GI SUPPLY: Gets FDA Clearance of First Submucosal Lifting Agent in a Pre-filled 5mL Syringe
New EverLift™ device designed to reduce costs and enhance complete polyp resections
New EverLift™ device designed to reduce costs and enhance complete polyp resections
Recommendation based on review of DREAMM clinical trial programme, including the pivotal DREAMM-2 study
Rapid Acoustic Pulse ("RAP") device 510(k) Application Accepted for cellulite reduction
Intelligent Stethoscope with Integrated ECG delivers Instant Cardiac Insights
Vitls Platform Combines All the Vital Signs Required to Assess Patients Into One Wearable Device
The United States Food and Drug Administration (FDA) has approved one-way digital data streaming during patient support from Abiomed's (NASDAQ: ABMD) Automated Impella Controller (AIC), the external console used with Impella heart pumps.
Clinical Computer Systems, Inc. (CCSI), a leading provider of perinatal software, is looking forward to a successful launch of the new OBIX BeCA fetal monitor which recently obtained FDA 510(k) clearance.
First FDA authorization of laboratory technique for use in COVID-19 diagnostic testing
xMAP SARS-CoV-2 Multi-Antigen IgG Assay is enabled by xMAP Technology, the gold standard for multiplexing serologic testing
Orphazyme expects to submit MAA for arimoclomol for NPC to European Medicines Agency in the second half of 2020
Access Genetics, LLC dba OralDNA® Labs announces that FDA has issued an Emergency Use Authorization for its OraRisk® COVID-19 RT-PCR test.
IND transfer clears path for Phase 2b trials of potential Peripheral Artery Disease (PAD) treatment and opens the door to explore other vascular applications
New stroke risk reduction technology designed to advance procedural performance and safety, treat wider range of patients with non-valvular atrial fibrillation
The U.S. Food and Drug Administration published the proposed rule, Annual Summary Reporting Requirements Under the Right to Try Act, that when finalized, will implement a statutory requirement for sponsors and manufacturers to provide an annual summary to the FDA for any eligible investigational drug they provide to eligible patients under the Right to Try Act.
Goal is to Help Reduce Opioid Overdoses and Deaths
Changes would provide greater flexibility to respond to surge demands and ensure that needed medications are readily available for patient care.
Beckman Coulter today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its PK7400 Automated Microplate System and the system's reagents have completed FDA approval.
Agency Urges Consumers, Health Care Professionals Not to Use Certain Products, Citing Serious Adverse Events and Death
Plans to Initiate Phase 1 Clinical Trial This Year
Stratus™ Medical, a company focused on advancing radiofrequency (RF) ablation treatment for chronic pain, announced today FDA clearance for the Vesta RF Cannula for use in radiofrequency (RF) heat lesion procedures for the relief of pain and first Vesta patient treatments in the United States.