Search For "fda clearance"
Revolutionizing Heart Health: Frontier X Plus Gains FDA Clearance
Updated : 1 year, 6 months ago IST
New York [US], November 13: Fourth Frontier, a medical technology company based out of New York and Bangalore, announced the 510(k) clearance of the Frontier X Plus from the U.S. FDA. The Frontier X Plus is an innovative single-lead, continuous ECG monitor that is worn around the chest and w
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Sales of Apple Watch Series 9 to be halted over a patent dispute: Report
Updated : 2 years, 5 months ago IST
According to the news report, the dispute stemmed from the blood sensor monitor on the latest flagship smart Watch. The primary dispute centres around pulse oximetry, which utilizes an optical sensor to detect blood flow. Last month Masimo received Food and Drug Administration (FDA) clearanc
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alveoair has received U.S. FDA clearance, marking a significant advancemen
Updated : 2 years, 8 months ago IST
Pune (Maharashtra) [India], September 7: alveofit® (Roundworks Technologies Private Limited) is thrilled to announce that its groundbreaking product, alveoair® spirometer, has earned U.S. FDA clearance for distribution in the United States. Specializing in digital therapeutics for
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Zumutor Biologics Inc announces FDA clearance of IND application of ZM008,
Updated : 2 years, 9 months ago IST
Boston [US]/Bangalore (Karnataka) [India], August 11: Zumutor Biologics Inc "Zumutor", a Boston based biopharmaceutical company focused on developing unique novel therapeutics in immuno-oncology (I-O) today announces that the US Food and Drug Administration (FDA) has granted the company's In
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Nesa Medtech receives US FDA clearance for technology in women’s health
Updated : 2 years, 10 months ago IST
New Delhi [India], July 26: In a major stride towards improving women's healthcare, Nesa Medtech, a prominent startup in women’s health, has announced that its groundbreaking Fibroid Mapping Reviewer Application (FMRA) has received 510(k) clearance from the U.S. Food and Drug Administration
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Nesa Medtech receives US FDA clearance for its fibroid mapping reviewer ap
Updated : 2 years, 10 months ago IST
Bengaluru (Karnataka) [India], July 24: Nesa Medtech (Nesa), a private medical device company addressing clinical unmet needs for patients with symptomatic uterine fibroids, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company's F
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Axiostat becomes first indigenous wound care product to get US FDA clearan
Updated : 8 years, 2 months ago IST
Bengaluru (Karnataka) [India], Feb 28 (Businesswire India): Giving a fillip to the Government's 'Make in India' initiative, Axiostat has become the first Indian wound care product to receive 510(K) FDA clearance in the US for its pioneering haemostatic dressing.
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Morepen Gets US FDA clearance for its Bulk Drug Montelukast Sodium
Updated : 8 years, 5 months ago IST
New Delhi [India], Dec 20 (ANI-NewsVoir): The United States Food and Drug Administration (USFDA) has cleared Montelukast Sodium, a bulk drug / API manufactured by Morepen Laboratories Ltd., for sale in the US market. This gives Morepen an entry into the Rs. 2000 crore (Approx. $ 300 million)
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