Federal Food, Drug, and Cosmetic Act

Exo® Introduces a New Age of Ultrasound with Exo Iris™

Retrieved on: 
Tuesday, September 26, 2023
Technology, Medical Devices, Other Technology, Health Technology, Software, Other Health, Hardware, Health, Artificial Intelligence, Federal Food, Drug, and Cosmetic Act, Communication, IPhone, Workflow, Emeritus, Stanford University, Smartphone, ISO, Hospital, Multimedia, VNA, Sale, POCUS, HITRUST, Triage, Patient, Intravenous therapy, Physician, Nursing, Emergency medical technician, Artificial intelligence, Liver, Silicon, Ecosystem, AI, FDA, Bias, Environment, HIPAA, Caregiver, Medical imaging, Telescopic sight, Medical device, Exo, Iris

Exo (pronounced “echo”), a medical imaging software and device company, today unveiled a category-redefining handheld ultrasound device, Exo Iris™ , to put high-performance medical imaging into the hands—and pockets—of every caregiver.

Key Points: 
  • Exo (pronounced “echo”), a medical imaging software and device company, today unveiled a category-redefining handheld ultrasound device, Exo Iris™ , to put high-performance medical imaging into the hands—and pockets—of every caregiver.
  • Built on Exo’s advanced silicon technology, Exo Iris delivers versatile imaging performance for point-of-care ultrasound (POCUS) at a fraction of the size and cost of cart-based systems.
  • View the full release here: https://www.businesswire.com/news/home/20230926600687/en/
    A New Age of Ultrasound: Exo Iris (Graphic: Business Wire)
    “Iris represents a new era of ultrasound,” said Sandeep Akkaraju, CEO and Co-Founder of Exo.
  • Exo Iris comes equipped with Exo’s point-of-care ultrasound workflow solution, Exo Works™ , to seamlessly document and review exams in seconds from anywhere.

Natural Cycles receives FDA Clearance to integrate its birth control app with data measured by Apple Watch

Retrieved on: 
Tuesday, September 19, 2023
Pregnancy, Apple Watch, Wrist, Natural Cycles, Health, Cycle track, Oura Health, Washington Apple Health, Woman, Temperature, FACOG, Hormone, Federal Food, Drug, and Cosmetic Act, Thermoregulation, MD, Love, Oura, Apple, Health (Apple), FDA, Regulation of tobacco by the U.S. Food and Drug Administration, FD, Food, Medical device, Mobile phone

NEW YORK, Sept. 19, 2023 /PRNewswire/ -- Natural Cycles, the company that developed the world's first birth control app, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its use of wrist temperature data from Apple Watch. The integration will allow the Natural Cycles app, an FDA Cleared Class II medical device in the U.S., to use overnight wrist temperature data from Apple Watch (Series 8 and later and all models of Apple Watch Ultra) for users consenting to share this information. The integration has also been cleared by regulators in Europe and has been registered for use in Australia.

Key Points: 
  • The NC° app, an FDA Cleared Class II medical device, will now sync wrist temperature data from Apple Watch.
  • In September 2022, Apple introduced temperature-sensing capabilities to Apple Watch with the release of Apple Watch Series 8 and Apple Watch Ultra.
  • This latest 510(k) clearance uses Apple Watch wrist temperature data, clearing the app to work with the Apple Watch in the U.S.
  • Users must explicitly choose to share overnight wrist temperature data measured by Apple Watch from the Apple Health app with the Natural Cycles app and can manage permissions at any time.

