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News about "FDA Clearance"
MiniMed Gets FDA Clearance for Smartphone-Controlled Insulin Pump Flex
MiniMed has received clearance from the US Food and Drug Administration (FDA) for its latest insulin delivery device, MiniMed Flex. The new system is a compact, smartphone-controlled insulin pump designed to make diabetes management less visible and easier to handle in everyday life.
FDA Clearance | 20/03/2026 | By Darshana | 132
LEX Diagnostics wins FDA clearance for ultra-fast PCR platform to accelerate point-of-care testing
LEX Diagnostics has secured US Food and Drug Administration 510(k) clearance and CLIA waived status for its VELO molecular diagnostics system, an ultra-rapid point-of-care platform capable of delivering highly sensitive PCR results for major respiratory pathogens directly from a swab sample in under ten minutes.
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FDA Clearance | 17/02/2026 | By Darshana | 243
Sitryx receives FDA clearance of IND application for SYX-5219 for the treatment of atopic dermatitis
Sitryx’s SYX-5219 is a first-in-class, oral, disease-modifying, anti-inflammatory therapy, targeting pyruvate kinase M2 (PKM2), a critical enzyme that regulates cell metabolism.
FDA Clearance | 04/10/2025 | By Dineshwori | 254
Antag Therapeutics Gets FDA Clearance IND Application for AT-7687
The study will also explore AT-7687 as a monotherapy and in combination with semaglutide, a GLP-1 receptor agonist, in healthy obese individuals.
FDA Clearance | 09/10/2024 | By Aishwarya | 579
CD Biopharma Receives FDA Clearance for Phase I Clinical Trial of CD-001
CD-001, the company's clinical candidate, is built on its proprietary Bispecific Fusion Protein (BsFP) platform.
FDA Clearance | 20/09/2024 | By Aishwarya | 517
PhotonPharma Receives USD 2.5 Million in Seed Funding Round
This vital funding will support the Phase I clinical trial of Innocell, an innovative therapy for the treatment of advanced ovarian cancer.
FDA Clearance | 22/08/2024 | By Aishwarya | 672
Atraverse Medical Receives FDA Clearance for HOTWIRE Radiofrequency Guidewire
This device enables zero exchange left-heart access while also serving as a rail for catheter-based therapy systems.
FDA Clearance | 16/05/2024 | By Abha | 586
Terumo BCT Receives FDA Clearance for Innovative Rika Plasma Donation System with iNomi Nomogram
This development marks a key advancement in plasma collection technology, allowing for the determination of plasma collection volume based on an individual donor's height, weight, and hematocrit level at the time of donation.
FDA Clearance | 13/05/2024 | By Abha | 2146
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