Latest News from FDA Reporter

By Press release submission | Aug 8, 2020

Device designed to treat below-the-knee vessels from the radial arteries with industry’s longest (250 cm) working length

LIFE SPINE: Announces FDA 510(k) Clearance for the PLATEAU®-A Ti Anterior Lumbar Spacer System

By Press release submission | Aug 8, 2020

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.

SIEMENS HEALTHINEERS AG: FDA Clears SOMATOM On.site from Siemens Healthineers For CT Head Exams at Patient’s Bedside

Patients

Mobile CT scanner reimagines head imaging of critically ill patients by enabling patients and staff to remain in ICU

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.

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

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

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).

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.

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.

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

Patients

By Press release submission | Aug 13, 2020

StrataGraft® Skin Tissue, If Approved, Could Reduce or Eliminate the Need for Autografting of Healthy Skin to Treat Burn Wounds

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.

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

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.

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

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.

HELIX: Receives FDA Emergency Use Authorization for the HelixⓇ COVID-19 NGS Test, One of the First Sequencing-Based COVID-19 Tests