Federal Food, Drug, and Cosmetic Act

Electromedical Technologies Announces Financial and Operational Highlights for the Three and Nine Months Ended September 30, 2022

Retrieved on: 
Monday, December 5, 2022
Cloud, Stock dilution, Federal Food, Drug, and Cosmetic Act, Retirement, Negotiation, Pain, VNS, Sale, IDNA, Loss, Research, PNS, Q1, ALL, CES, Low-level laser therapy, FDA, Bioelectronics, Overalls, EMS, POD, Growth, University, Infinity, PEMF, Marketing, TENS, Renewable energy, Pharmaceutical industry, Medical imaging, Video game console, Risk management

SCOTTSDALE, Ariz., Dec. 5, 2022 /PRNewswire/ -- Electromedical Technologies, Inc. (OTC-QB: EMED) ("Electromedical" or the "Company"), a pioneer in the development and production of bioelectronic devices designed to relieve chronic, intractable, and acute pain through frequency and electro-modulation, is pleased to provide its Financial and Operational Highlights for the three and nine months ended September 30, 2022.

Key Points: 
  • Electromedical Technologies Announces Financial and Operational Highlights for the Three and Nine Months Ended September 30, 2022
    SCOTTSDALE, Ariz., Dec. 5, 2022 /PRNewswire/ -- Electromedical Technologies, Inc. (OTC-QB: EMED) ("Electromedical" or the "Company"), a pioneer in the development and production of bioelectronic devices designed to relieve chronic, intractable, and acute pain through frequency and electro-modulation, is pleased to provide its Financial and Operational Highlights for the three and nine months ended September 30, 2022.
  • Highlights for the three and nine months ended Sep 30, 2022
    Strong net sales during the quarter totaling approximately $280,000, beating both Q1 and Q2 2022 sales.
  • Net loss for the nine months ended Sep 30, 2022, of $2.64 million, a 60% improvement over net loss for the nine months ended Sep 30, 2021.
  • Approximately $900K in net financing used to expedite development of the new WellnessPro Infinity Flagship Device.

VYRSA Technologies Announces Worldwide Launch of the VYRSA V1™ SI Fusion System

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Friday, December 2, 2022
SI, MIS, SIJ, Sacroiliac joint dysfunction, Sacroiliac joint, FDA, Pain, Federal Food, Drug, and Cosmetic Act, Patient, Ilium, Environment, Control, Anatomy, 3D, Sacrum, Medical device, Test

KING OF PRUSSIA, Pa., Dec. 2, 2022 /PRNewswire/ -- VYRSA Technologies, a specialty medical device firm, announced today the FDA clearance of the VYRSA V1™ SI Fusion System. After an extensive two 1/2-year biomechanical testing protocol, VYRSA Technologies submitted a comprehensive data set to the FDA showing overwhelming evidence of biomechanical stability in the sacroiliac joint after implantation of the VYRSA V1™ SI Fusion System.

Key Points: 
  • KING OF PRUSSIA, Pa., Dec. 2, 2022 /PRNewswire/ -- VYRSA Technologies, a specialty medical device firm, announced today the FDA clearance of the VYRSA V1 SI Fusion System.
  • After an extensive two 1/2-year biomechanical testing protocol, VYRSA Technologies submitted a comprehensive data set to the FDA showing overwhelming evidence of biomechanical stability in the sacroiliac joint after implantation of the VYRSA V1 SI Fusion System.
  • VYRSA V1 has multiple openings to allow a large volume of autogenous bone graft to be easily packed into the implant to facilitate fusion.
  • With an innovative portfolio of MIS allograft implants and innovative transfixing medical devices, VYRSA Technologies is uniquely positioned as an industry leader in sacroiliac fusion.

CorDx Receives FDA Emergency Use Authorization for COVID-19 Antigen Test

Retrieved on: 
Thursday, December 1, 2022
COVID-19, SAN, Diagnosis, Food, EUA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Protein, Federal Food, Drug, and Cosmetic Act, Virus, Health, Emergency Use Authorization, Severe acute respiratory syndrome coronavirus 2, FDA, Vaccine, Medical device

The CorDx COVID-19 Ag Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus.

Key Points: 
  • The CorDx COVID-19 Ag Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus.
  • "We're honored to utilize our integrated supply chain to provide the CorDx COVID-19 Ag Test to families in the United States."
  • The CorDx COVID-19 Ag Test has not been FDA cleared or approved.
  • For more information about the CorDx COVID-19 AG Test or to inquire about wholesale opportunities, visit cordx.com .

