FDA authorized Vela Diagnostics’ Sentosa SQ HIV Genotyping Assay
The Food and Drug Administration has given the go-ahead to what it calls the first next-generation sequencing test for detecting mutations that enable the most common strain of HIV to become immune to drugs. The FDA said that it had authorized
Impulse Dynamics secures US FDA approval for Optimizer Smart System
US-based medical device company Impulse Dynamics has secured the US FDA Supplemental-PMA approval for its next-generation, two-lead Optimizer Smart System intended for the treatment of heart failure. Impulse Dynamics has designed the Optimizer Smart System as an implantable device to deliver
Danish Smallpox Vaccine Gets FDA Approval to Fight Bioterrorism
A vaccine developed by the Danish company Bavarian Nordic has received FDA approval to prevent infections by monkeypox, as well as protect against the threat of a smallpox bioterror attack. This approval makes Bavarian Nordic’s vaccine the only approved vaccine in
FDA clears GE’s AI-powered x-ray algorithms for triaging collapsed lungs
GE Healthcare has received 510(k) clearance for AI algorithms designed to detect a type of collapsed lung on x-ray images. The FDA clearance covers a set of algorithms that GE has embedded in its Optima XR240amx mobile x-ray device, thereby
SoniVie Receives FDA Breakthrough Device Designation For The TIVUS System In The Treatment Of Pulmonary Arterial Hypertension (PAH)
SoniVie, an Israeli company developing a novel system for the treatment of PAH, today announced that it has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the Therapeutic Intra-Vascular Ultrasound (TIVUS) System in patients
Checkpoint Surgical Receives FDA Breakthrough Designation for Nerve Regeneration Device
Checkpoint Surgical, a leader in hand-held, intraoperative neurostimulation technology for nerve protection and repair, announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for the Checkpoint brief electrostimulation therapy (BEST) system. The Checkpoint BEST™
Prescient gets FDA breakthrough status for colorectal cancer test
Prescient Metabiomics has received FDA breakthrough status for its non-invasive colorectal cancer test. The test, called LifeKit Prevent, identifies microbial DNA and RNA biomarkers associated with the new, abnormal growth of tissue in the gastrointestinal tract. By detecting these changes
binx health Receives FDA 510(k) Clearance For Rapid Point Of Care Platform For Women’s Health
Binx Health, the pioneer in anywhere, anytime testing for women's health, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its first-of-kind, highly sensitive and specific, molecular point-of-care (POC) diagnostic testing