Medical Devices News and Research

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FDA's AI/ML-Based Software as a Medical Device Action Plan released

Today, the U.S. Food and Drug Administration released the agency's first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan describes a multi-pronged approach to advance the Agency's oversight of AI/ML-based medical software.

12 Jan 2021

FDA alerts health care providers and clinical laboratory staff about SARS-CoV-2 viral mutation

The U.S. Food and Drug Administration is alerting clinical laboratory staff and health care providers that the FDA is monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests, and that false negative results can occur with any molecular test for the detection of SARS-CoV-2 if a mutation occurs in the part of the virus's genome assessed by that test.

8 Jan 2021

Wireless medical device might help with weight loss

Gastric bypass surgery is sometimes the last resort for those who struggle with obesity or have serious health-related issues due to their weight.

8 Jan 2021

Novel color changing 'smart labels' will alert users to replace their face masks

Technology that will alert users to the need to replace their face mask has been unveiled by smart packaging company, Insignia Technologies.

23 Dec 2020

FDA issues first emergency use authorization for second COVID-19 vaccine

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

21 Dec 2020

Certain male enhancement and weight loss products may pose serious health risk, warns FDA

The U.S. Food and Drug Administration is warning consumers not to use nearly 50 male enhancement or weight loss products that have been found to contain hidden ingredients and may pose a significant health risk.

18 Dec 2020

Two school friends have joined forces to boost the global sales opportunities of the UK’s medical device manufacturers

James Hardie, and Mat Targowski, set up Sanollo, an innovative advisory specializing in helping the latest medical technologies enter new markets.

15 Dec 2020

FDA approves first IGA in GalSafe pigs for human food, promising therapeutic uses

Today, the U.S. Food and Drug Administration approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs, referred to as GalSafe pigs, which may be used for food or human therapeutics.

15 Dec 2020

Digital chest drainage systems could help reduce COVID-19 spread, research shows

Pioneering research, which reveals digital chest drains generate and distribute less aerosol generated particles compared to traditional water seal systems, has been published in the Seminars in Thoracic and Cardiovascular Surgery journal.

14 Dec 2020

FDA approves first COVID-19 direct-to-consumer test

Today, the U.S. Food and Drug Administration authorized LabCorp's Pixel COVID-19 Test Home Collection Kit for use by any individual 18 years and older without a prescription.

9 Dec 2020

Researchers develop potential non-drug, non-surgical, long-acting therapy for glaucoma

Researchers have developed a potential new treatment for the eye disease glaucoma that could replace daily eye drops and surgery with a twice-a-year injection to control the buildup of pressure in the eye.

7 Dec 2020

FDA authorizes first COVID-19 test to detect COVID-19, influenza A and B

Today, the U.S. Food and Drug Administration authorized the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu).

7 Dec 2020

Medical imaging startup gets FDA clearance for Liver Surface Nodularity software

AI Metrics, LLC, a medical imaging startup focused on leveraging artificial intelligence to improve patient care, has received United States Food and Drug Administration 510(k) clearance and CE mark clearance for the company's Liver Surface Nodularity software.

5 Dec 2020

Exactech and Bodycad sign exclusive distribution agreement

Exactech announced today the signing of an exclusive distribution agreement with orthopedic manufacturer Bodycad for its Reflex Uni™ knee in the U.S.

25 Nov 2020

Researchers use AI technology to evaluate speech disorders related to Parkinson's disease

The COVID-19 pandemic is leading a Purdue University innovator to make changes as she works to provide new options for people with Parkinson's disease.

24 Nov 2020

FDA schedules meeting to discuss emergency use authorization of COVID-19 vaccine from Pfizer

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19.

23 Nov 2020

FDA schedules meeting to discuss emergency use authorization of COVID-19 vaccine from Pfizer

The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH.

23 Nov 2020

Researchers develop nasal spray against COVID-19 virus

A nasal spray to provide protection against the COVID-19 virus has been formulated by researchers at the University of Birmingham, UK, using materials already cleared for use in humans.

20 Nov 2020

FDA approves first COVID-19 diagnostic test for at-home use

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results.

18 Nov 2020

Novel protein imaging method could lead to the development of new biomaterials

Scientists have established a new method to image proteins that could lead to new discoveries in disease through biological tissue and cell analysis and the development of new biomaterials that can be used for the next generation of drug delivery systems and medical devices.

17 Nov 2020

Medical Devices News and Research

FDA's AI/ML-Based Software as a Medical Device Action Plan released

FDA alerts health care providers and clinical laboratory staff about SARS-CoV-2 viral mutation

Wireless medical device might help with weight loss

Novel color changing 'smart labels' will alert users to replace their face masks

FDA issues first emergency use authorization for second COVID-19 vaccine

Certain male enhancement and weight loss products may pose serious health risk, warns FDA

Two school friends have joined forces to boost the global sales opportunities of the UK’s medical device manufacturers

FDA approves first IGA in GalSafe pigs for human food, promising therapeutic uses

Digital chest drainage systems could help reduce COVID-19 spread, research shows

FDA approves first COVID-19 direct-to-consumer test

Researchers develop potential non-drug, non-surgical, long-acting therapy for glaucoma

FDA authorizes first COVID-19 test to detect COVID-19, influenza A and B

Medical imaging startup gets FDA clearance for Liver Surface Nodularity software

Exactech and Bodycad sign exclusive distribution agreement

Researchers use AI technology to evaluate speech disorders related to Parkinson's disease

FDA schedules meeting to discuss emergency use authorization of COVID-19 vaccine from Pfizer

FDA schedules meeting to discuss emergency use authorization of COVID-19 vaccine from Pfizer

Researchers develop nasal spray against COVID-19 virus

FDA approves first COVID-19 diagnostic test for at-home use

Novel protein imaging method could lead to the development of new biomaterials

Industry Focus - Medical Device eBook

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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