The FDA expanded the approved indication for Genetech's Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza for patients 12 years of age and older after contact with an individual who has the flu.
Vida Diagnostics Inc has received 510(k) clearance from the FDA for enhancements to its LungPrint solution.
The AnchorFast endotracheal tube fastener features integrated tube protection for critical care teams that want an extra measure of patient protection.
The BinaxNOW COVID-19 Ag Card is the first antigen test where results can be read directly from the testing card, a similar design to some pregnancy tests.
Read More
Convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients, the FDA said.
Read More
As of Aug 13, 2020, the FDA has now authorized 213 COVID-19 tests under emergency use authorizations.EUAs, including 174 molecular tests, 37 antibody tests, and 2 antigen tests.
Read More
The FDA granted accelerated approval to Viltepso (viltolarsen) injection for the treatment of Duchenne muscular dystrophy in patients with a specific gene mutation.
Read More
The FDA has approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing technology to ID EGFR gene mutations in metastatic non-small cell lung cancer.
Read More
The FDA authorized the GO2vent with PEEP valve for use by properly trained personnel to deliver emergency, short-term, ventilator support.
Read More
Vitalograph’s next generation In2itive e-Diary combines in-clinic spirometry, home monitoring of respiratory endpoints, and eCOA data gathering functions in a robust, handheld medical device.
Read More
Breztri Aerosphere is a single-inhaler, fixed dose triple-combination of the ICS budesonide, the LAMA glycopyrrolate, and LABA formoterol fumarate.
Read More
The FDA authorized a Quest Diagnostics COVID-19 test for “pooled” samples, allowing four people to be tested with one assay.
Read More
Hillrom has launched the Hillrom Extended Care Solution, a new, connected remote vital signs monitoring device that combines the Welch Allyn Spot Vital Signs 4400 device with the Connex App and clinician review portal.
Read More
Hillrom has launched the Volara System, an oscillation and lung expansion therapy, and the Synclara Cough System, a cough assist device that uses mechanical insufflation-exsufflation.
Read More
Enzo Biochem Inc has received FDA Emergency Use Authorization (EUA) for its Ampiprobe SARS-Cov-2...
Read More