FDA's Import Alerts Webinar: Understand the nature of Import Alerts: What are they? What purpose do they serve? What do they mean for a company? - ResearchAndMarkets.com

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Thursday, December 1, 2022
FDA, Pharmaceutical, Health, Physical examination, FDC, Food, Human resource policies, CBP, Opera Company of Boston productions, Consultant, Capital, Federal Food, Drug, and Cosmetic Act, Database, FDA, Distribution (marketing), Dietary supplement, Medical device, Inspection

Import Alerts lets FDA Field Staff know that the agency has enough evidence or other information to refuse admission of future shipments of an imported article.

Key Points: 
  • Import Alerts lets FDA Field Staff know that the agency has enough evidence or other information to refuse admission of future shipments of an imported article.
  • There are a variety of factors that could lead FDA to place a product, manufacturer, shipper, grower, geographical area, and/or country on Import Alert.
  • During this time, the product is either held at a warehouse or at the importer's premises and cannot be distributed.
  • Regulatory Affairs Professionals, Managers, Consultants, Scientists, Research Analysts, State Policy Officials, Insurers focusing on Representations & Warranties Insurance; Investment Analysts; Venture Capitalists.

Surgical Innovation Associates (SIA) Announces Definitive Agreement to be Acquired by Integra LifeSciences

Retrieved on: 
Thursday, December 1, 2022
Research, General Health, Oncology, Medical Devices, Other Manufacturing, Science, Surgery, Chemicals, Plastics, Biotechnology, Medical Supplies, Manufacturing, Health, Warning, Growth, TCC, Weakness, Use, ICP, Sulfoxide, Merck KGaA v. Integra Lifesciences I, Ltd., Northwestern University, Ideation, Acquisition, Health, Physician, Patient, Integra, BofA Securities, Proskauer, Federal Food, Drug, and Cosmetic Act, PMA, News, Bank of America, Surgeon, CE, Entrepreneurship, Mastectomy, PRS, FDA, Health insurance, Medical device, Medical imaging, EU

Surgical Innovation Associates (SIA) today announced that it entered into a definitive agreement to be acquired by Integra LifeSciences Holding Corporation (Nasdaq: IART), a leading global medical technology company.

Key Points: 
  • Surgical Innovation Associates (SIA) today announced that it entered into a definitive agreement to be acquired by Integra LifeSciences Holding Corporation (Nasdaq: IART), a leading global medical technology company.
  • The transaction is expected to close by the end of the year, subject to the satisfaction of customary conditions.
  • Today, there are no surgical matrices approved by the FDA specifically for use in implant-based breast reconstruction (IBBR) for mastectomy patients.
  • Integra is the only manufacturer so far to submit a premarket approval (PMA) application for this soft tissue support in IBBR.

Irwin Naturals Leverages Household Brand Status in Effort to be World’s Largest Chain of Psychedelic Mental Health Clinics

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Wednesday, November 30, 2022
US Foods, Particle-size distribution, EBITDA, Substance-related disorder, Food, State, CSA, Physician, Education, Cannabis, Winners Don't Use Drugs, Schedule, Therapeutic drug monitoring, SEDAR, Canadian Securities Exchange, News, Food and Drug Administration, Controlled Substances Act, Sale, Federal Food, Drug, and Cosmetic Act, Schedule 3, Psilocybin, Ketamine, CSE, DEA, FDA, Pharmaceutical industry

State CSAs have either adopted drug schedules identical or similar to the federal CSA schedules or, in some instances, have incorporated the federal scheduling mechanism.

Key Points: 
  • State CSAs have either adopted drug schedules identical or similar to the federal CSA schedules or, in some instances, have incorporated the federal scheduling mechanism.
  • In the United States, facilities holding or administering controlled substances must be registered with the US Drug Enforcement Agency ("DEA") to perform this activity.
  • 1 Consumer brand recognition information is based on a Company survey with a sample size of 500 randomly selected adults.
  • 2 Under several corporate structures, Klee Irwin has operated the Irwin brand profitably since 1994, as measured by EBITDA adjusted for extraordinary costs.

Nanobionic Announces Global Partnership With La-Z-Boy Incorporated and Culp, Inc.

Retrieved on: 
Tuesday, November 29, 2022
Furniture, Comfort, Science, Elective surgery, Itech, Life, Partnership, Sleep, Human body, Mineral, Marketing, Attorney General Wells, Federal Food, Drug, and Cosmetic Act, Wholesaling, NASA, FDA, La-Z-Boy

NEW YORK, Nov. 29, 2022 (GLOBE NEWSWIRE) -- Nanobionicannounced a global partnership with La-Z-Boy Incorporated, a global leader in residential furniture, and Culp, Inc., one of the largest global marketers of upholstery fabrics for residential and commercial furniture.

