Federal Food, Drug, and Cosmetic Act

Leading Food-and-Drug Lawyer John Fuson Joins Kleinfeld Kaplan & Becker LLP as Partner

Retrieved on: 
Tuesday, July 18, 2023
Legal, Pharmaceutical, Health, FDA, Professional Services, Food, Beverage, Cosmetics, Retail, LLP, Advertising, Medicaid, University, Poultry, Kaplan, Senior counsel, Food and Drug Administration, Ground substance, Tobacco, Private practice, Associate, Crowell, Federal Food, Drug, and Cosmetic Act, Medicare, KKB, Dietary supplement, Seizure, Cannabis, Container deposit legislation in the United States, Heated tobacco product, Meat, Safety, Pharmaceutical industry

Kleinfeld Kaplan & Becker LLP (KKB) is pleased to announce that John Fuson has joined the firm as a partner.

Key Points: 
  • Kleinfeld Kaplan & Becker LLP (KKB) is pleased to announce that John Fuson has joined the firm as a partner.
  • For the last 11 years, he has maintained a successful private practice focused on counseling clients on FDA’s requirements for product approval, safety, manufacturing, and labeling.
  • “John is an outstanding food and drug lawyer,” said Dan Dwyer, KKB's managing partner.
  • Kleinfeld Kaplan & Becker LLP is a Washington DC boutique law firm that has focused on food-and-drug and advertising law issues for over 60 years.

United Imaging, Kicking off a Birthday Celebration of Five Years in the U.S. Market, Will Debut Three New Scanners at AHRA

Retrieved on: 
Wednesday, July 5, 2023
Acceleration, Federal Food, Drug, and Cosmetic Act, CT, SNMMI, Senior, Noise, UVision Air, Workflow, Curriculum, Life, Intelligence, MRI, Umi, Software Upgrade Protocol, Radiation, Patient, AI, Environment, AHRA, ATLAS, Medical imaging

HOUSTON, Texas, July 5, 2023 /PRNewswire/ -- United Imaging, a global leader in manufacturing advanced medical imaging and radiotherapy equipment, continued its acceleration in investment and innovation for the U.S. market by announcing plans to officially show three new commercially available products (in MRI, DR, and CT), in Indianapolis at the AHRA Annual Meeting.

Key Points: 
  • United Imaging today manufactures scanners in four imaging modalities for the United States.
  • We've just not experienced that because of the way we are so vertically integrated throughout Houston and our other factories."
  • And third, we invest heavily in reducing the noise and increasing homogeneity in the system versus simply increasing signal.
  • That allows higher imaging quality in reduced time slots, to increase exams without expanding staffing or hours of operation."

Health app developers: Updated interactive tool can help you get started on compliance

Retrieved on: 
Saturday, July 1, 2023
Online, Accountability Act, Office of the National Coordinator for Health Information Technology, Health Insurance Portability and Accountability Act, Federal Trade Commission Act of 1914, Industry, COPPA, Federal Trade Commission, Policy, Record, Blog, Privacy, Federal Food, Drug, and Cosmetic Act, OCR, ONC, Best practice, Social Security, FTC, Comment, Compliance, Civil and political rights, Social, Fraud, FDA, HIPAA, 21st Century Cures Act, Medical device, Online shopping

The FTC just released an updated Mobile Health App Interactive Tool to help industry members determine what federal laws and regulations might apply to their apps.

Key Points: 
  • The FTC just released an updated Mobile Health App Interactive Tool to help industry members determine what federal laws and regulations might apply to their apps.
  • A quick look at the updated interactive tool demonstrates how easy the process is.
  • To be clear, the interactive tool can’t substitute for personalized legal advice, but it can give you a head start on compliance.
  • Also on your must-read list: Mobile Health App Developers: FTC Best Practices, which presents a series of issues for health app developers to consider.

PathKeeper Surgical Commercializes Spine Navigation System with First U.S. Cases

Retrieved on: 
Tuesday, June 27, 2023
Federal Food, Drug, and Cosmetic Act, Radiation, Sports medicine, Chevy Chase, Anatomy, 3D, Health, Degenerative disc disease, Instrument, KFAR, Operating, FDA, Dentistry, Medical device, MD

KFAR SABA, Israel, June 27, 2023 /PRNewswire/ -- PathKeeper Surgical, a privately-held, Israel-based, medical technology company, dedicated to improving the health of individuals around the world suffering from all spinal issues requiring surgery, while making navigation-guided surgery available to any patient in all operating rooms, announces the first commercial use of the PathKeeper, 3D optical navigation system in the United States.

