US FDA
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Concept Medical receives 5th US FDA IDE approval for Sirolimus drug-coated balloon
For the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the Haemodialysis management of Chronic Renal Failure Concept Medical…
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Aparna Group forays into pharma business vertical
Receives US FDA clearance for Aparna Pharmaceuticals manufacturing unit Aparna Pharmaceuticals, a leader in manufacturing Active Pharmaceutical Ingredients (APIs) and…
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Lupin launches ophthalmic solution in US
The solution is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone…
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Lupin launches Rocuronium Bromide injection in US
The injection is indicated for inpatients and outpatients as an adjunct to general anaesthesia to facilitate both rapid sequence and…
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SigTuple’s AI100 with Shonit receives US FDA 510(k) clearance
SigTuple’s AI100 with Shonit is the premier solution for AI-assisted digital pathology SigTuple, a medtech company that develops Artificial Intelligence…
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alveoair bags US FDA clearance for lung health solution
alveoair has been adopted by over 400 healthcare facilities across India alveofit (Roundworks Technologies Private Limited) announced that its groundbreaking…
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Pharmaceutical industry headwinds in remission: ICRA
US FDA inspections have gained momentum in the recent past and regulatory risks remain a key monitorable ICRA expects the…
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Granules India completes two US FDA audits for its API facilities in Vizag, Jeedimetla
The facilities received zero observations Granules India has completed the US Food and Drug Administration’s (US FDA) Pre-Approval Inspection (PAI)…
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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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