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Hologic announced that its Cynosure division is releasing the recently FDA-cleared TempSure RF platform for surgical and non-surgical aesthetic applications. The device provides 300 watts of energy at 4 MHz, allowing for precise work in creating fine incisions in delicate tissues such as eyelids, ears, and even labia! Hologic believes its device causes less heat damage to nearby tissues compared to competitors and less noticeable scarring is left at the end. The device comes with a set of different electrodes that are dedicated to working with different tissue types on...
Cardiva Medical won FDA approval for its VASCADE MVP Venous Vascular Closure System, a device used for multi-site venous closure post cardiac ablation, left atrial appendage closure, and other electrophysiology procedures. It's available in sheaths from 6 to 12 French inner diameter The device is used to deliver a collagen patch onto the exterior of each vessel puncture site following the main procedure. Nothing remains within the vessel and the patch eventually breaks up and is resorbed into the body. The same site can be used for repeat access if...
ENT
Motion sickness can be a debilitating condition for many people, preventing them from traveling and engaging in various activities such as sailing. There are a few drugs available to control motion sickness, but they have side effects such as drowsiness and for many people are simply a choice of choosing one discomfort over another. A new device, developed by Otolith Labs, a company out of Washington, DC, may soon become a new, drug-free option for managing the symptoms of motion sickness. The Otolith device consists of a vibrating gadget, attached...
Nuvectra Corporation out of Plano, Texas, won European MR-conditional approval for its Algovita spinal cord stimulator to be safe while receiving full body MRI scans. The Algovita implant is used to control chronic intractable pain of the trunk and/or limbs. It has 24 independent current sources to stimulate the spinal cord in a variety of ways. It is rechargeable and The device currently has approval from the FDA for MRI scans to be safely done on the head, but not other body parts. "Full-body MR-conditional approval in Europe further validates...
At-home lab tests are growing in popularity. While many companies focus on specific tests, such as genetic testing or specific screenings, LetsGetChecked, a company with offices in New York, Dublin, and Toronto, hopes to be a central hub that allows people to regularly and affordably check a variety of basic lab work. As with most at-home testing companies, customers go online to order a test kit. Within a few days, they receive a box with the necessary tools and instructions to collect a fingerprick blood sample. That sample is sent back...
Retia Medical, out of Valhalla, New York, won FDA clearance and is making available in the U.S. its Argos Cardiac Output Monitor. For use in the OR and ICU, the product uses the company's MBA algorithm to track both fluid and pressor resuscitation with high precision. This gives clinicians the ability to monitor oxygen delivery and control fluid status. The Argos interfaces with many existing clinical monitors and electronic medical record (EMR) systems and eliminates some disposables that rack up cost over time. The company hopes that the set of features...
Optical coherence tomography (OCT) is an imaging technique that allows ophthalmologists to view the eye's blood vessels, to study the structure of tissues in various clinical and scientific applications. Though this technology is already widely used, there's been a constant demand to improve its imaging resolution. Researchers at Stanford have just added an interesting ingredient, namely nano-scale gold prisms, which can be injected into the bloodstream to significantly boost the quality of optical coherence tomography. The effect is so substantial that molecular-level details are able to be distinguished, potentially resulting...
Medtronic won FDA approval to introduce the InterStim smart programmer to control the company's InterStim neurostimulation system used to manage overactive bladder, bowel incontinence, and some types of urinary retention. The InterStim system delivers sacral neuromodulation therapy via an implant that looks similar to a cardiac pacemarker. The new InterStim smart programmer is a Samsung device with a Medtronic's app loaded onto it. It uses wireless connectivity to interface with the implant and the intuitive, touchscreen interface is used by clinicians to program the implant and by patients to discreetly control...
In the summer of 2018, VitalConnect launched the VistaTablet as an extension to their FDA-approved biosensor, the VitalPatch, which measures eight vital parameters. We have previously covered the VitalPatch and the launch of the VistaTablet, but we recently had the chance to check them out first-hand. The following is a review of this editor’s experience and impressions.   The Patch A slim and light gadget sitting at a width of <4cm, length of <12cm, and about half as thick as a standard wrist watch, the patch gives an unfortunate first impression: flimsy...
GI
Researchers at MIT, Draper, an engineering firm, and Harvard's Brigham and Women’s Hospital have developed an electronic wireless device that can stay inside the gut for long periods of time while releasing drugs into the body and measuring various parameters. The device has Bluetooth connectivity built in, and it can share its readings and trigger the release of a drug via a coupled smartphone app. The swallowable device can stay in the body for over a month and it can be manufactured to different specifications since it's 3D printed. Moreover, it...
ENT
Today, 500 million people globally suffer from hearing loss, however, most individuals wait on average seven years before dealing with the condition due to a combination of factors, including stigmas and misconceptions related to hearing aids. In the U.S. alone, an estimated 40 million individuals live with untreated hearing loss. Stepping in to address this need is Eargo, a U.S.-based hearing aid manufacturer that has been focused on creating products that are smaller, less visible, and more cost effective than traditional hearing aids since 2010. The company's Eargo Plus and Eargo...

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