Key Points: 
  • The surgical debut of the PathKeeper System took place during two lumbar spinal fusion surgeries for degenerative disc disease at VHC Health in Arlington, VA.
  • "The PathKeeper system is the first, clinically relevant navigation system in a long time, said Dr. Patel.
  • PathKeeper Surgical received its FDA 510k clearance earlier this year for the PathKeeper system.
  • The name PathKeeper effectively describes the essence of the system - a 3D optical navigation system that 'keeps' the surgical 'path' on course throughout the surgery.

United Imaging Introduces Next-Generation PET/CT Systems and Integrated Molecular Technology Platform at SNMMI

Retrieved on: 
Sunday, June 25, 2023
Acceleration, Yale University, Unmatched, Federal Food, Drug, and Cosmetic Act, CT, University of California, Davis, Total body irradiation, University, SNMMI, NEMA, Molecule, Unprecedented, Molecular imaging, UDP, PET, Biomedical engineering, Umi, Huntsman Cancer Institute, Radiation, Patient, UC, PET/CT, Artificial intelligence, Panorama, Research, AI, FOV, News, Invitation, ASIC, Medical imaging, Medical device, Radiology

HOUSTON, June 25, 2023 /PRNewswire/ -- United Imaging, a global leader in manufacturing advanced medical imaging and radiotherapy equipment and a Leadership Circle sponsor at this year's SNMMI, is making news on several fronts at SNMMI's annual meeting in Chicago this week.

Key Points: 
  • The uMI Panorama was teased recently in the media as one of United Imaging's four new products in four different imaging modalities so far this year.
  • United Imaging is showcasing a cutting-edge Molecular Imaging technology platform along with the uMI Panorama, called uExcel.
  • SNMMI announced in its Value Initiative Newsletter that United Imaging is joining the Leadership Circle and taking an Industry co-chair position.
  • uMI Panorama Symposium on June 26: "Advancing Precision Medicine with Unprecedented PET/CT Technology for Clinical Molecular Imaging" on Monday, June 26, from 11:30 am – 12:30 pm.

Dr. PRP USA Receives FDA 510K Clearance for Its PRP Kits

Retrieved on: 
Wednesday, June 21, 2023
Tissue, Injection, Learning, Male, PMN, Cell, Cosmetic, Sale, United States Department of Veterans Affairs, PRP, Federal Food, Drug, and Cosmetic Act, Blood, Veterans' affairs, Carpal tunnel syndrome, Federation, FDA, Trauma, Food, Wound healing, Medical device, Foodservice, Medical imaging

STAFFORD, Texas, June 21, 2023 /PRNewswire-PRWeb/ -- Dr. PRP USA LLC is proud to announce it has received 510K approval from the Food & Drug Administration (FDA) for its PRP kits. Now that the 510K clearance is final, Dr. PRP can continue to expand its market providing PRP kits to medical providers.

Key Points: 
  • Dr. PRP USA LLC has secured 510K clearance from the FDA for its Platelet Rich Plasma (PRP) kits.
  • STAFFORD, Texas, June 21, 2023 /PRNewswire-PRWeb/ -- Dr. PRP USA LLC is proud to announce it has received 510K approval from the Food & Drug Administration (FDA) for its PRP kits .
  • Now that the 510K clearance is final, Dr. PRP can continue to expand its market providing PRP kits to medical providers.
  • But now Dr. PRP USA has received a full 510K clearance from the FDA as well.

PathKeeper Surgical Receives FDA 510k Clearance for Spine Navigation System

Retrieved on: 
Thursday, June 15, 2023
Federal Food, Drug, and Cosmetic Act, Radiation, Surgeon, Anatomy, 3D, Spine, Instrument, KFAR, Operating, Patient, Health, FDA, Medical device, MD

KFAR SABA, Israel, June 15, 2023 /PRNewswire-PRWeb/ -- PathKeeper Surgical, a privately-held, Israel-based, medical technology company, dedicated to improving the health of individuals around the world suffering from all spinal issues requiring surgery, while making navigation-guided surgery available to any patient in all operating rooms, received its U.S. Federal & Drug Administration (FDA) 510(k) clearance for its PathKeeper, 3D optical navigation system.

Key Points: 
  • "There is a definite need for a new navigation system that is adaptable and easily integrated into operating rooms.
  • PathKeeper took that challenge and created a spine navigation system that is easily operated, offers real-time tracking and eliminates radiation exposure during the procedure.
  • PathKeeper Surgical received its FDA 510k clearance earlier this year for the PathKeeper system.
  • The name PathKeeper effectively describes the essence of the system - a 3D optical navigation system that 'keeps' the surgical 'path' on course throughout the surgery.

