Federal Food, Drug, and Cosmetic Act

Cybeats Highlights Favorable U.S. Cyber Policy, Executive Orders and Industry Advancement; White House Features Cybeats in Recent Release

Retrieved on: 
Tuesday, November 7, 2023
Internet of things, FDA, Nation, Policy, Food, NIST, Medical device, White House, Life, MDM, Executive order, Regulation of tobacco by the U.S. Food and Drug Administration, Federal Food, Drug, and Cosmetic Act, Administration, CSE, Artificial intelligence, CYBT, ETSI, FD, Ecosystem, Risk assessment, White, RTA, Privacy, Federal, Safety, AI, CISA, SBOM, EU

A U.S. White House statement released on October 31, 2023 followed a White House Executive Order on artificial intelligence ("AI"), that included novel software inventory requirements on AI.

Key Points: 
  • A U.S. White House statement released on October 31, 2023 followed a White House Executive Order on artificial intelligence ("AI"), that included novel software inventory requirements on AI.
  • This statement featured Cybeats as part of an innovative industry coalition in support of the White House on this new AI Executive order.1
    "At Cybeats, we've been dedicated to creating a solution for companies to manage the economic and security challenges of adopting SBOMs," said Dmitry Raidman, CTO, Cybeats.
  • "From the early days of our involvement with shaping SBOM standards, to now leading the SBOM management market, we're quite proud.
  • The FDA's Refuse-to-Accept ("RTA") authority as of March 29, 2023 emphasizes the significance of SBOM management solutions like SBOM Studio.

BioXcel Therapeutics Announces Update on NIDA-funded Trial of BXCL501 (sublingual dexmedetomidine) for Potential Treatment of Opioid Use Disorder (OUD)

Retrieved on: 
Monday, November 6, 2023
Post-traumatic stress disorder, FDA, Yale School of Medicine, Opioid use disorder, Standard of care, Intelligence, Government, Public Health Service Act, White House, Dexmedetomidine, Opioid epidemic, BID, Federal Food, Drug, and Cosmetic Act, Federation, Addiction, Xylazine, Psychiatry, COWS, Recreational drug use in Kenya, Locus coeruleus, Pharmacokinetics, OUD, National Institute on Drug Abuse, NIDA, Columbia University, NIH, Safety, Public, American Journal, Minneapolis Veterans Affairs Health Care System, Therapy, Office of Inspector General, U.S. Department of Health and Human Services, Patient, Fentanyl, Bangladesh Technical Education Board, RTI International, United States Public Health Service, Pharmaceutical industry, Neuroscience

NEW HAVEN, Conn., Nov. 06, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced an update on the National Institute on Drug Abuse (NIDA)-funded trial evaluating BXCL501 (sublingual dexmedetomidine) as a potential treatment for opioid use disorder (OUD).

Key Points: 
  • NIDA has requested Columbia University, the trial coordinator, to add a fourth site to target trial completion in 2024.
  • After this time, BioXcel Therapeutics plans to seek FDA feedback on potential registrational paths.
  • “With BXCL501, we are excited about the potential to treat patients who are physically dependent on illicit and prescription opioids.
  • In addition to OUD as an indication, BioXcel Therapeutics has been awarded key opportunities for the development of BXCL501 in post-traumatic stress disorder and alcohol use disorder.

NRx Pharmaceuticals Announces Signing of a Development Agreement for the Manufacture of Ketamine to Treat Suicidality and Depression

Retrieved on: 
Tuesday, October 31, 2023
FDA, Dark Enlightenment, Cosmetics, Food, JD, Suicide, Compound, Federal Food, Drug, and Cosmetic Act, Pharmacy, Depression, Patient, Pharmaceutical industry, Ketamine

Existing supplies of Ketamine are not labeled for treatment of depression and suicidality and often do not conform to modern manufacturing requirements for single-dose injectable medications.

Key Points: 
  • Existing supplies of Ketamine are not labeled for treatment of depression and suicidality and often do not conform to modern manufacturing requirements for single-dose injectable medications.
  • NRx and its manufacturing partner plan to release further information in an upcoming 8K filing.
  • As intravenous Ketamine becomes more widely used to treat depression and suicidality, the supply of Ketamine – which today is approved only for use as an anesthetic – becomes increasingly tenuous.
  • We and our partner look forward to sharing further information as the manufacturing, regulatory, and business plans are finalized," said Stephen Willard, JD, CEO of NRx Pharmaceuticals.