ISPE Unveils First of Its Kind Guidance Document and Launches New Community of Practice on Pharmaceutical Compounding

Retrieved on: 
Tuesday, September 19, 2023
NORTH, ISPE, CGMP, Pharmacy, Community of practice, Medication, Federal Food, Drug, and Cosmetic Act, Thought, CGMP-specific phosphodiesterase type 5, Patient, Guide, Compounding, Knowledge, FDA, FD, International Society, Food, Pharmaceutical industry, Internet service provider, Medical device

NORTH BETHESDA, Md., Sept. 19, 2023 /PRNewswire-PRWeb/ -- The International Society for Pharmaceutical Engineering (ISPE) is proud to introduce two significant initiatives aimed at benefitting the field of pharmaceutical compounding—the release of the "ISPE Guide: 503B Compounding – Regulatory Basis and Industry Good Practices for Outsourcing Facilities" and the launch of the ISPE Community of Practice (CoP) on Pharmaceutical Compounding.

Key Points: 
  • ISPE is proud to provide critical guidance to the pharmaceutical compounding industry with the release of the "ISPE Guide: 503B Compounding – Regulatory Basis and Industry Good Practices for Outsourcing Facilities" and the launch of the ISPE CoP on Pharmaceutical Compounding.
  • Recognizing the pressing need for best practice sharing, training, and guidance for creative problem solving in compounding pharmacies, ISPE launched a new ISPE Community of Practice (CoP) on Pharmaceutical Compounding.
  • "ISPE is proud to provide critical guidance to the pharmaceutical compounding industry with the release of the "ISPE Guide: 503B Compounding – Regulatory Basis and Industry Good Practices for Outsourcing Facilities" and the launch of the ISPE CoP on Pharmaceutical Compounding," said Tom Hartman, ISPE President & CEO.
  • We believe these initiatives will play a pivotal role in shaping the future of pharmaceutical compounding, ultimately benefitting patients and communities worldwide."

Positron Corporation Announces Start of Clinical Study of Affinity PET-CT Device

Retrieved on: 
Friday, September 8, 2023
Ochsner Health System, Institutional review board, Federal Food, Drug, and Cosmetic Act, Investigational device exemption, POSC, International Committee for the Nanking Safety Zone, Molecular imaging, Positron Corporation, Trial of the century, Register, Documentation, Patient, Physician, OTC, Affinity, FDA, Medical imaging, Positron

Niagara Falls, NY, Sept. 08, 2023 (GLOBE NEWSWIRE) -- Positron Corporation (“Positron” or the “Company”) (OTC: POSC), a leading molecular imaging medical device company, is pleased to announce that the Company will begin its clinical study of its Affinity™ PET-CT imaging device with Ochsner Clinic Foundation in New Orleans, LA.

Key Points: 
  • Niagara Falls, NY, Sept. 08, 2023 (GLOBE NEWSWIRE) -- Positron Corporation (“Positron” or the “Company”) (OTC: POSC), a leading molecular imaging medical device company, is pleased to announce that the Company will begin its clinical study of its Affinity™ PET-CT imaging device with Ochsner Clinic Foundation in New Orleans, LA.
  • The objective of the clinical study is to obtain key data that will represent the performance and efficacy of Positron’s new state-of-the-art PET-CT imaging device.
  • The initial phase of the clinical study will consist of phantom testing and subsequent imaging of human patients once Positron receives its Investigational Device Exemption from the FDA.
  • In parallel with the clinical study Positron will submit its 510k and Registration to the FDA for clearance to market and sell the Affinity PET-CT.

Stryker’s Pangea Systems Receive FDA Clearance

Retrieved on: 
Tuesday, September 12, 2023
Medical Devices, Surgery, Hospitals, FDA, Health Technology, Biotechnology, Physical Therapy, Health, Science, Other Science, Federal Food, Drug, and Cosmetic Act, Surgeon, SYK, Utility, Trauma, Pangaea, Fracture, Fibula, Femur, NYSE, Dentistry, Humerus, Tibia

Stryker (NYSE: SYK), one of the world’s leading medical technology companies, announced that its Pangea Systems including Femur, Fibula, Tibia, Humerus and Utility have received 510k clearance from the U.S. Food & Drug Administration.

