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RSS FeedPosted by Michael Wonder on 19 Apr 2022
iHealthScreen announces TGA approval for iPredict automated AI system for early diagnosis of diabetic retinopathy, age-related macular degeneration and glaucoma suspect
19 April 2022 - iHealthScreen is the first company in the USA to receive a CE certification, Australian Health approval, and ...
Posted by Michael Wonder on 05 Apr 2022
Curium announces FDA approval of a generic version of DaTscan (Ioflupane I 123 injection) in the U.S.
5 April 2022 - Curium announced today that its generic version of DaTscan (Ioflupane I 123 injection) was approved on 30 ...
Posted by Michael Wonder on 31 Mar 2022
New drug application resubmission
31 March 2022 - NDA submission for Polarean’s hyperpolarised 129Xenon gas drug device combination product ...
Posted by Michael Wonder on 29 Mar 2022
Gadopiclenol marketing authorisation dossier submissions accepted for review by EMA and FDA
29 March 2022 - Priority review granted by U.S. FDA. ...
Posted by Michael Wonder on 23 Feb 2022
Theragnostics announces US FDA approval for its radiodiagnostic imaging drug NephroScan (kit for the preparation of Technetium Tc 99m succimer injection)
23 February 2022 - NephroScan is now U.S. FDA approved for the preparation of Tc-99m DMSA. ...
Posted by Michael Wonder on 21 Feb 2022
U.S. FDA approves FoundationOne CDx as a companion diagnostic for Keytruda (pembrolizumab) to identify patients with microsatellite instability-high solid tumours
21 February 2022 - Foundation Medicine’s tissue-based comprehensive genomic profiling test is now the first and only FDA approved companion diagnostic ...
Posted by Michael Wonder on 16 Feb 2022
GE Healthcare's stress agent Rapiscan approved for use in stress cardiac magnetic resonance imaging
14 February 2022 - Already used in single photon emission computed tomography (SPECT) myocardial perfusion imaging for adult patients, Rapiscan is ...
Posted by Michael Wonder on 14 Feb 2022
US FDA grants the coveted breakthrough designation for early stage prostate cancer detection blood test developed in India by Datar Cancer Genetics
14 February 2022 - It is the first blood test able to detect early stage prostate cancer with high accuracy ...
Posted by Michael Wonder on 04 Feb 2022
Biden-Harris Administration will cover free over the counter COVID-19 tests through Medicare
3 February 2022 - As part of the Biden-Harris Administration’s ongoing efforts to expand Americans’ access to free testing, people in ...
Posted by Michael Wonder on 02 Feb 2022
Biden promised 500 million free Covid tests. Then he had to find them.
2 February 2022 - Millions of Americans are now receiving tests through the new mail program, which health experts said came ...
Posted by Michael Wonder on 23 Jan 2022
Pharmacists struggle to meet demand for free COVID test kits amid stock shortage
23 January 2022 - Chemists across the country say they do not have enough rapid antigen tests to start handing ...
Posted by Michael Wonder on 18 Jan 2022
TGA ‘knowingly putting pharmacists in serious danger’
18 January 2022 - The pharmacists’ union has accused the medical regulator of putting workers and customers at risk of ...
Posted by Michael Wonder on 12 Jan 2022
Biden-Harris Administration requires insurance companies and group health plans to cover the cost of at home COVID-19 tests, increasing access to free tests
10 January 2022 - As part of its on-going efforts across many channels to expand Americans’ access to free testing, the ...
Posted by Michael Wonder on 19 Dec 2021
FDA approves Telix’s prostate cancer imaging product, Illuccix
19 December 2021 - Telix Pharmaceuticals today announces that the United States FDA has approved Telix’s lead prostate cancer imaging product, ...
Posted by Michael Wonder on 12 Dec 2021
FDA approves NGS based companion diagnostic for EGFR exon20 insertion mutant non-small-cell lung cancer tumour tissue
9 December 2021 - Oncomine Dx Target Test now approved for 12 NSCLC targeted therapies globally. ...