Riverpoint Medical Receives FDA Approvals for OC Coating Technology of Textile and Fiber

Retrieved on: 
Thursday, October 26, 2023
OC, FDA, Medicine, Federal Food, Drug, and Cosmetic Act, Patient, AAOS, Pharmaceutical industry, Medical device

PORTLAND, Ore., Oct. 26, 2023 /PRNewswire-PRWeb/ -- Riverpoint Medical is thrilled to announce its success in securing its first FDA 510k's for OC Coating Technology.

Key Points: 
  • Riverpoint Medical is thrilled to announce its success in securing its first FDA 510k's for OC Coating Technology.
  • PORTLAND, Ore., Oct. 26, 2023 /PRNewswire-PRWeb/ -- Riverpoint Medical is thrilled to announce its success in securing its first FDA 510k's for OC Coating Technology.
  • Riverpoint Medical's proprietary coating technology integrates osteoconductive bioceramic materials into the surface of the medical textile, offering a revolutionary biological solution for various medical devices.
  • Doug King, CEO of Riverpoint Medical, stated, "This marks another pivotal step for Riverpoint Medical in delivering novel solutions to advance the quality of medical devices for our partners and patients.

ZEISS continues to expand its clinical workflows and digital portfolio, presenting new tools and solutions at AAO 2023

Retrieved on: 
Thursday, October 26, 2023
Social media, Food, True color, Eye, Software, American Academy, GA, Epiretinal membrane, AI, AMD, AAO, Diabetic retinopathy, Workflow, Ecosystem, Marketing, American Academy of Ophthalmology, Macular edema, OCT, Patient, Food and Drug Administration Amendments Act of 2007, Geographic atrophy, Connectivity, Laser, Capsulotomy, FDA, Federal Food, Drug, and Cosmetic Act, DR, IOL, Multimedia, Surgeon, Cataract, Telescopic sight, Fused quartz, Medical device, Medical imaging, Online shopping, ZEISS, Retina

New ZEISS PROSPARA digital marketing software within the ZEISS Corneal Refractive Workflow helps enhance online visibility for refractive practices.

Key Points: 
  • New ZEISS PROSPARA digital marketing software within the ZEISS Corneal Refractive Workflow helps enhance online visibility for refractive practices.
  • ZEISS VISULAS yag therapeutic laser receives 510k clearance in the US, expanding offerings within the ZEISS Cataract Workflow.
  • As part of the ZEISS Medical Ecosystem , these innovations offer new digital tools to help advance clinical and patient management to a higher level of efficient and personalized care.
  • ZEISS PROSPARA is set to launch at AAO this year, with more information becoming available in November 2023.

ZEISS continues to expand its clinical workflows and digital portfolio, presenting new tools and solutions at AAO 2023

Retrieved on: 
Thursday, October 26, 2023
Social media, Food, True color, Eye, Software, American Academy, GA, Epiretinal membrane, AI, AMD, AAO, Diabetic retinopathy, Workflow, Ecosystem, Marketing, American Academy of Ophthalmology, Macular edema, OCT, Patient, Food and Drug Administration Amendments Act of 2007, Geographic atrophy, Connectivity, Laser, Capsulotomy, FDA, Federal Food, Drug, and Cosmetic Act, DR, IOL, Surgeon, Cataract, Telescopic sight, Fused quartz, Medical device, Medical imaging, ZEISS, Retina

New ZEISS PROSPARA digital marketing software within the ZEISS Corneal Refractive Workflow helps enhance online visibility for refractive practices.

Key Points: 
  • New ZEISS PROSPARA digital marketing software within the ZEISS Corneal Refractive Workflow helps enhance online visibility for refractive practices.
  • ZEISS VISULAS yag therapeutic laser receives 510k clearance in the US, expanding offerings within the ZEISS Cataract Workflow.
  • As part of the ZEISS Medical Ecosystem , these innovations offer new digital tools to help advance clinical and patient management to a higher level of efficient and personalized care.
  • ZEISS PROSPARA is set to launch at AAO this year, with more information becoming available in November 2023.

Orthofix Announces 510k Clearance and Full Commercial Launch of OsteoCove, an Advanced Bioactive Synthetic Graft for use in Spine and Orthopedic Procedures

Retrieved on: 
Thursday, October 12, 2023
Medical Devices, FDA, Health, Other Health, Physical Therapy, Biotechnology, Surgeon, Multimedia, Growth, DBM, Federal Food, Drug, and Cosmetic Act, Spine, Osteon, Ceramic

Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the 510k clearance and full commercial launch of OsteoCove™, an advanced bioactive synthetic graft.

