LONDON: Polarean Imaging plc (AIM: POLX), a commercial-stage medical imaging technology leader in advanced Magnetic Resonance Imaging (“MRI”) of lung function, announces that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company’s specialised MRI Chest Coil to now include GE HealthCare 3 Tesla (3T) MRI scanners for the…
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FDA signals intent to regulate lab developed tests
DUNEDIN, NZ: Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) notes the U.S. Food and Drug Administration (FDA) has released for public comment proposed rule changes that seek to have Laboratory Developed Tests (LDTs) such as Cxbladder regulated as medical devices under the US Federal Food, Drug, and Cosmetic Act. The proposed changes, if finalized,…
Musk’s Neuralink gets FDA approval for brain implant trial
Neuralink, the neurotech startup co-founded by Elon Musk, has received approval from the Food and Drug Administration to conduct its first in-human clinical study of its brain implant device. The device, called the Link, is designed to help patients with severe paralysis control external technologies using only neural signals. This means patients with severe degenerative…
Alzheimer treatment granted fast track designation by the FDA
STOCKHOLM: BioArctic AB’s partner Eisai announced today that lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of early Alzheimer disease (AD), was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). The FDA granted Breakthrough Therapy designation for lecanemab in June of 2021. Breakthrough Therapy designation and Fast Track…
Diurnal receives agreement from US FDA
LONDON, UK: Diurnal Group plc announced the US Food and Drug Administration (FDA) has agreed a Special Protocol Assessment (SPA) for Chronocort (modified-release hydrocortisone) for the design, endpoints and statistical analysis approach of a pivotal study of Chronocort for the treatment for Congenital Adrenal Hyperplasia (CAH) in the US. The SPA provides agreement that the…
Atox Bio announces FDA acceptance of new drug application
LONDON: Arix Bioscience plc, a global venture capital company focused on investing in and building breakthrough biotech companies, notes that its portfolio company Atox Bio, announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for reltecimod. The proposed indication is for the treatment of suspected organ dysfunction or…
PRA Health Sciences appoints senior FDA official Isaac Rodriguez-Chavez
RALEIGH: PRA Health Sciences Inc. announced the appointment of Isaac Rodriguez-Chavez, PhD, MHS, MS, as Senior Vice President, Scientific and Clinical Affairs. He will lead the company’s Global Center of Excellence for Decentralized Clinical Trial (DCT) Strategy. Dr. Rodriguez-Chavez’s responsibilities will involve the continued growth and development of PRA’s industry-leading decentralized clinical trial strategy, regulatory…
IQ-AI Ltd’s LSN software receives FDA clearance
LONDON: IQ-AI Limited announced that the US Food and Drug Administration (FDA) has granted 510(k) market clearance for the Liver Surface Nodularity (LSN) software application. Earlier this year, IQ-AI’s subsidiary, Imaging Biometrics, LLC (“IB”), entered into a business agreement with the owners of LSN, AI Metrics, LLC, which granted IB global rights to manufacture, market,…
GE Healthcare’s Voluson SWIFT receives 510(k) clearance from the FDA
LONDON: Intelligent Ultrasound, the artificial intelligence (AI) based ultrasound software and simulation company, announced that GE Healthcare’s Voluson SWIFT ultrasound machine that incorporates GE Healthcare’s SonoLyst software with Intelligent Ultrasound’s ScanNav Assist AI technology, has received 510(k) clearance from the FDA for sale in the USA. SonoLyst is the world’s first fully integrated AI tool…
U.S. FDA approves Gilead’s antiviral Veklury (remdesivir) for treatment of COVID-19
FOSTER CITY: Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. As an antiviral drug, Veklury works to stop replication of SARS-CoV-2, the virus that causes COVID-19. Previously authorized by the FDA for emergency use…
FDA Approves initiation of IGC’s cannabinoid trial on Alzheimer’s patients
POTOMAC: India Globalization Capital announced that on July 30, 2020, the U.S. Food and Drug Administration (FDA) notified IGC that it has authorized the Company to initiate a Phase 1 human trial study for the Company’s investigational cannabinoid formulation for the treatment of patients suffering from mild to severe dementia due to Alzheimer’s disease. After…
Aroa Biosurgery secures FDA clearance for Symphony
PERTH: Aroa Biosurgery Limited has received clearance from the U.S. Food and Drug Administration (FDA) for new product Symphony, which is designed to reduce the time to wound closure, particularly where patients have severely impaired healing or are compromised by other diseases. Aroa Chief Executive Brian Ward said that following the FDA clearance, which was…