Friday, 01 December 2023
The News and Media Division of The Insight Partners

Zebra Medical Vision Secures FDA Clearance in Oncology

Zebra Medical Vision, the deep-learning medical imaging analytics company, announced today its sixth FDA 510(k) clearance for its mammography solution, HealthMammo, which has already received a CE mark. Zebra Medical’s algorithm empowers breast radiologists by pri..

Monday, 27 Jul 2020

Ascend to Perform Antibody Testing for COVID-19

Ascend, the dialysis testing laboratory, has begun performing antibody testing for COVID-19. Ascend is one of the first to offer COVID-19 total antibody testing on the Siemens high throughput platform, which can be combined with a patient's regularly scheduled ..

Tuesday, 02 Jun 2020

Hikma launches Dicyclomine Hydrochloride Oral Solution

Hikma Pharmaceuticals PLC (Hikma), the multinational generic pharmaceutical company, has launched Dicyclomine Hydrochloride Oral Solution, USP, 10 mg/5 mL, an AA-rated version of Bentyl®1 Oral Syrup, 10 mg/5 mL in the United States through its US affiliate, Hi..

Thursday, 28 May 2020

Hikma receives FDA approval for its generic Vascepa®

Hikma Pharmaceuticals PLC (Hikma), the multinational generic pharmaceutical company, has announced that its wholly owned U.S. subsidiary Hikma Pharmaceuticals USA Inc. has received approval from the US Food and Drug Administration (FDA) for its Icosapent Ethyl Cap..

Friday, 22 May 2020

FDA suspending routine food facility inspections

The Food and Drug Administration is suspending “routine” food facility inspections in an effort to ensure the safety of its workforce and not interfere with food manufacturer programs to limit the number of visitors to their facilities in the wake of the coronavi..

Friday, 20 Mar 2020

First AI Product Cleared for MRI Image Enhancement by FDA

Subtle Medical, a healthcare technology company focused on improving the quality, efficiency, and accessibility of medical imaging, announced today 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market SubtleMRTM. SubtleMR is an image processing..

Wednesday, 16 Oct 2019

Primary Practicability Trial announced by Medtronic

Medtronic plc recently publicizes the news for their acceptance received form the U.S. Food and Drug Administration (FDA) for initiating a primary feasibility study (EFS) for their Intrepid™ transcatheter mitral valve replacement (TMVR) system making use of a marg..

Monday, 07 Oct 2019

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Smart Market News is committed to getting its readers the latest updates and insights on industries that help in making “smarter” business decisions. With insights and inputs from corporate decision makers, we bring you the stories of adopting innovative solutions and strategies that have been changing the world. Our editorial insights on products, solutions, companies, and adoption of best practices not only help in understanding the markets better, but also prove to be a complete package for your information needs.

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