Did the Alzheimer's Association have a financial conflict of interest in supporting Biogen's FDA drug application?
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.
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
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.
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.
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).
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.
Large randomized, sham-controlled trial evaluates interatrial shunting in a heart failure population currently without effective treatment
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.
Milestone Achievement Reflects First Investigational Candidate to Emerge Under Multi-Target Collaboration and Triggers $10 Million Payment to Dicerna
Provides enhancements to TSolution One® Total Knee Application currently in use in hospitals and ambulatory surgery centers in the United States
AliveCor Paving the Way For A New Generation of AI-Powered Remote Cardiology
Radiologists can now securely collaborate in realtime from anywhere
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.
Two ender diagnostics products – ender LAB and ender MASS – receive FDA notification
COVID-19 Testing Efforts Immediately Expanded with Scalable Platform
CorticoMetrics announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for THINQ™, its AI-based software for use by radiologists and neurologists providing quantitative information to augment patient assessment for a number of neurological disorders and conditions.
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, announced that the United States (U.S.) Food and Drug Administration (FDA) has deferred a decision on the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection, an investigational neuromodulator product for the treatment of moderate to severe glabellar (frown) lines.
- Company Updates on Progress of Applied DNA Clinical Laboratories CLEP-CLIA Certification -
