US Food and Drug Administration (FDA)

US Food and Drug Administration (FDA)

HQ Country
United States
Filtered by:
US Food and Drug Administration (FDA)
Company
Topic
Show
 
2021
8 Oct 2021

SteadySense

SteadySense is a wearable skin patch industry company with core hardware in temperature monitoring. Their current focus is on temperature-based ovulation monitoring in the fertility technology sector. IDTechEx analysts James Hayward and Andy Ko interviewed SteadySense CEO and founder Werner Koele in 30 Sep 2021.
4 Oct 2021

Colorimetrix

Colorimetrix is a diagnostics industry company with a core software that processes analog colorimetric tests. Their current focus is on hormone diagnostics for ovulation monitoring in the fertility technology sector. IDTechEx analysts Nadia Tsao and Andy Ko interviewed Colorimetrix CEO and Cofounder Dr Leo Martinez on 29 Sep 2021.
28 Sep 2021

Nanowear

IDTechEx interviewed Venk Varadan, Co-Founder and CEO of Nanowear. They are developing a new type of nanotechnology-based sensing material in textile, with applications in AI-based remote diagnostics applications.
28 Sep 2021

Know Labs Expands Non-Invasive Glucose Monitoring Product Portfolio

The KnowU is a convenient, non-wearable, on-the-go alternative to fingersticks, which are used to check blood glucose levels, often multiple times per day, by more than 90% of the global population with diabetes.
27 Sep 2021

Micro-Robots Propelled by Air Bubbles and Ultrasound

A team of engineers created cell-size robots that can be powered and steered by ultrasound waves. Despite their tiny size, these micro-robotic swimmers - whose movements were inspired by bacteria and sperm - could one day be a formidable new tool for targeted drug delivery.
22 Sep 2021

First-in-World Heart Implant: Women Receives Novel Artificial Heart

A cardiothoracic surgical team has performed the world's first Aeson bioprosthetic total artificial heart implantation in a female patient. The investigational device, currently intended as a bridge to heart transplant, is part of an Early Feasibility Study.
21 Sep 2021

First Coffee Produced with Cellular Agriculture

Researchers have successfully produced coffee cells in a bioreactor through cellular agriculture. The innovation can help to make the production of coffee more sustainable. The first batches produced in a laboratory in Finland smell and taste like conventional coffee.
23 Aug 2021

3D Printed, Biocompatible Graft Could Repair Damaged Ear Drum

The PhonoGraft device is a 3D-printed, biocompatible graft that could be implanted to repair a damaged eardrum. If its clinical development is successful, the PhonoGraft technology could mitigate the pain, drainage, and hearing loss associated with ear drum perforations that affect millions of individuals worldwide.
16 Aug 2021

HelpWear

HelpWear have developed a clinical grade ECG armband that detects and flags cardiac events. The device in it's current form is worn on the upper arm and monitors the PQRST segments of the electrocardiogram. They presented their latest progress at Cardio Wearables 2021.
16 Aug 2021

Medtronic

At Cardio Wearables 2021, Dr Rohan Sonawane, Sr Medical Affairs Program Manager, presented Medronic's product offerings in the cardiac rhythm space, focusing on their Reveal LINQ™ implantable cardiac monitor.
13 Aug 2021

Low Cost Device For Consumers to Home Test Themselves for SARS-CoV-2

With the Delta variant wreaking havoc on unvaccinated populations and COVID-19 cases spiking around the world, the pandemic is far from over. Despite the impressively fast development of SARS-CoV-2 diagnostic tests over the last year and a half, the vast majority of patient samples must still be sent to a lab for processing, which slows down the pace of COVID-19 case tracking. If a sample is to be tested for a specific variant of the virus, it must be genetically sequenced, which takes even more time and resources.
10 Aug 2021

FibriCheck

FibriCheck is a Belgian startup that has developed an software-based solution for the detection of atrial fibrillation, a heart rhythm disorder. IDTechEx analyst Nadia Tsao interviewed FibriCheck Project Manager Felicia Vaz on 5 Aug 2021.
5 Aug 2021

Implant Shows Extreme Promise for Regenerating Bone

Researchers developed a biodegradable, nanofiber-based implant, or scaffold, whose design could better regenerate bone by effectively guiding the migration of recuperative cells to the injury site. When implanted in rats with bone defects, the cylindrical scaffold promoted the regeneration of bone that was denser, more voluminous and more like the surrounding tissue than that achieved by many other state-of-the-art designs.
16 Jul 2021

Artificial Intelligence New Blueprint for Precision Drug Discovery

A new approach that uses machine learning to hunt for disease targets and then predicts whether a drug is likely to receive FDA approval.
7 Jul 2021

Self Powered Implantable Device Stimulates Bone Healing, Disappears

Researchers know that electricity can help speed up bone healing, but "zapping" fractures has never really caught on, since it requires surgically implanting and removing electrodes powered by an external source.
6 Jul 2021

Continuous Composites

Continuous Composites is a start-up company that work on continuous fiber 3D printing with a thermoset resin.
28 Jun 2021

Vagus Nerve Stimulation Effect on Brain Activity

A new study adds to a growing body of research on the role of the vagus nerve in brain function and will help health care providers to select optimal clinical practices of using vagus nerve stimulation to treat diseases.
24 Jun 2021

Bio-Inspired Hydrogel Protects the Heart from Post-Op Adhesions

A hydrogel that forms a barrier to keep heart tissue from adhering to surrounding tissue after surgery was developed and successfully tested in rodents. The team of engineers, scientists and physicians also conducted a pilot study on porcine hearts, with promising results.
8 Jun 2021

Super Productive 3D Bioprinter Could Help Speed up Drug Development

A 3D printer that rapidly produces large batches of custom biological tissues could help make drug development faster and less costly. Nanoengineers developed the high-throughput bioprinting technology, which 3D prints with record speed--it can produce a 96-well array of living human tissue samples within 30 minutes. Having the ability to rapidly produce such samples could accelerate high-throughput preclinical drug screening and disease modeling.
4 Jun 2021

CRISPR-Based Coronavirus Rapid Test

While the coronavirus pandemic has proven once more that the tiniest germ can upset global civilization, a team has responded by illustrating that ancient strategies used by bacteria to battle viruses can be repurposed into transformative technologies.