo dialysis receive AV fistulae, which link an artery to a vein. Veins tend to be too fragile for regular access, but arteries are too deep. Creating an AV [&hellip (Read more...)
Protective Membrane for Pacemakers to Make Replacement Surgeries Easier
Researchers at ETH Zurich have developed a cellulose membrane to cover and protect implantable devices, such as pacemakers. The material can reduce fibrotic build up and make subsequent surgical removal of implants much easier. So far, the pouch-like device has been tested successfully in pigs, and the researchers hope to apply for clinical trials (Read more...)
Siemens Healthineers Unveil SOMATOM X.cite Premium CT Scanner
Siemens Healthineers won FDA clearance and is releasing its brand new SOMATOM X.cite premium single-source CT scanner. The device, along with a high-end X-ray tube and other enhancements, features the company’s new myExam Companion technology that can intelligently adapt each scan to optimize a number of variables. The system asks a number of (Read more...)
Self-Propelled Enzyme-Coated Liposomes for Drug Delivery
Researchers at Penn State have developed self-propelled liposomes that can migrate towards or away from chemical signals, paving the way for self-directed drug delivery vehicles that can actively target a specific area in the body. The technology may help to enhance efficacy and reduce side-effects of drugs in a variety of applications. Because of (Read more...)