Autifony Therapeutics announces commencement of a US Phase Ib study of AUT00201, a novel Kv3 modulator, in Progressive Myoclonic Epilepsy-7 (EPM7)

Retrieved on: 
Tuesday, June 13, 2023
Science, Neurology, Biotechnology, Research, Pharmaceutical, Health, FDA, Clinical Trials, Epilepsy, Myenteric plexus, Seizure, University, Ataxia, Speech, Myoclonus, Biomarker, CNS, Hospital of the University of Pennsylvania, Federal Food, Drug, and Cosmetic Act, Incidence, US, KCNC1, Generalized tonic–clonic seizure, Patient, Central nervous system disease, Phases of clinical research, Medicine, Progressive myoclonus epilepsy, Neurological disorder, Ageing, Myoclonic epilepsy, Hospital, Therapy, Phenotype, Eurosport 1, Pharmaceutical industry, Potassium

It is the fourth most common neurological disorder worldwide.

Key Points: 
  • It is the fourth most common neurological disorder worldwide.
  • EPM7 symptoms typically emerge between the ages of 3 and 15, with progressively severe myoclonus, ataxia, and occasional tonic-clonic seizures.
  • Current anti-seizure drugs can help to reduce the incidence of tonic-clonic seizures, but these drugs do not improve the myoclonus or ataxia.
  • The Office of Orphan Products Development has also granted orphan drug designation for AUT00201 for the treatment of EPM7.

EOS, Tecomet, Inc., Precision ADM, and OIC Partner to Provide End-To-End Solution for Medical Device Additive Manufacturing

Retrieved on: 
Tuesday, June 13, 2023
EOS, ADM, Federal Food, Drug, and Cosmetic Act, Partnership, OIC, Original equipment manufacturer, Printing, 3D, Sterilization, Zenith Contract Services, Representative, Engineering, Orthopedic surgery, AM, FDA, Applied Engineering, 3D printing, Medical device, Conference

Key to this partnership are the strengths and industry knowledge of each organization which delivers a seamless, turnkey solution for medical device AM.

Key Points: 
  • Key to this partnership are the strengths and industry knowledge of each organization which delivers a seamless, turnkey solution for medical device AM.
  • "Our partnership with Tecomet, OIC and Precision ADM will yield unparalleled additive manufacturing expertise to help medical device manufacturers navigate the complexities of the regulatory environment while delivering high-quality, reliable products."
  • "Combining the latest additive manufacturing technologies with our precision manufacturing expertise is a further commitment to this growing technology.
  • "We are thrilled to work with advanced manufacturing powerhouses EOS, Tecomet, and Precision ADM to provide end-to-end medical device production to leading OEMs," added Trevor Gascoyne, CEO of OIC.

Applied BioCode Announces the Launch of the Fungal Panel Assay for Research Use

Retrieved on: 
Monday, June 12, 2023
Research, Technology, Infectious Diseases, Other Technology, Other Health, Biotechnology, Pharmaceutical, Health, Science, Other Science, EUA, UDM, Hair, Infection, Bachelor, BMB, Allergy, Workflow, RPP, Culture, SARS-CoV-2, Software, Pneumocystis jirovecii, COVID-19, Eye, Aspergillus, Histoplasma capsulatum, CE marking, PCR, Nomenclature codes, Immunochemistry, Emergency Use Authorization, Federal Food, Drug, and Cosmetic Act, Panel, Coccidioides, RSV, RUO, Patient, Laboratory, Autoimmune disease, Molecular Probes, IVD, Growth, GPP, Immunodeficiency, Diagnosis, FDA, Mucor, Virus, Vaccine, Rhizopus, Applied Spectral Imaging, Rhizomucor, Fusarium, Cunninghamella, Cryptococcus

The Fungal Panel Assay was developed to detect the most common agents of invasive fungal infections (IFIs) particularly in lower respiratory samples.

Key Points: 
  • The Fungal Panel Assay was developed to detect the most common agents of invasive fungal infections (IFIs) particularly in lower respiratory samples.
  • Applied BioCode’s Fungal Panel is intended for research use only and may be used in infectious disease research or pharmaceutical development.
  • “Applied BioCode is thrilled to announce our first release of an RUO panel under our new product strategy.
  • Applied BioCode, Inc. has also been granted an Emergency Use Authorization (EUA) from the U.S. FDA for its BioCode® SARS-CoV-2 Flu Plus Assay ⱡ, BioCode® SARS-CoV-2 Assay*, and an additional EUA for Pooled COVID-19 Testing*.