Key Points: 
  • Stryker (NYSE: SYK), one of the world’s leading medical technology companies, announced that its Pangea Systems including Femur, Fibula, Tibia, Humerus and Utility have received 510k clearance from the U.S. Food & Drug Administration.
  • “FDA clearance is a critical milestone for our Pangea Systems,” said Eric Tamweber, Vice President and General Manager, Stryker’s Trauma business unit.
  • “With these new systems, we are now offering surgeons a comprehensive portfolio that supports a wide range of their trauma needs.”
    Designed by the collaborative efforts of world-renowned orthopaedic surgeons, the Pangea plates offer an evidence-based design for implant fit.
  • The Pangea Systems will be featured at the Annual Orthopaedic Trauma Association meeting (booth #505) in Seattle on Oct. 18-21.

THC edibles that look like snacks popular with kids? FTC and FDA have something to say about that.

Retrieved on: 
Tuesday, August 29, 2023
Smoke, Edible, Hatred, Male, Advertising, Federal Trade Commission Act of 1914, Marketing, Federal Trade Commission, Policy, Record, Sour Patch Kids, Blog, Privacy, Sale, Moon, Government, Federal Food, Drug, and Cosmetic Act, Chemistry, Candy, Cheetos, Social Security, Risk, FTC, Child, Comment, Cannabis, Social, Health, FDA, Fraud, THC, Heck, LLC, Deception, Safety, Dietary supplement, Kansas City metropolitan area

THC edibles that look like snacks popular with kids? FTC and FDA have something to say about that.According to the two agencies, the companies currently market edibles containing Delta-8 THC (yeah, that THC) with packaging and advertising that mimic the look of candy and snack brands popular with children.

Key Points: 

THC edibles that look like snacks popular with kids? FTC and FDA have something to say about that.

    • According to the two agencies, the companies currently market edibles containing Delta-8 THC (yeah, that THC) with packaging and advertising that mimic the look of candy and snack brands popular with children.
    • Delta-8 THC is a component of cannabis with similar psychoactive and intoxicating effects as Delta-9 THC – the substance responsible for the high people get from cannabis.
    • In June 2022, FDA issued a warning about the health risks to children of ingesting foods containing THC.
    • FDA’s concern isn’t hypothetical, with numerous poison control calls and adverse event reports stemming from kids’ eating THC-laced products by accident.
    • Some of the reports specifically mentioned that the edible was a copycat of a brand-name food.

Cybeats Signs Three Year, Seven Figure Contract with Global Top 5 Medical Device Leader

Retrieved on: 
Tuesday, August 29, 2023
Regulation of tobacco by the U.S. Food and Drug Administration, CSE, Medical device, CYBT, RTA, Omnibus spending bill, Risk assessment, SBOM, Consolidated Appropriations Act, 2016, Orgasmatron (massage device), Omnibus, Federal Food, Drug, and Cosmetic Act, MDM, FDA, FD, Food

Rapid healthcare cybersecurity  growth has been fueled by the amended FD&C Act's section 524B - 'Ensuring Cybersecurity of Medical Devices' from earlier this year.

Key Points: 
  • Rapid healthcare cybersecurity  growth has been fueled by the amended FD&C Act's section 524B - 'Ensuring Cybersecurity of Medical Devices' from earlier this year.
  • This contract, along with several recent wins from the medical device sector, underscores the Company's growing expertise in the healthcare industry and increasing demand for effective SBOM management.
  • To proactively manage cybersecurity risks, MDMs must maintain an accurate inventory of device components, develop vulnerability management and risk assessment processes, provide device patches, and maintain device change records.
  • The urgent need for managing vast amounts of SBOM data has created a large and growing addressable market for solutions like SBOM Studio.

