Access Vascular, based in Bedford, Massachusetts, won FDA clearance for the latest version of its HydroPICC anti-thrombogenic central line catheter. As with the original, which was cleared two years ago, the new device features Access’s unique “bulk-hydrophilic” material that prevents clogging by being rich in water while carrying a neutral surface charge. Proteins and other […]
Author: Medgadged
FDA Clears First Pulse Oximeter to Measure Breathing Rate
Masimo just received the first FDA clearance for a fingertip pulse oximeter that can measure respiration rate. The MightySat Rx spot-check pulse oximeter includes a technology known as Respiration Rate from the Pleth (RRP) that makes it unnecessary to perform manual counts or use chest electrodes to measure respiration rate. The device can be used […]
Notion Brain Computing Platform: Interview with AJ Keller, CEO of Neurosity
Neurosity, a neurotech company based in New York, has developed the Notion brain computing platform. The system has a huge range of potential medical applications, including monitoring a patient’s mental health, to diagnosing concussions, to allowing paralyzed patients to control electric wheelchairs. The headset can do this because it incorporates sensors that detect brain activity […]
Companion Medical Receives FDA Clearance for InPen Insulin Bolus Calculator
Companion Medical announced that it received FDA clearance for its InPen bolus calculator for fixed dosing and meal estimation. Only 42% of people living with Type 1 diabetes count carbohydrates to determine their mealtime insulin dose, according to the company. Incorrect carb counting and insulin dosages often result in hypo- and hyperglycemia. The bolus calculator […]
Trammpolin, A Meniscus Prosthesis to Improve Knee Surgeries: Interview with CEO Jan Hunik
Meniscus tears are a fairly common knee injury. Treatment typically involves complete or partial removal of the damaged meniscus. Without shock-absorbing role of the meniscus, however, patients are at risk for accelerated wear of the knee joint and osteoarthritis. Currently, patients have to wait for many years until they are eligible for a total knee […]
VistaScan Ultrasound Probes for Your Smartphone Cleared by FDA
Emagine Solutions Technology, a startup based in Tucson, Arizona, won FDA clearance for its VistaScan mobile ultrasound system. The product includes ultrasound probes that can interface with a clinician’s own smartphone or tablet, and the company’s app is used to display and manipulate live images produced by the probes. The company developed special software that […]
Device Prints Scaffolds Inside Wounds to Replace Lost Tissue
3D printing of artificial scaffolds intended to replace injured tissues has become a ballyhooed technology that’s yet to prove itself in clinical practice. One issue that complicates things is that the scaffolds have to match the volume that they’ll be replacing, in both shape and the direction in which cells will have to grow. To […]
Point-of-Care HIV Diagnostics for Low Resource Regions: Interview with Jesse Lehga, VP at Diagnostics for the Real World
DRW (Diagnostics for the Real World), a company with headquarters in San Jose, California, and Cambridge, United Kingdom, has developed the SAMBA II, a point-of-care diagnostic device for the detection of infectious diseases, including HIV and HCV, for use in low-resource and/or remote regions. The system employs nucleic acid amplification to detect viral RNA or […]
FUJIFILM’s AI Colonic Polyp Detector Cleared in Europe
FUJIFILM is introducing a new technology that is capable of automatically detecting suspected polyps in real-time during colonoscopy exams. Called CAD EYE, the technology consists of hardware and software components that are compatible with the company’s ELUXEO 7000 endoscopy system. CAD EYE relies on FUJIFILM’s REiLI, an AI platform developed for medical applications. It can […]
Adjustable Heart Valves Grow with Kids Hearts
A variety of congenital cardiac abnormalities require the placement of prosthetic heart valves in very young children. As the hearts grow, the valves have to be replaced through repeated surgeries. A team of researchers from Harvard and Boston Children’s Hospital have now developed an artificial valve that can be expanded, via a minimally invasive transcatheter […]
Hybrid Infrared-Optical Microscope for Pathology Studies
When imaging tissues microscopically, pathology labs have to stain the samples to see the cellular shapes and structures within. This is not trivial and requires expertise, time, and related costs. Infrared light has the capability to help visualize biomedical samples without staining, but the wavelengths of such light make it incompatible with optical microscopes and […]
First Noninvasive Cortisol Detector to Monitor Stress, Mental Conditions
Stress related to our mental well-being, including that associated with depression, anxiety, and PTSD, is difficult to measure in practice. Levels of cortisol, a steroid hormone, are closely linked to changes in one’s mental state and blood tests are available to measure cortisol. But a blood test can raise a person’s stress level itself and […]
Stretchy Coils to Make MRI Imaging Easier on Patients
When undergoing MRI scanning, many patients have to have the body parts being imaged strapped into rigid radio-frequency (RF) coils. These can be uncomfortable, as they’re not custom-sized for every patient, and since many MRI exams can take a half hour or more to perform, the scanning process can be difficult for many to undergo. […]
Fist Assist Helps Prep Vein for Dialysis Surgery, Lead to Healthy Fistula
Fist Assist Devices, a small Silicon Valley firm, won the European CE Mark for its eponymous wearable device. The Fist Assist works to widen the vein diameter in preparation for fistula placement and to help with fistula vein dilation in patients requiring hemodialysis. It is worn on the arm twice a day starting at about […]
ALPHASTROKE, A Better Way to Diagnose Strokes: Interview with CEO Matt Kesinger
Strokes affect nearly 800,000 Americans per year. One of the most important prognostic factors is the time from symptom onset to treatment. Currently, strokes are usually diagnosed by first-responders using a quick physical exam — a subjective method that can result in incorrect diagnoses, delayed treatment, and poor outcomes. Forest Devices hopes to change that. […]
Wearable Magnetic Stimulator for Stroke Recovery
Stroke can result in a variety of debilitating conditions caused by damaged neural connections within the brain. Researchers at the Eddy Scurlock Stroke Center at Houston Methodist Hospital in Texas have now successfully tested a wearable, multifocal, transcranial, rotating, permanent magnet stimulator (TRPMS) to boost neural activity near injured brain areas in patients recovering from […]
Abbott’s Gallant Cardiac Implants Cleared in Europe
Abbott won clearance in the European Union for its new Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) implants. The MRI compatible devices, which Abbott claims have an extended battery lifetime, can securely communicate with patients and physicians via Abbott’s myMerlinPulse smartphone app. Physicians can monitor their patients, including being able to […]
Tactile Enhancement to Compensate for Loss of Sensation
A variety of medical conditions, including diabetic neuropathy, infections, and injuries, can lead to a reduced ability to feel touch with one’s skin. This can be frustrating and uncomfortable, but it can also result in an inability to walk in comfort, notice wounds and injuries, and deal with everyday tasks. Now researchers in China are […]
Novalung FDA Cleared to Provide Long-Term Lung Failure Treatment
Critically ill patients with acute respiratory or cardiopulmonary failure who are on long-term mechanical ventilation too often suffer a variety of side effects. These can include ventilator associated lung injury, pneumonia, and diaphragm dysfunction. Moreover, related sedation and lack of movement can aggravate an already difficult situation. To help address these challenges, the FDA has […]
Contour Treats Brain Aneurysms Using Single Device
Cerus Endovascular, a firm based in Fremont, California, won the EU’s CE Mark for the Contour Neurovascular System, the company’s flagship product. Designed to treat intracranial aneurysms, the Contour is a mesh braid that diverts and disrupts blood flow in and out of an aneurysm. The device is positioned at the neck of the aneurysm […]