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Wavegate Corporation | January 14, 2022
Wavegate Corporation announced that the U.S. Food and Drug Administration has granted Breakthrough Device designation for its StimuLux™ optical reflectometry system for closed-loop adaptive modulation of spinal cord stimulation. The FDA's Breakthrough Device designation is designed to expedite the development and regulatory review of medical devices that are intended to treat serious or life-threatening diseases. To qualify for this designation, preliminary evidence must demonstrate a ...
BUSINESS INSIGHTS, PHARMACY MARKET
Envision Pharma Group | February 10, 2023
Envision Pharma Group (Envision), a leading evidence-based communication services and industry-leading technology solutions provider serving biotech, pharmaceutical, and medical device companies recently announced the acquisition of OKRA.ai, a leading technology company active in the development of artificial intelligence (AI) solutions for commercialization, medical, real-world evidence and data analytics, and pricing for the life sciences and pharmaceutical industries.
JelikaLite Corp | January 07, 2022
JelikaLite Corp, a medical technology company, announced that the U.S. Food and Drug Administration has granted the Breakthrough Device Designation to its Cognilum System for the reduction of symptoms of moderate to severe autism spectrum disorder in pediatric patients who are 2 to 6 years of age.
The FDA’s Breakthrough Device Program recognizes medical devices that meet the criteria and hold the potential for more effective treatment or diagnosis of life-threatening or irre...
PharmaTimes | March 30, 2020
AstraZeneca has revealed plans to signed a multi-year non-exclusive license agreement with ImaginAb, in order to license the latter’s ImaginAb’s CD8 ImmunoPET technology. The companies say that under the terms of the agreement, the technology will be used in AstraZeneca’s clinical trials in Europe and North America to facilitate clinical development of AstraZeneca’s novel immunotherapies and to advance the clinical utility of ImaginAb’s CD8 ImmunoPET. CD8 ImmunoPET ...
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