MAGVENTURE: Receives FDA clearance for OCD
FDA has cleared MagVenture TMS Therapy® for adjunct treatment of Obsessive-Compulsive Disorder (OCD).
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HELIX: Receives FDA Emergency Use Authorization for the HelixⓇ COVID-19 NGS Test, One of the First Sequencing-Based COVID-19 Tests
The high throughput test will be available in the Fall with next-day turnaround time and will enable Helix to scale its capacity to 100,000 tests per day
FDA: Approves Targeted Treatment for Rare Duchenne Muscular Dystrophy Mutation
The U.S. Food and Drug Administration granted accelerated approval to Viltepso (viltolarsen) injection for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.
FDA: Finalizes Rule Related to Gluten-Free Labeling for Foods Containing Fermented, Hydrolyzed Ingredients
The U.S. Food and Drug Administration issued a final rule to establish compliance requirements for fermented and hydroly
SWORD HEALTH: Becomes The Only Digital Musculoskeletal Care Provider With HITRUST®, SOC 2 And FDA Certifications
With HITRUST CSF Certification, SOC 2 compliance and an FDA-listed medical device, SWORD Health demonstrates its commitment to clinical-grade standards of patient security, safety, and privacy.
NOVARTIS: Announces FDA filing acceptance of Xolair® (omalizumab) prefilled syringe for self-administration across all indications
If approved, Xolair self-administration would offer a more flexible option to help select patients manage their treatment needs
UNITED IMAGING: Debuting at AHRA as a Gold Sponsor, Announces FDA Clearance of Its Latest Deep Learning Reconstruction Technology, uAI HYPER DLR
As part of the company's Software Upgrades for Life program, the upgrade will be deployed to all installed U.S. molecular imaging systems at no additional cost to customers.
MALLINCKRODT: Announces U.S. FDA Filing Acceptance of Biologics License Application for StrataGraft® Regenerative Skin Tissue for Treatment of Adults with Deep Partial-thickness Thermal Burns
StrataGraft® Skin Tissue, If Approved, Could Reduce or Eliminate the Need for Autografting of Healthy Skin to Treat Burn Wounds
KAZIA THERAPEUTICS LTD: US FDA Grants Rare Pediatric Disease Designation (RPDD) to Paxalisib for DIPG
Kazia Therapeutics Limited (ASX: KZA;NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is pleased to announce that the United States Food and Drug Administration (FDA) has awarded Rare Pediatric Disease Designation (RPDD) to Kazia's paxalisib (formerly GDC-0084) for the treatment of Diffuse Intrinsic Pontine Glioma (DIPG), a rare and highly-aggressive childhood brain cancer.
FDA: Approves New Opioid for Intravenous Use in Hospitals, Other Controlled Clinical Settings
The U.S. Food and Drug Administration approved Olinvyk (oliceridine), an opioid agonist for the management of moderate to severe acute pain in adults, where the pain is severe enough to require an intravenous opioid and for whom alternative treatments are inadequate.
FDA: Approves First Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test
The U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology to identify patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in a deadly form of metastatic non-small cell lung cancer (NSCLC).
EYENUK: Announces FDA Clearance for EyeArt Autonomous AI System for Diabetic Retinopathy Screening
EyeArt is the First FDA Cleared AI Technology for Autonomous Detection of Both More than mild and Vision-Threatening Diabetic Retinopathy
SIGHT DIAGNOSTICS: Raises $71M To Accelerate Global Expansion of its FDA 510(k) Cleared, CE Marked Finger-prick Blood Analyzer
The investment from Koch Disruptive Technologies, Longliv Ventures, a member of the CK Hutchison Holdings and OurCrowd will fuel Sight’s R&D into the automated identification and detection of diseases
PHARMACYTE BIOTECH, INC.: FDA Formally Accepts PharmaCyte Biotech’s Drug Master File for Company’s Pancreatic Cancer Therapy
PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that the Drug Master File (DMF) that its partner, Austrianova, filed with the U.S. Food and Drug Administration (FDA) has been accepted without any questions or suggested changes.
SIEMENS HEALTHINEERS AG: FDA Clears SOMATOM On.site from Siemens Healthineers For CT Head Exams at Patient’s Bedside
Mobile CT scanner reimagines head imaging of critically ill patients by enabling patients and staff to remain in ICU
LIFE SPINE: Announces FDA 510(k) Clearance for the PLATEAU®-A Ti Anterior Lumbar Spacer System
Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the PLATEAU-A Ti Anterior Lumbar Spacer System.
SURMODICS: Receives FDA 510(k) Clearance for Sublime™ Radial Access 0.014 RX PTA Dilatation Catheter
Device designed to treat below-the-knee vessels from the radial arteries with industry’s longest (250 cm) working length
ABIOMED: FDA Issues Emergency Use Authorization for Impella Heart Pumps to Provide Unloading Therapy to COVID-19 Patients
The United States Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for left-sided Impella heart pumps to provide left ventricular unloading and support to COVID-19 patients who are undergoing ECMO treatment and develop pulmonary edema or myocarditis.
FDA: Announces Voluntary Agreement with Manufacturers to Phase Out Certain Short-Chain PFAS Used in Food Packaging
The U.S. Food and Drug Administration is announcing that the manufacturers of certain per- and polyfluoroalkyl substances (PFAS) used for grease-proofing in paper and paperboard for food packaging (for example, as coatings on some fast-food wrappers, to-go boxes, and pizza boxes) have voluntarily agreed to phase-out their sales of these substances for use as food contact substances in the United States.
CAN-FITE: Submits Investigational New Drug Application to U.S. FDA for COVID-19 Phase II Study
28-day study in hospitalized patients with moderate COVID-19 symptoms