Key Points: 
  • NEW YORK, Nov. 29, 2022 (GLOBE NEWSWIRE) -- Nanobionicannounced a global partnership with La-Z-Boy Incorporated, a global leader in residential furniture, and Culp, Inc., one of the largest global marketers of upholstery fabrics for residential and commercial furniture.
  • Nanobionic technology will now be used in Culp upholstery fabric that is exclusively offered in La-Z-Boy's newly launched Restore by Nanobionic furniture collection.
  • Every piece ofLa-Z-Boy Restore by Nanobionic furniture can now become a charging station for the human body."
  • "For 95 years, La-Z-Boy Incorporated has brought quality, comfortable furniture to consumers with an emphasis on innovative design and technology.

Philips debuts new AI-enhanced informatics solutions to increase diagnostic confidence with intelligence at every step of the radiology workflow at RSNA

Retrieved on: 
Monday, November 28, 2022
Pathology, Communication, Philips, Diagnosis, Stroke, Time-invariant system, Image, Infarction, AI, RIS, RSNA, Algorithm, Brain, Health, Radiological information system, Neurology, Patient, Radiology, CT, Informatics, Workflow, Federal Food, Drug, and Cosmetic Act, Radiological Society of North America, NYSE, Google Images, PHG, Intelligence, PACS, AEX, Cardiology, Acquisition, Medical imaging, Medical device

With simple and more efficient connected workflows, Philips solutions help reduce variability and staff workload, increase productivity, and enhance the patient and physician experience.

Key Points: 
  • With simple and more efficient connected workflows, Philips solutions help reduce variability and staff workload, increase productivity, and enhance the patient and physician experience.
  • At RSNA, Philips will introduce its next-generation Advanced Visualization Workspace platform with AI-enabled algorithms and workflows.
  • Visitors to the Philips booth (#6730) at RSNA will experience the expanded Philips Radiology Workflow , a combination of solutions that support clear and efficient radiology workflows.
  • For additional solutions featured in the Radiology Workflow and spotlighted at RSNA, visit the Philips RSNA Press Backgrounder .

Vir Biotechnology Ranked the Fastest-Growing Company in North America on the 2022 Deloitte Technology Fast 500™

Retrieved on: 
Wednesday, November 16, 2022
COVID-19, Growth, Patient, Hospital, GSK, SAN, Drug development, Hepatitis D, Immune system, Hepatitis B, Food, Health care, Caregiver, Risk, Safety, EUA, Emergency Use Authorization, Omicron, Bill, Deloitte Technology Fast 500, Fact sheet, Fact, HIV, National Accreditation Board for Hospitals & Healthcare Providers, Infection, Telecommunication, Letter, Federal Food, Drug, and Cosmetic Act, Death, Research, Bill & Melinda Gates Foundation, Severe acute respiratory syndrome coronavirus 2, FDA, Vaccine, Pharmaceutical industry, Dietary supplement, Parent

Now in its 28th year, the Deloitte Technology Fast 500 provides a ranking of the fastest-growing technology, media, telecommunications, life sciences, fintech and energy tech companies both public and private in North America.

Key Points: 
  • Now in its 28th year, the Deloitte Technology Fast 500 provides a ranking of the fastest-growing technology, media, telecommunications, life sciences, fintech and energy tech companies both public and private in North America.
  • Technology Fast 500 award winners are selected based on percentage fiscal year revenue growth from 2018 to 2021.
  • Additionally, companies must be in business for a minimum of four years and be headquartered within North America.
  • Vir Biotechnologyis a commercial-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases.

Brain Scientific Announces Release of Improved NeuroCap(TM) and New US Distribution Deal with D&D Medical

Retrieved on: 
Tuesday, November 15, 2022
D, D. Medical Industries, Epilepsy, Environment, Electrode, Diagnosis, Stroke, PET, Ambulance, Hospital, Projection, Partnership, Patient, Neurology, Government, Federal Food, Drug, and Cosmetic Act, EEG, OEM, Failure, OTCQB, Public expenditure, FDA, Medical device, Medical imaging

D&D Medical, Inc., brings innovative medical technologies to market by educating medical professionals in their use and distributing them to where they are needed most.

Key Points: 
  • D&D Medical, Inc., brings innovative medical technologies to market by educating medical professionals in their use and distributing them to where they are needed most.
  • Brain Scientifics newly improved NeuroCap recently entered production for the company and its distributors to build stock and fulfill customer requests.
  • Our improved NeuroCap is a more comfortable, easy-to-use, and efficient way to conduct EEG exams, said Hassan Kotob, chairman and CEO of Brain Scientific.
  • Brain Scientific is committed to developing next-gen solutions that advance the future of neurodiagnostic and OEM medical devices.