Perimeter Files FDA PMA Application for its Next-Generation B-Series OCT with ImgAssist AI 2.0
Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTCQX: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, today announced the submission of a Premarket Approval ...
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Sigrid Therapeutics Secures U.S. Market Access for SiPore Technology Following SHINE Prediabetes Study Success
Sigrid Therapeutics (Sigrid) is excited to announce that it has secured U.S. market access for its proprietary SiPore� technology, following the success of the SHINE study, the largest of its kind in ...
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Bioventus Announces Fourth Quarter and Full Year 2024 Financial Results
DURHAM, N.C., March 11, 2025 (GLOBE NEWSWIRE) -- Bioventus Inc. (Nasdaq: BVS) ("Bioventus” or the "Company”), a global leader in innovations for active healing, today announced fourth quarter and full ...
FDA Approves New Prostate Cancer Imaging Agent Gozellix®
Gozellix®, after radiolabeling with 68 Ga, is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive ...
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Scientist whose work led FDA to ban food dye says agency overstated risk
When the FDA announced in January, before President Joe Biden's term ended, that it would ban a dye called red dye No. 3 in food and ingested drugs, the federal agency cited just one 1987 study on ...
FDA Clears Magstim Transcranial Magnetic Stimulation System for U.S. Adolescent Patient Treatment
This FDA clearance for the Magstim Horizon 3.0 and Inspire systems builds on the existing patient TMS clearances for adult patients, making it possible for physicians and nurse practitioners to treat ...
Food Safety News7d
Publisher’s Platform: FDA, CDC where is the transparency?
It is in that vein I call out my friends at the FDA and CDC for closing a romaine lettuce E. coli O157:H7 case without supplying the public – who they are supposed to serve – with information ...
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Senate Democrats press HHS over FDA firings
The senators also drew attention to the user fee system at the FDA, under which Congress authorizes the agency to collect fees from industry that submit applications for review. The user fee ...
Food Safety News3d
A practical guide to building a food safety culture for retail settings
By Laura M. Wildey Kearse The phrase "food safety culture" is everywhere these days, but what does it mean and how can you, a ...
Scientist whose work led FDA to ban food dye says agency overstated risk
When the FDA announced in January, before President Joe Biden's term ended, that it would ban a dye called red dye No. 3 in ...
Rhythm Pharmaceuticals Reacquires Licensing Rights to IMCIVREE® (setmelanotide) in China with Termination of Agreement with RareStone Ltd.
Under the agreement, Rhythm has agreed to repay $6.3 million in cash to RareStone. Rhythm also agreed to return all shares of RareStone that were acquired under the original agreement for no ...
Food Safety News8d
Senate committee advances Makary to become new head of the FDA
Marty Makary is one step closer to becoming the head of the Food and Drug Administration. On March 13, the Senate Health, Education, Labor and Pensions Committee voted to advance Makary’s ...