Search For "us fda"
Introducing iScanPro Intraoral Scanner: Empowering Dentistry with Unparall
Updated : 2 years, 7 months ago IST
Mumbai (Maharashtra) [India], August 1: Illusion Dental Lab, renowned for its groundbreaking innovations, has added efficiency and value to the dental community for over 33 years. With a legacy of nurturing dentistry, they have played a pivotal role in transforming the field with world-class
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Nesa Medtech receives US FDA clearance for technology in women’s health
Updated : 2 years, 8 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, 8 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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US, India conduct 'Operation Broader Sword' to stop international shipment
Updated : 2 years, 8 months ago IST
Conducted in June 2023, Operation Broader Sword stopped more than 500 shipments of illicit, and potentially dangerous, unapproved prescription drugs, combination medical devices, and synthetic drug precursors from reaching American consumers, the US Embassy in India said in a press release.
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Concept Medical's fourth IDE approval for the MagicTouch Sirolimus Coated
Updated : 2 years, 10 months ago IST
Tampa (Florida) [US], May 29: The US FDA, on the 24th of May 2023, granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc's Sirolimus Coated Balloon (SCB) MagicTouch PTA for the treatment of Superficial Femoral Arteries (SFA). This marks the fourth IDE approval
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US Food and Drug Administration recalls some COVID-19 at-home tests over b
Updated : 2 years, 10 months ago IST
The US FDA stated that the decision was taken over "significant concerns" of bacterial contamination.
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Concept Medical received IDE approval to investigate safety and efficacy o
Updated : 2 years, 10 months ago IST
Tampa (Florida) [US], May 1 (ANI/PRNewswire): The US FDA has granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc's novel MagicTouch Sirolimus Coated Balloon (SCB) for the treatment of Small Vessels (SV) in coronary arteries.
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Samples of eye drops linked to blindness, deaths in US are "free of contam
Updated : 2 years, 11 months ago IST
The samples of eye-drops manufactured by India's Global Pharma Healthcare,which were linked to three deaths and blindness in some patients in US, are found to be "free of contamination", said Health Ministry sources on Tuesday.
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Anihac Pharma launches new headquarter in Estonia, Europe
Updated : 3 years ago IST
New Delhi [India], February 28 (ANI/PNN): Anihac Pharma, a reputable company that produces dietary gym supplements, is excited to reveal the inauguration of its new head office in Estonia, Europe. The business is committed to offering consumers everywhere high-quality dietary products at a f
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Concept Medical granted Investigational Device Exemption (IDE) approval fo
Updated : 3 years, 1 month ago IST
Tampa (Florida) [US], February 13 (ANI/PRNewswire): Concept Medical Inc. (CMI), on 9th February 2023, received the Investigational Device Exemption (IDE) from the US FDA, for its Magic Touch Sirolimus Coated Balloon.
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Drug Regulatory body takes samples of Eye drops from Chennai-based pharma
Updated : 3 years, 1 month ago IST
After a Chennai-based pharmaceutical company was flagged by US authorities for lethal contamination in the eye drops, members of Tamil Nadu's Drug Controller and Central Drug Control Authority conducted a late-night inspection of Global Pharma Healthcare Private Limited, sources said.
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Drug regulatory body initiates probe after US FDA flags contamination risk
Updated : 3 years, 1 month ago IST
After the US regulator Food and Drug Administration warned consumers "not to purchase or use EzriCare Artificial Tears due to potential contamination", the Central Drugs Standard Control Organization (CDSCO) under the Union Health ministry and the Tamil Nadu State Drug Controller have ini
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