PULSE BIOSCIENCES: Provides Update on FDA 510(k) Submission for the CellFX System in Dermatology
Schedules Business Update Call on February 18, 2020 at 2:00pm PT
Latest News
SOLITON: Files Special 510(k) with FDA for its Generation II RAP Device
Soliton, Inc., (Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center ("MD Anderson"), today announced that it has filed for Special 510(k) Premarket Notification with the U.S. Food and Drug Administration ("FDA") for its Generation II Rapid Acoustic Pulse ("RAP") device.
GOJO: Takes Immediate Action on Communication from the FDA
GOJO took immediate action to respond to FDA claim requirements after receiving a warning letter from the agency on January 17.
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AAO: Reports Congressmen Write Letter to the FDA and FTC Regarding SmileDirectClub, While California Board of Dentistry Moves to Dismiss SmileDirectClub's Lawsuit
The American Association of Orthodontists (AAO) - in the interests of the health, safety, and well-being of patients seeking orthodontic care - reports that on January 6, nine members of the U.S. House of Representatives authored a letter to the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) "to express [their] concern regarding SmileDirectClub."
MOST SACRED HEART OF JESUS CARDIOLOGY AND VALVULAR INSTITUTE: Dr. Rajamannan Sends Over to the FDA Commissioner the US Senate Finance Investigation Files to Help the FDA's Review of Newly Discovered Design Control Study in Chicago
Minneapolis FDA delays reporting to the patients in Chicago the non-exempt testing of the device affecting 667 patients
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U.S. FDA: Michigan-based food manufacturer agrees to stop production after repeated food safety violations
U.S. District Judge Sean F. Cox entered a consent decree of permanent injunction between the U.S. and Home Style Foods, Inc., and the company’s owner, Michael J. Kowalski, and quality manager, Juan Valesquez. Home Style Foods, Inc., a Michigan-based food manufacturer, has agreed to discontinue selling food products until the company complies with federal regulations and other requirements.
SURGLASSES: Foresee-X Augment Reality Solution from SURGLASSES Is Registered with the FDA and Ready for Trauma Treatment
Foresee-X is a set of smart surgical glasses with functionality based on augmented and mixed reality technologies.
CORREVIO: Receives Complete Response Letter From U.S. FDA for Brinavess and Provides Update on Recent Events
Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Brinavess™ (vernakalant IV), an anti-arrhythmic drug for the conversion of atrial fibrillation (AF).
JANSSEN PHARMACEUTICAL COMPANIES OF JOHNSON & JOHNSON: Complete Response Letter Issued from U.S. FDA for Investigational Long-Acting HIV Regimen
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) in response to ViiV Healthcare's (ViiV) New Drug Application for the two-drug long-acting (LA) injectable regimen of ViiV's cabotegravir and Janssen's rilpivirine for the treatment of HIV-1 infection in adults. The regimen was co-developed as part of a collaboration between Janssen and ViiV.
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VIIV HEALTHCARE: Receives complete response letter from US FDA for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its application for cabotegravir and rilpivirine long-acting regimen for treatment of HIV-1 infection in virologically suppressed adults.
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U.S. FDA: FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA bacteria
Today, the U.S. Food and Drug Administration authorized marketing of a new diagnostic test based on bacterial viability and novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization, a widespread cause of hospital-acquired infections.
U.S. FDA: FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health
Clinic had significant donor eligibility violations, including donor screening and testing
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U.S. FDA: California-based food manufacturer agrees to stop production after repeated food safety violations
The U.S. Food and Drug Administration announced that recently Golden Gate Soy Products, a California-based food manufacturer, has agreed to discontinue selling food products until the company complies with federal regulations and other requirements.
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U.S. FDA: FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns
Violations include marketing unapproved new human and animal drugs, selling CBD products as dietary supplements, and adding CBD to human, animal foods
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U.S. FDA: Statement on new steps to advance innovation in medical device sterilization with ethylene oxide
At the U.S. Food and Drug Administration we continue to closely monitor the supply chain effects of closures and potential closures of specific large-scale sterilization facilities that use a gas called ethylene oxide to sterilize certain medical devices prior to their use.
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IRRAS: Announces FDA Clearance of New 510(K) Filing to Expand the Time of Use of IRRAflow®
IRRAS, a global healthcare company with a comprehensive portfolio of innovative products for neurocritical care, announced today that the US FDA has cleared a new 510(K) for IRRAflow.