ENDER DIAGNOSTICS: Receives FDA Notification for Rapid and Reliable COVID-19 Tests
Two ender diagnostics products – ender LAB and ender MASS – receive FDA notification
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FDA Issues New Policy on Dry Heat for Reuse of Certain Respirators
The U.S. Food and Drug Administration (FDA) issued guidance on the use of dry heat to help support the single-user reuse of certain particulate filtering facepiece respirators (FFRs), such as N95 respirators, by health care personnel when there is a limited supply of respirators during the COVID-19 public health emergency.
BRAID HEALTH: Granted FDA clearance for AI-powered diagnostic collaboration platform
Radiologists can now securely collaborate in realtime from anywhere
ALIVCOR: FDA Clears First of its Kind Algorithm Suite for Personal ECG
AliveCor Paving the Way For A New Generation of AI-Powered Remote Cardiology
THINK SURGICAL®: Receives FDA Clearance of Second-Generation Active Robot
Provides enhancements to TSolution One® Total Knee Application currently in use in hospitals and ambulatory surgery centers in the United States
DICERNA: Announces FDA Acceptance of Lilly’s Investigational New Drug (IND) Application for First GalXC™ RNAi Candidate Under Companies’ Global Research Collaboration and Licensing Agreement
Milestone Achievement Reflects First Investigational Candidate to Emerge Under Multi-Target Collaboration and Triggers $10 Million Payment to Dicerna
How Maryland Smith Is Helping the FDA Think About Drug Manufacturing and Risk
Pandemic-era disruptions underscored a troubling reality in the pharmaceutical industry – an outsized reliance on foreign manufacturers for the raw ingredients for drugs sold in the United States.
CORVIA MEDICAL: Completes Randomization In REDUCE LAP-HF II Pivotal Trial And Gains FDA Authorization To Provide Continued Access For The Corvia Atrial Shunt
Large randomized, sham-controlled trial evaluates interatrial shunting in a heart failure population currently without effective treatment
LANTHEUS HOLDINGS: Announces FDA Clearance for AI-Enabled Automated Bone Scan Index (aBSI) in Prostate Cancer on GE Healthcare’s Xeleris Platform
Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc., and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the use of Lantheus’ artificial intelligence enabled automated bone scan index (aBSI) product on GE Healthcare’s Xeleris platform.
NEOIMMUNETECH: Receives U.S. FDA IND Clearance for Phase 2 Study of NT-I7 (efineptakin alfa) in combination with PD-L1 checkpoint inhibitor in First-line Non-small Cell Lung Cancer
NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for the combination of its lead drug candidate, NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), and atezolizumab (Tecentriq®) for the treatment of patients with previously untreated, PD-L1-expressing, locally advanced or metastatic non-small cell lung cancer (NSCLC).
SAFKAN HEALTH: New FDA Cleared Automated Ear Cleaning Device Brings Ear Care Into the 21st Century
OtoSet by SafKan Health is the first automated ear cleaning device for the 35 million Americans affected by impacted earwax - a leading cause of hearing loss.
HAWKEYE SYSTEMS: Announces Letter of Intent to Secure Three-Year FDA Approved Nitrile Glove Supply
Hawkeye Systems, Inc. (OTCQB: HWKE)("Company"), a technology holding company focused on pandemic management products and services, is pleased to announce today it has signed a Letter of Intent (LOI) with Whistler International Korea, a leading multinational conglomerate located in Seoul with operations in Asia, Middle East and Latin American Countries.
NANOWEAR: Receives FDA 510(k) Clearance for SimpleSENSE, a Cloth-Based Wearable Remote Diagnostic Monitoring Platform
SimpleSENSE provides a continuous, simultaneous, and synchronous assessment of the heart, lungs, and upper vascular system without the need for an in-person doctor's visit
ICOTEC AG: Receives FDA Clearance for the VADER® Pedicle - System with Bone Cement Augmentation
icotec ag, the leading medical device manufacture of Carbon/PEEK spinal implants, announces the U.S. Food and Drug Administration (FDA) 510(k) clearance to market the VADER® Pedicle - System for use with bone cement for augmentation or without.
ALZHEIMER'S GERM QUEST, INC.: Alzheimer's Association Should Reveal Financial Conflict of Interest in Urging FDA to Approve Biogen Drug, Says Dr. Leslie Norins, CEO of Alzheimer's Germ Quest
Did the Alzheimer's Association have a financial conflict of interest in supporting Biogen's FDA drug application?
ACUPATH LABORATORIES, INC.: KDx Selects Acupath as Lab for URO17™ FDA Clinical Trial
Innovative Bladder Cancer Biomarker Demonstrates Compelling Clinical Utility
SENHWA BIOSCIENCES, INC.: CARE GA Receives Study May Proceed Letter from US FDA to Initiate Phase II Clinical Trial of Senhwa's Silmitasertib in COVID-19 Patients
Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on next generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, announced its clinical partner- Center for Advanced Research and Education (CARE) in Gainesville, Georgia, has received a Study May Proceed letter from the US Food and Drug Administration (FDA) to begin a phase II investigator-initiated trial (IIT) evaluating Silmitasertib, a novel orally available casein
SAFETY FIRST HEALTHCARE: CEO Shaun G. Morgan on the Extensive Offering of FDA-Certified Medical Products
Safety First Healthcare, a Delaware registered company registered with the Securities & Exchange Commission as a US-form 10 public company with factories in Vietnam specializing in the personal protective equipment business, offers an extensive range of personal protective equipment with FDA certifications for the medical community and the general public.
QUANSYS BIOSCIENCES: Receives FDA Emergency Use Authorization for its SARS-CoV-2 IgG Antibody Test that Provides Exceptional Clinical Performance
Quansys Biosciences announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its laboratory-based IgG antibody test.