Federal Food, Drug, and Cosmetic Act

Positron Corporation Enters into Agreement with Ochsner Clinic Foundation for Clinical Study of its New “Affinity PET-CT 4D” Device

Retrieved on: 
Wednesday, March 1, 2023
Clinical trial, Cardiology, Clinical, Safety, Certification, International Committee for the Nanking Safety Zone, Affinity, IDE, Molecular imaging, Ochsner Health System, OTC, Institutional review board, FDA, Trial of the century, IRB, PMA, POSC, PET, Federal Food, Drug, and Cosmetic Act, Biomedical Research, Positron Corporation, Medical imaging, Positron

All procedures and participants for the clinical study have been evaluated and approved as required by an independent Institutional Review Board (IRB).

Key Points: 
  • All procedures and participants for the clinical study have been evaluated and approved as required by an independent Institutional Review Board (IRB).
  • Acceptance of the clinical study by the IRB allows Positron to obtain an Investigational Device Exemption (IDE) which is required to collect safety and efficacy data for Positron’s new PET-CT device.
  • The clinical study will be registered in accordance with the requirements of the International Committee of Medical Journal Editors.
  • Positron expects completion of its clinical study and FDA Certification within the next 60 days.

Applied BioCode Announces 2022 Q4 and Full year Revenue

Retrieved on: 
Monday, February 27, 2023
FDA, Chemicals, Plastics, Manufacturing, Technology, Nanotechnology, Public Relations, Investor Relations, Other Travel, Communications, General Health, Travel, Other Manufacturing, Other Technology, Science, Other Science, Research, Health, Bacteria, CE marking, Emergency Use Authorization, Autoimmune disease, RPP, Overalls, Diagnosis, Fungus, IVD, RSV, Federal Food, Drug, and Cosmetic Act, Microbiology, Bachelor, Parasitism, Laboratory, Virus, Patient, Nomenclature codes, RUO, Growth, Immunochemistry, BMB, Yoy, Molecular Probes, Syndromic testing, Allergy, EUA, GPP, Hair, Infection, COVID-19, COVID, SARS-CoV-2, Video game, Vaccine

Applied BioCode announced today its 2022 revenue $13MM, which marks 13% growth year over year, hitting the company’s historic high.

Key Points: 
  • Applied BioCode announced today its 2022 revenue $13MM, which marks 13% growth year over year, hitting the company’s historic high.
  • Q4 revenue was just shy of $4MM representing 9% growth quarter over quarter.
  • Applied BioCode, Inc. has also been granted an Emergency Use Authorization (EUA) from the U.S. FDA for its BioCode® CoV-2 Flu Plus Assay ⱡ, BioCode® SARS-CoV-2 Assay*, and an additional EUA for Pooled COVID-19 Testing*.
  • Applied BioCode also partners with a variety of diagnostic companies with applications that include the infectious disease, autoimmune disease, allergy, gut microbiome, and veterinary markets.

Non-invasive Prenatal Testing Global Market Report 2023: Rising Incidence of Down's Syndrome Fuels Growth - ResearchAndMarkets.com

Retrieved on: 
Friday, February 24, 2023
Biotechnology, Genetics, Health, Benchmark, NGS, Cell division, LDT, Create, Safety, Labcorp, Agriculture, Coronavirus, Genome, DNA, MUFG Americas Holdings Corporation, Acquisition, Risk, FDA, Miscarriage, Abortion, CLIA, Growth, Chromosome, Government, NIPT, US Foods, Ariosa v. Sequenom, Certification, Federal Food, Drug, and Cosmetic Act, Fetus, Down syndrome, CFDA, Incidence, GDP, National Down Syndrome Society, Disease, Dietary supplement, Birth control, Fine chemical, Medical device, Marketing, Video game, Natera, Illumina, Englan

The "Non-invasive Prenatal Testing Global Market Report 2023" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Non-invasive Prenatal Testing Global Market Report 2023" report has been added to ResearchAndMarkets.com's offering.
  • The regions covered in the non-invasive prenatal testing market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
  • The increased risk of having babies with Down syndrome among older women drives the non-invasive prenatal testing market.
  • The non-invasive prenatal testing market is regulated by several regulations that are governed by multiple international and country-specific agencies.

Remidio's Revolutionary AI on a smartphone for Referable Diabetic Retinopathy (DR) Receives EU MDR Class II Regulatory Approval

Retrieved on: 
Thursday, February 23, 2023
Diabetes, Moorfields Eye Hospital, Paratriathlon, Smartphone, DR, Research, FDA, Health Sciences Authority, Patient, Instituto de Química Física de los Materiales, Medio Ambiente y Energía, AI, HSA, Sale, Dietary Reference Intake, Professor, Federal Food, Drug, and Cosmetic Act, Deep learning, Outline of health sciences, Physician, Medicine, Medical device

BANGALORE, India, Feb. 23, 2023 /PRNewswire/ -- Remidio has received CE mark approval for its Medios AI, to detect Referable DR. This approval closely follows the nod the AI received from Singapore's Health Sciences Authority (HSA), assuring compliance with the highest standards.

