US Food and Drug Administration (FDA)

US Food and Drug Administration (FDA)

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2020
15 May 2020

CRISPR Plants: New Non-GMO Method to Edit Plants

An NC State researcher has developed a new way to get CRISPR/Cas9 into plant cells without inserting foreign DNA. This allows for precise genetic deletions or replacements, without inserting foreign DNA. Therefore, the end product is not a genetically modified organism, or GMO.
13 May 2020

Aktiia Cuffless Blood Pressure Monitor Proven Accurate

Aktiia has developed a wrist-worn optical blood pressure monitor that can automatically take measurements around the clock without requiring a specific arm position.
13 May 2020

Trial of Bioelectronic Platform in Rheumatoid Arthritis Patients

SetPoint Medical has received Investigational Device Exemption approval from the US Food and Drug Administration to study its proprietary bioelectronic platform in patients with rheumatoid arthritis.
30 Apr 2020

MetaOptima

MetaOptima is a digital health tech company focused on dermatology. Its technology, a smartphone app and online platform, enables the tracking and mapping of moles on users' skin in order to predict and prevent skin cancer. The company offers two products designed to enhance standards of patient care while streamlining services for maximum efficiency: DermEngine and MoleScope.
30 Apr 2020

SkinVision

SkinVision has developed a smartphone app that allows users to understand their risk factors for skin cancer (including melanoma, squamous cell carcinoma, basal cell carcinoma and precancerous actinic keratosis). It enables users to detect skin cancer at an early stage as well as to keep track of their moles over time in order to monitor their evolution. SkinVision does not formally provide a diagnosis, but instead a risk assessment and recommendation.
27 Apr 2020

Intrasense

Intrasense aims to accelerate and leverage the use and interpretation of medical images (CT, MRI and X-ray) throughout the chain of care. This ranges from research, to screening, to diagnosis, to treatment planning, as well as lesions follow-up.
24 Apr 2020

Telehealth Rises to the Challenge During the COVID-19 Crisis

Telehealth has been poised to disrupt healthcare for many years, but unfortunately has faced a slow rise in adoption. This has changed in the COVID-19 crisis.
23 Apr 2020

Partnership for 3D Pharmaceutical Printing

Health care is poised for a potential giant leap forward thanks to the 3D printing of medications. To advance the technology and science of 3D pharmaceutical printing, Purdue University's College of Pharmacy and Aprecia Pharmaceuticals, LLC are launching a comprehensive collaboration on future 3DP pharmaceutical equipment and medications.
17 Apr 2020

Arterys

Arterys was founded to facilitate the global advancement of medicine through data, AI and technology. Its mission is to transform the world of medical imaging via high performance cloud computation.
16 Apr 2020

Quantib

Quantib's software is able to detect abnormalities that radiologists can't see with the naked eye. The company makes all the information captured in medical images available to radiologists, so they can detect diseases before symptoms start showing. The AI algorithms developed by Quantib help to identify specific brain disorders months before radiologists could perceive them using conventional methods.
16 Apr 2020

Therapixel

Therapixel applies artificial intelligence (AI) to medical imaging. Using various forms of AI, the company develops products to help healthcare professionals access images more easily and gain more value from them.
16 Apr 2020

Lunit

Lunit, abbreviated from "learning unit," is a Medical AI software company devoted to developing advanced medical image analytics and novel imaging biomarkers via cutting-edge deep learning technology. The company was founded in 2013 by six scientists from Korea Advanced Institute of Science and Technology (KAIST). Its initial interest was breast cancer, but the company has now moved to all kinds of chest diseases. Its end goal is to provide more AI solutions to enable the earlier diagnosis of disease or to predict its onset altogether. It focuses on oncology and radiology.
16 Apr 2020

ArtiQ

ArtiQ aims to support doctors in the diagnosis, treatment and follow-up of respiratory diseases. With its first artificial intelligence-based software, ArtiQ.PFT, it supports the interpretation of pulmonary function tests (PFTs) and improves the diagnostic environment for lung diseases.
16 Apr 2020

Subtle Medical

Unlike most AI radiology companies, Subtle Medical focuses on image acquisition rather than analysis. It is developing software solutions to improve the capture of high-quality medical images. More specifically, it transforms low resolution scans taken rapidly (eg: in 6 minutes) into high resolution scans that normally can only be obtained by running scans for 20+ minutes.
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.