US Food and Drug Administration (FDA)

US Food and Drug Administration (FDA)

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2020
1 Apr 2020

AmCad BioMed

AmCad BioMed's devices are designed to enable early detection and diagnosis of various diseases, such as thyroid cancers, fatty liver, liver fibrosis and obstructive sleep apnea. The softwares developed by AmCad BioMed enable rapid analysis of ultrasound scan images.
31 Mar 2020

Eargo

IDTechEx interviewed Tim Trine, Chief Technical Officer at Eargo at their booth at the Showstoppers event at CES 2020. Their approach is to deliver their hearing aid product, a Class 1 FDA approved medical device, as a direct-to-consumer product.
30 Mar 2020

3D Printed Nasal Swabs to Test for COVID-19 in Emergencies

The University of South Florida Health, Formlabs and Northwell Health announced they have successfully produced and tested a 3D printed nasal swab to address emergency shortages that hospitals and health care teams may face as testing for COVID-19 increases.
27 Mar 2020

Innovative Ventilator Device for COVID-19 Patients

Prisma Health has received emergency use authorization from the US Food and Drug Administration for VESper, a unique ventilator expansion device that allows a single ventilator to support up to four patients during times of acute equipment shortages such as the current COVID-19 pandemic. Produced using 3D printing technology, the device is developed with material already in use for medical devices and produced at minimal cost.
24 Mar 2020

Aktiia Raises Funding for Cuffless Optical Blood Pressure Monitor

Aktiia, a Swiss-US startup that has developed an optical blood pressure monitor at the wrist, has raised an additional CHF 6 million in funding to bring its product to market.
19 Mar 2020

Smart Wound Healing Patch: DARPA Awards $22 Million Grant

Neuroengineers and bioengineers are part of a national team that's developing "smart" technology that combines artificial intelligence, bioelectronics and regenerative medicine to regrow muscle tissue for wounded soldiers.
18 Mar 2020

Potential "One-Hour" COVID-19 Diagnostic Test Developed

Physician-scientists at the University of California, San Diego are the first to evaluate a new diagnostic testing system designed by Fluxergy, that holds promise for identifying the SARS-CoV-2 virus (also known as the novel coronavirus) in as little as 45 minutes and typically within one hour.
10 Mar 2020

Vagus Nerve Stimulation Therapy Earns CE Mark for Depression Treatment

Now available in Europe, Symmetry is a small implantable device that stimulates the vagus nerve to improve symptoms of depression and quality of life. Symmetry sends mild electric pulses to the vagus nerve, which is connected to areas of the brain that control mood.
28 Feb 2020

Brainlab

IDTechEx spoke to Brainlab about Loop-X, a robotic imaging platform for intra-operative cone beam CT scanning. It generates 2D and 3D images of the area of interest. Loop-X is designed to facilitate surgical procedures for scoliosis, trauma and screw implantation because it enables surgeons to perform imaging during surgery without having to transfer the patient to radiology.
28 Feb 2020

AmCad BioMed

IDTechEx interviewed AmCad BioMed, a Taiwan-based company that developed a robotic platform for the rapid detection of obstructive sleep apnoea (OSA). OSA is vastly undiagnosed, with reports saying up to 85% of people with the condition are not aware they have it.
28 Feb 2020

Wandercraft

IDTechEx interviewed French company Wandercraft. Its product, Atalante, is a robotic rehabilitation exoskeleton for stroke victims and other people who have lost the ability to walk.
28 Feb 2020

Brainlab

Brainlab was exhibiting Brainlab Curve, a needle guidance system for spinal interventions such as screw implantation. Pre-operative computed tomography (CT) scans are conducted to obtain images of the patient's spine. During surgery, the patient wears markers on their back to enable the system to position the CT images in relation to the rest of the patient's body.
28 Feb 2020

ExoAtlet

Founded in 2014, ExoAtlet is a Russian company engaged in the development, production and commercialisation of exoskeletons. Its headquarters recently moved from Moscow to Luxemburg in order to pursue the European market more aggressively.
28 Feb 2020

Zeiss

Zeiss' Kinevo 900 was on display at Arab Health 2020. The platform enables surgical microscopy for neurosurgery by providing a detailed view of the surgical site.
26 Feb 2020

Artificial Intelligence Yields New Antibiotic

Using a machine-learning algorithm, researchers have identified a powerful new antibiotic compound. In laboratory tests, the drug killed many of the world's most problematic disease-causing bacteria, including some strains that are resistant to all known antibiotics. It also cleared infections in two different mouse models.
24 Feb 2020

MedWand

IDTechEx analyst Nadia Tsao spoke with MedWand's Director of Engineering, Scott Coleman, at CES 2020. MedWand have developed a diagnostics kit for remote patient monitoring.
21 Feb 2020

Bisu

IDTechEx analyst Nadia Tsao spoke with Bisu Co-founder & CEO Daniel Maggs at CES ShowStoppers 202. Bisu is a diagnostics company working on disposable home use tests. Their first product is a urine test for dietary health called the Bisu Body Coach
20 Feb 2020

BenQ Materials Corporation

Anscare, the brand of medical materials and supplies founded by BenQ Materials Corporation, was exhibiting its wound management device called SIMO Negative Pressure Wound Therapy (NPWT) System. The company is based in Taiwan.
20 Feb 2020

Brilliant & Company

IDTechEx analyst Nadia Tsao spoke with Ryan Yun, CEO and Founder of Pico Home at CES 2020. Brilliant is a South Korean company developing gas sensors for health monitoring. The company is four years old.
20 Feb 2020

FreMon Scientific

FreMon Scientific - based in San Diego, USA - was demonstrating ZipThaw, its portable blood thawing device. The company aims to render the process of thawing blood in hospitals more efficient and to reduce waste.