Key Points: 
  • BANGALORE, India, Feb. 23, 2023 /PRNewswire/ -- Remidio has received CE mark approval for its Medios AI, to detect Referable DR.
  • This approval closely follows the nod the AI received from Singapore's Health Sciences Authority (HSA), assuring compliance with the highest standards.
  • Dr. Divya Rao, Remidio's Medical Director & Head of AI, called the approval a 'key milestone' as the first step towards transforming global DR screening.
  • Remidio's vision to eradicate preventable blindness has led it to publish research on a device-agnostic application for Medios DR AI.

Remidio's Revolutionary AI on a smartphone for Referable Diabetic Retinopathy (DR) Receives EU MDR Class II Regulatory Approval

Retrieved on: 
Thursday, February 23, 2023
Diabetes, Moorfields Eye Hospital, Paratriathlon, Smartphone, DR, Research, FDA, Health Sciences Authority, Patient, Instituto de Química Física de los Materiales, Medio Ambiente y Energía, AI, HSA, Sale, Dietary Reference Intake, Professor, Federal Food, Drug, and Cosmetic Act, Deep learning, Outline of health sciences, Physician, Medicine, Medical device

BANGALORE, India, Feb. 23, 2023 /PRNewswire/ -- Remidio has received CE mark approval for its Medios AI, to detect Referable DR. This approval closely follows the nod the AI received from Singapore's Health Sciences Authority (HSA), assuring compliance with the highest standards.

Key Points: 
  • BANGALORE, India, Feb. 23, 2023 /PRNewswire/ -- Remidio has received CE mark approval for its Medios AI, to detect Referable DR.
  • This approval closely follows the nod the AI received from Singapore's Health Sciences Authority (HSA), assuring compliance with the highest standards.
  • Dr. Divya Rao, Remidio's Medical Director & Head of AI, called the approval a 'key milestone' as the first step towards transforming global DR screening.
  • Remidio's vision to eradicate preventable blindness has led it to publish research on a device-agnostic application for Medios DR AI.

Casana Appoints New CTO To Accelerate Technological Innovation in Remote Patient Monitoring

Retrieved on: 
Tuesday, February 21, 2023
ISO, International Journal of Software and Informatics, Regulatory affairs, NGS, Quality assurance, FDA Center for Devices and Radiological Health, Medtronic, Device, Federal Food, Drug, and Cosmetic Act, Galileo Galilei, CDRH, Knowledge, FDA, Growth, Heart failure, Informatics, Medical device, Pharmaceutical industry, Teodoro Casana Robles, Software, Computer security

Zahine brings more than two decades of experience in medical device and software development within the healthcare space to propel Casana into its next phase of growth.

Key Points: 
  • Zahine brings more than two decades of experience in medical device and software development within the healthcare space to propel Casana into its next phase of growth.
  • Prior to Casana, Zahine served as Vice President of Software and Informatics at Cantata Bio, assisting in the launch of the metagenomic NGS product, Galileo-ONE.
  • Zahine also served as the Director of Software Engineering for both Abbott and Medtronic, overseeing the expansion of surgical and heart failure divisions.
  • "Sam is a fantastic addition to Casana’s executive team,” says Kara Johnson, VP of Regulatory Affairs and Quality Assurance at Casana.

The Worldwide Hip Replacement Industry is Expected to Reach $9 Billion by 2028 - ResearchAndMarkets.com

Retrieved on: 
Monday, January 23, 2023
Surgery, Health, Medical Devices, Hip, Government, Hospital, Rheumatoid arthritis, World Health Organization, Niece and nephew, Johnson & Johnson, General surgery, Patient, Arthritis, Stryker, Necrosis, Federal Food, Drug, and Cosmetic Act, WHO, Disease, FDA, Joint Commission on Allied Health Personnel in Ophthalmology, Fracture, Bone, Osteoarthritis, Medical device, Nursing, Growth

The Global Hip Replacement Market will be around US$ 9 Billion by 2028 according to the publisher.

Key Points: 
  • The Global Hip Replacement Market will be around US$ 9 Billion by 2028 according to the publisher.
  • Hip replacement is a surgical procedure to replace the hip joint entirely or partially with an artificial joint, called a prosthesis.
  • Based on products, the global hip replacement market is segmented into; total hip replacement, partial hip replacement, and revision and hip resurfacing.
  • Total hip replacement segments dominated the market share due to the growth in demand for minimally invasive surgeries and the technological advancements in the hip replacement market.