Key Points: 
  • Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the 510k clearance and full commercial launch of OsteoCove™, an advanced bioactive synthetic graft.
  • Available in both a putty and strip configuration, OsteoCove was carefully formulated to provide superior bone-forming capabilities with best-in-class handling characteristics for a wide range of spine and orthopedic procedural applications.
  • This press release features multimedia.
  • View the full release here: https://www.businesswire.com/news/home/20231012672479/en/
    Image of OsteoCove putty and strip, an advanced bioactive synthetic graft formulated to provide superior bone-forming capabilities with best-in-class handling characteristics for a wide range of spine and orthopedic procedural applications.

PathKeeper Surgical Demonstrates New Technology at Prestigious North American Spine Society Annual Meeting

Retrieved on: 
Thursday, October 12, 2023
Health, KFAR, North American Spine Society, NASS, Radiation, Spine, FDA, Federal Food, Drug, and Cosmetic Act, Surgeon, Operating, Medical imaging

KFAR SABA, Israel, Oct. 12, 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, today announces its participation in the upcoming North American Spine Society (NASS) 2023 Annual Meeting at the Los Angeles Convention Center, Los Angeles, CA, from October 18 to 20, 2023.

Key Points: 
  • The PathKeeper 3D Optical Navigation System aims to improve clinical experience and reduce the reliance on radiation in spine surgery.
  • The PathKeeper System was designed to replace traditional navigation technology with an active, independent and precise 3D optical navigation system.
  • "The United States represents a strategically important market for commercializing the PathKeeper System and the NASS annual meeting is the ideal environment to demonstrate our technology to spine surgeons from the United States and around the world," said Erez Lampert, Chief Executive Officer and Founder of PathKeeper Surgical.
  • PathKeeper Surgical received its FDA 510k clearance earlier this year for the PathKeeper System.

Trinity Biotech Announces Q2 2023 Financial Results

Retrieved on: 
Tuesday, October 3, 2023
KPI, Clinical chemistry, Federal Food, Drug, and Cosmetic Act, Partnership, Q3, SG, HIV, Diagnosis of HIV/AIDS, Reference, Balance sheet, Ion exchange, U.S. FDA, Mayo Clinic Center for Innovation, Ministry, A1C, EBITDA, Traction, Autoimmune disease, Supply chain, Investment, World Health Organization, Ministry of Health (Kuwait), Units of paper quantity, Growth, FDA, Calibration, Glycated hemoglobin, Pharmaceutical industry, Beauty salon, Fine chemical, Retail, Medical device, Video game, Vaccine, Renewable energy, Creative industries, Bank, Quest, Q2, Finance, Health, Sjögren syndrome, Diabetes

DUBLIN, Ireland, Oct. 03, 2023 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB), a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, today announced the Company’s results for the quarter ended June 30, 2023.

Key Points: 
  • DUBLIN, Ireland, Oct. 03, 2023 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB), a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, today announced the Company’s results for the quarter ended June 30, 2023.
  • Total revenue for fiscal Q2, 2023 was $13.9m (excluding Fitzgerald Industries, which was disposed of in April 2023).
  • In August, Trinity Biotech received U.S. FDA 510(k) clearance for the Premier Resolution System, the automated analyzer for accurate & precise quantification of haemoglobin variants.
  • Total revenues for Q2, 2023 were $13.9m which compares to $15.4m in Q2, 2022, a decrease of 9.8% and which were broken down as follows:

Signati™ Medical Files IDE Study with FDA

Retrieved on: 
Tuesday, September 26, 2023
Trial of the century, Federal Food, Drug, and Cosmetic Act, Medicine, IDE, FDA, SVP, FD, Food, Safety, Wound healing, Medical device, Birth control

Providence, RI, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Signati™ Medical has officially filed their IDE study with the FDA.

Key Points: 
  • Providence, RI, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Signati™ Medical has officially filed their IDE study with the FDA.
  • An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data.
  • All clinical evaluations of investigational devices must have an approved IDE before the study begins.
  • The IDE study will be the final step for Signati™ to market their Sealed Vasectomy Procedure (SVP)™ to the public once fully approved by the FDA.