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Tag: Food and Drug Administration

BrainsWay Announces First Draft Proposal for OCD Coverage by a Regional Medicare Administrative Contractor

Palmetto GBA, Administrator of Medicare in Seven States, Publishes Draft Local Coverage Determination CRESSKILL, N.J. and JERUSALEM, Israel, June 01, 2021 (GLOBE NEWSWIRE)...

The current landscape of nucleic acid therapeutics

1.Friedmann, T. & Roblin, R. Gene therapy for human genetic disease? Science 175, 949–955 (1972).CAS  Article  Google Scholar  2.Anderson, E. J. et...

QIAGEN Launches First FDA-approved Tissue Companion Diagnostic to Identify the KRAS G12C Mutation in NSCLC Tumours and Expand Precision Medicine Options in Lung Cancer

The therascreen® KRAS RGQ PCR Kit receives U.S. regulatory approval from FDA for expanded scope to include use in guiding treatment with...

PURA With ALKM and USMJ Schedules Strategic Transition Preview For Next Week

DALLAS, TX, May 28, 2021 – McapMediaWire  – Puration, Inc. (OTC Pink: PURA) today announced that next week, on Thursday, June 3rd, 2021,...

Vaccine Monitor: Vaccination Rates Continue to Inch Upwards Across Groups, Especially Among Hispanic Adults, But Few Who Are Eager to Get a Shot Remain...

4 in 10 Parents Say Their Adolescent Children Have Already Gotten a Shot or Will Do So Right Away; One Quarter of Parents...

Lawsuit: Investors bet big on Washington firm’s potential COVID-19 treatment as CEO cashed out

Investors in a biotech startup developing a COVID-19 treatment claim the firm’s leaders cashed out as stock prices surged during a publicity blitz...

Micro Interventional Devices Receives FDA Breakthrough Device Designation for the MIA™-T Percutaneous Tricuspid Annuloplasty System

Micro Interventional Devices (MID) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its MIA™-T Percutaneous Tricuspid Annuloplasty...

Varian Receives FDA “Breakthrough Device Designation” for its Cardiac Radioablation System

Varian, a Siemens Healthineers company, announced today that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation for...

Leading Vaccine Stocks Under the Microscope (PFE, NVAX, DYAI, MRNA)

The process of lining up the next wave of vaccines – Vax 2.0 – is likely already underway behind closed doors at major...

BD Leverages Artificial Intelligence To Transform Microbiology Urine Testing

U.S. Launch of BD Kiestra™ Urine Culture Application Helps Accelerate Workflow and Drive Lab Efficiency FRANKLIN LAKES, N.J., May 26, 2021 /PRNewswire/ --...

Varian Receives FDA “Breakthrough Device Designation” for its Cardiac Radioablation (CRA) System for Treatment of Refractory Ventricular Tachycardia (VT)

  PALO ALTO, Calif., May 26, 2021 /PRNewswire/ -- Varian, a Siemens Healthineers company, announced today that the U.S. Food and Drug...

Aortix Percutaneous Mechanical Circulatory Support Device: First-in-Human Cases in Cardiorenal Syndrome Reported

Aortix percutaneous mechanical circulatory support (pMCS) device in patients with cardiorenal syndrome (CRS) have been reported.Procyrion began its pilot trial in Australia and...

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