FDA Clearance for Capsule Monitor with Masimo Capnography
Capsule Technologies has received FDA 510(k) clearance for its Vitals Plus monitoring solution with the Masimo NomoLine ISA CO2 module.
Category: Business News
Business News
Latest
Business News
Latest
FDA Authorizes First COVID-19 Test Where Results Can Be Read Directly From Testing Card
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.
Business News
Popular
IB Launches Neo-Restraint System for Neonatal Transport
International Biomedical has released the Neo-Restraint, a fully adjustable close proximity support system for neonates. The Neo-Restraint is reusable and can be retrofitted to any Airborne transport incubator, according to the company.
Novel Cystic Fibrosis Drug KB407 Granted Orphan Drug Designation
Krystal Biotech Inc’s KB407 is an inhaled, repeat-dose gene therapy for cystic fibrosis currently in the preclinical phase.
Read More
Philips Releases OmniWire for Coronary Artery Procedures
Royal Philips has introduced the world’s first solid core pressure wire for coronary artery interventional procedures, the Philips OmniWire.
Read More
Tradipitant May Accelerate Clinical Improvement in Patients with COVID-19 Pneumonia
According to interim analysis reported by Vanda Pharmaceuticals Inc, tradipitant — a neurokinin-1 receptor (NK-1R) antagonist — may accelerate clinical improvement in SARS-CoV-2 (COVID-19) pneumonia.
Read More
Philips Launches Rapid Equipment Deployment Kit to COVID-19 Response
Philips introduced its Rapid Equipment Deployment Kit for ICU ramp-ups, allowing healthcare workers to quickly support critical care patient monitoring capabilities during the COVID-19 pandemic.
Read More
VivaLink Launches Monitoring Solution for Infectious Respiratory Diseases
VivaLink has launched its new multi-vital ambulatory monitoring solution for infectious respiratory diseases in the US and other regions.
Read More
3B Medical On List of 5000 Fastest-growing Companies for Second Year
Inc magazine released its annual Inc 5000 list of the country’s fastest growing companies and 3B Medical checked in at number 1,685.
Read More
FDA Authorized Six Additional COVID-19 Tests This Week
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
FDA Approves Viltepso for Rare Duchenne Muscular Dystrophy Mutation
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
FDA Approves First Liquid Biopsy + NGS Diagnostic Test for NSCLC
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
Olympus Launches New EBUS-TBNA Needle for Lung Cancer Staging and Diagnosis
Olympus has launched the ViziShot 2 25 G, an endobronchial ultrasound transbronchial aspiration (EBUS-TBNA) needle portfolio for lung cancer diagnosis and staging.
Read More
FDA Grants EUA for Vortran’s Emergency Ventilator
The FDA authorized the GO2vent with PEEP valve for use by properly trained personnel to deliver emergency, short-term, ventilator support.
Read More
FDA Approves Vitalograph’s In2itive e-Diary Spirometer
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