Ensemble Orthopedics Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its Ensemble CMC Implant. The Ensemble CMC was designed to treat patients with early-stage osteoarthritis of the carpometacarpal (CMC) joint using…
Designed to Help the Immune System Provide Important Protection Against Invading Pathogens
3B Medical announced receiving Emergency Use Authorization from the FDA to permit use of Lumin, a UVC system, on N95 respirators during the COVID-19 pandemic.
Guerbet (GBT), a global leader in medical imaging, announced today that it received US Food and Drug Administration approval for the commercial sale of the Optiray® Imaging Bulk Package (IBP)…
Expanded Access Program Established for Patients in the U.S. Who May Benefit from Investigational Therapy While Application is Under Review
Elecsys® Anti-SARS-CoV-2 S test specifically detects antibodies against the SARS-CoV-2 spike protein
– Company Updates on Progress of Applied DNA Clinical Laboratories CLEP-CLIA Certification –
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…
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…
COVID-19 Testing Efforts Immediately Expanded with Scalable Platform
Two ender diagnostics products – ender LAB and ender MASS – receive FDA notification
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…
Radiologists can now securely collaborate in realtime from anywhere
AliveCor Paving the Way For A New Generation of AI-Powered Remote Cardiology
Provides enhancements to TSolution One® Total Knee Application currently in use in hospitals and ambulatory surgery centers in the United States
Milestone Achievement Reflects First Investigational Candidate to Emerge Under Multi-Target Collaboration and Triggers $10 Million Payment to Dicerna
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.
Large randomized, sham-controlled trial evaluates interatrial shunting in a heart failure population currently without effective treatment
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…
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…
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, 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…
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, 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…
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