US FDA
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Concept Medical receives 4th IDE Approval from US FDA for MagicTouch Sirolimus Coated Balloon
The device is used for the treatment of Superficial Femoral Artery (SFA) Concept Medical, a globally recognised leader in innovative…
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Hyd-based Startoon Labs’ physiotherapy monitoring device bags US FDA nod
Pheezee is designed to assess musculoskeletal and neuromuscular health Startoon Labs, a Hyderabad-based ISO 13485:2016 and ISO 9001:2015 Certified medical…
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SPEVIGO bags breakthrough therapy designation in US for prevention of generalised pustular psoriasis flares
The designation follows the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), which also recently…
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DeepTek.ai’s Augmento platform bags US FDA clearance
The US FDA clearance will enable to take the our offering to the US – which is the largest global…
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Cadila Pharma’s Dholka facility passes US FDA audit
US FDA Inspector Vivin George conducted the facility’s audit from April 3 to 7 The Dholka manufacturing facility of Cadila…
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Granules Consumer Health opens US packaging facility
The facility recently received US FDA approval with zero 483 observations Granules India inaugurated and launched its packaging facility through…
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Concept Medical bags second IDE approval from US FDA
Magic Touch PTA is indicated for treating Below the Knee (BTK) atherosclerotic lesions in Peripheral Arterial Diseases (PAD) Surat-based Concept…
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Shalby Global Tech, Singapore bags regulatory approval for implants, medical devices
SGT can import the said implants and medical devices from the US and sell them in Indonesia Shalby’s step-down subsidiary…
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Lupin bags US FDA approval for DETAF tabs
The product will be manufactured at Lupin’s Nagpur facility Lupin has received tentative approval from the United States Food and…
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Mankind Pharma reduces price of heart drug NEPTAZ
NEPTAZ contains a [complex, comprised of Sacubitril and Valsartan, in a specific molar ratio Mankind Pharma’s heart failure drug, NEPTAZ,…
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