Montmed Inc. Announces Issuance of a second US Patent for Sitesmart Pen Needles

Retrieved on: 
Thursday, February 16, 2023
Science, Patent, Insulin, Randomized controlled trial, Needle, Rotation, Patient, Teaching, Growth hormone, Software, Skin, Hypoglycemia, Behavior, Diabetes, Risk, Federal Food, Drug, and Cosmetic Act, Trauma, Lipohypertrophy, Pharmaceutical industry

Studies have shown that the lack of injection site rotation is the largest risk factor in developing lipohypertrophy2.

Key Points: 
  • Studies have shown that the lack of injection site rotation is the largest risk factor in developing lipohypertrophy2.
  • Montmed has developed the Sitesmart™, a novel pen needle system designed to favor the teaching and adherence to a healthy injection site rotation regimen.
  • The study showed Sitesmart delivered a 134.7% increase in the likelihood to improve site rotation over conventional pen needles, without adding any cost to the health care system.
  • The study demonstrated that, in addition to ensuring healthy injection site rotation, needle re-use was reduced by 25% in Sitesmart users.

Pediatric Medical Devices Market to be Worth $51.9 Billion by 2030: Grand View Research, Inc.

Retrieved on: 
Tuesday, February 14, 2023
Federal Food, Drug, and Cosmetic Act, Hospital, Personal protective equipment, Saint Petersburg State Pediatric Medical University, Kid, Cystic fibrosis, Patient, Asthma, Anesthesia, Diabetes, Cardiology, USD, Revenue, IVD, Child care, FDA, SAN, Conditional sentence, Epilepsy, Prevalence, Quality of life, COVID-19, Medical device, Nursing, Birth control

Read 110 page market research report, " Pediatric Medical Devices Market Size, Share & Trends Analysis Report By Product (Cardiology Devices, In Vitro Diagnostic (IVD) Devices, Diagnostic Imaging Devices), By End-user, By Region, And Segment Forecasts, 2023 - 2030 ", published by Grand View Research.

Key Points: 
  • Read 110 page market research report, " Pediatric Medical Devices Market Size, Share & Trends Analysis Report By Product (Cardiology Devices, In Vitro Diagnostic (IVD) Devices, Diagnostic Imaging Devices), By End-user, By Region, And Segment Forecasts, 2023 - 2030 ", published by Grand View Research.
  • In the U.S., the commercialization and development of pediatric medical devices lag significantly behind the medical devices for adults.
  • The reopening of manufacturing units and supply-chain is expected to grow the market of pediatric medical devices.
  • Grand View Research has segmented the global pediatric medical devices market based on product, end-user, and region:
    Pediatric Medical Devices Market - Product Outlook (Revenue, USD Million, 2018 - 2030)

U.S. Rep. Cherfilus-McCormick Introduces Legislation to Protect Children From Flavored Disposable E-Cigarettes

Retrieved on: 
Sunday, February 12, 2023
Federal Food, Drug, and Cosmetic Act, Disposable product, Life, ENDS, Human services, Smoking, Trump administration political interference with science agencies, Immigration policy of the Joe Biden administration, Korea Disease Control and Prevention Agency, Tobacco, Herbal cigarette, Safety, Big Tobacco, American Heart Association, United States Department of Health and Human Services, Sale, Food, Advanced glycation end-product, Section 2 of the Canadian Charter of Rights and Freedoms, Risk, Congress, Student, Nicotine, FDA, Cosmetic, Presidency of Donald Trump, Regulation of tobacco by the U.S. Food and Drug Administration, Advocacy

WASHINGTON, Feb. 12, 2023 /PRNewswire-PRWeb/ -- Rep. Shelia Cherfilus-McCormick (D-FL) introduced the Disposable ENDS Product Enforcement Act of 2023 to close the Trump Administration's loophole on disposable electronic nicotine delivery systems (ENDS) (i.e., disposable vapes) containing flavors specifically intended to entice our children into becoming hooked on nicotine for life.

Key Points: 
  • "As the mother of two children and a former healthcare executive, I am pleased to introduce this critical legislation," said Rep. Cherfilus-McCormick.
  • "Too many of our youth are forming nicotine addictions, increasing their risk of future addiction to other drugs.
  • This left an opening for companies to swoop in and sell disposable versions of the e-cigarettes with the very same flavors intended to be taken off the shelves to protect our children.
  • However, since flavored disposable e-cigarettes are still available under federal law, thanks to the Trump Administration's loophole, they can be sold outside the city limits and made readily available to the children of Broward County.