Cingulate Inc. Reports Second Quarter 2023 Financial Results and Provides Clinical and Business Update

Retrieved on: 
Monday, August 14, 2023
Insurance, Cingulata, Research and development, Doctor of Pharmacy, Anxiety, Dextroamphetamine, Policy, New Drug Application, ADHD, NDA, WFIA, G&A, Research, Meta-analysis, Faraone, Federal Food, Drug, and Cosmetic Act, Market, Buspirone, Patient, Administration, Associate, Adolescence, R, FDA, IND, Precision Time Protocol Industry Profile, Safety, Dietary supplement, Pharmaceutical industry, Rare-earth element, Cryptocurrency

KANSAS CITY, Kan., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING) (Cingulate or the Company), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today provided financial results for the quarter ended June 30, 2023, as well as a clinical and business update. Among other highlights, the Company announced a $1 million dollar investment from Werth Family Investment Associates LLC (WFIA), top-line results following the completion of a Phase 3 Adult Efficacy and Safety Trial of CTx-1301, and the initiation of the CTx-1301 Phase 3 pediatric and adolescent studies.

Key Points: 
  • CTx-1301: Cingulate advanced its clinical program for CTx-1301 on the streamlined approval pathway under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.
  • As part of that effort:
    Cingulate completed a Phase 3 adult dose-optimization study in June 2023 and announced top-line results in July 2023.
  • Assuming positive clinical results from the upcoming Phase 3 trials, Cingulate plans to submit a New Drug Application (NDA) for CTx-1301 in the second half of 2024 under the Section 505(b)(2) pathway.
  • Cingulate expects its cash and cash equivalents will enable the Company to fund its research and development and operating expenditures into September 2023.

Nexus Pharmaceuticals Receives FDA Approval for Potassium Chloride for Injection Concentrate, USP

Retrieved on: 
Tuesday, August 15, 2023
Other Manufacturing, FDA, Manufacturing, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, CGT, Hospira, Food and Drug Administration, USP, RLD, Federal Food, Drug, and Cosmetic Act, Potassium chloride, FD, Food, Pharmaceutical industry, Nexus

Nexus Pharmaceuticals announced it has received U.S. Food and Drug Administration (FDA) approval for Potassium Chloride for Injection Concentrate, USP in 10mL and 20mL Single-Dose Vials.

Key Points: 
  • Nexus Pharmaceuticals announced it has received U.S. Food and Drug Administration (FDA) approval for Potassium Chloride for Injection Concentrate, USP in 10mL and 20mL Single-Dose Vials.
  • According to the FDA and the FD&C (Federal Food, Drug, and Cosmetic) Act, the product is considered bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Potassium Chloride for Injection Concentrate, USP, of Hospira, Inc.
  • “This approval highlights Nexus’ commitment to stabilizing the domestic pharmaceutical supply chain,” said Usman Ahmed, President and CEO of Nexus.
  • “Potassium Chloride for Injection Concentrate has been on the FDA’s drug shortage list for several years and we are very proud to alleviate this shortage with a product manufactured in the United States.

Medcrypt and Tidelift Partner to Empower Medical Device Manufacturers with Open Source Software Data and Software Bill of Materials Analysis

Retrieved on: 
Tuesday, August 15, 2023
Partnership, Helm, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SBOM, Federal Food, Drug, and Cosmetic Act, Triage, SAN, FDA, MDM, Food, Risk management, Medical device

SAN DIEGO, Aug. 15, 2023 /PRNewswire/ -- Medcrypt, Inc., the proactive cybersecurity solution provider for medical device manufacturers (MDMs), today announced its partnership with Tidelift, a provider of solutions for improving the security and resilience of the open-source software powering modern applications. This partnership will strengthen medical device security by leveraging data to offer advanced security solutions to customers, ensuring devices stay safe throughout their entire lifecycle.

Key Points: 
  • This partnership will strengthen medical device security by leveraging data to offer advanced security solutions to customers, ensuring devices stay safe throughout their entire lifecycle.
  • By leveraging Tidelift's data, Medcrypt advances its Helm solution; this partnership expands the data provided to customers, making a significant impact on post-market vigilance.
  • "We understand the urgency facing medical device manufacturers in meeting the FDA deadline," said Om Mahida , VP of Product at Medcrypt.
  • Join Medcrypt and Tidelift for a webinar on August 22, 2023 , where they will dive into how this collaboration enhances security through SBOM and vulnerability management.