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ABIOMED: FDA Approves Data Streaming from the Impella Console, Setting the Stage for Artificial Intelligence Algorithms to Further Improve Patient Outcomes

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.

HD MEDICAL: Awarded FDA Clearance For HD Steth

Intelligent Stethoscope with Integrated ECG delivers Instant Cardiac Insights

SOLITON: Receives FDA Acceptance for 510(k) Application

Rapid Acoustic Pulse ("RAP") device 510(k) Application Accepted for cellulite reduction

AMNEAL: Launches Generic Fluphenazine Following ANDA Approval by FDA

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for a generic version of Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg.

COCHLEAR LIMITED: Cochlear obtains FDA approval of Kanso 2 Sound Processor, first off-the-ear cochlear implant sound processor with direct smartphone connectivity

Approval also includes extending the Nucleus 7 Sound Processor to the first U.S. cochlear implant recipients, Custom Sound Pro fitting software to enhance support for hearing professionals

ABBOTT: Receives FDA Approval for New Heart Rhythm Devices Featuring Bluetooth Connectivity and Continuous Remote Monitoring

Next-generation Gallant™ implantable cardioverter defibrillator family of devices offers Bluetooth® capability for a more meaningful connection between patients and their doctors

IVWATCH: SmartTouch™ Sensor Receives FDA Clearance for Continuous IV Site Monitoring

FDA clearance expands product portfolio with the introduction of a miniaturized and disposable IV infiltration and extravasation detection sensor

SOTERIX MEDICAL INC.: FDA Grants Soterix Medical IDE Approval for Home-based tDCS-LTE Trial for Depression

Soterix Medical Inc. announces it has received FDA Investigational Device Exception (IDE) to launch a trial of transcranial Direct Current Stimulation-Limited Total Energy (tDCS-LTE) neuromodulation at-home for patients with Major Depressive Disorder (MDD).

VIIV HEALTHCARE: Announces US FDA Approval for Rukobia (fostemsavir), a First-in-Class Treatment for HIV in Adults With Few Treatment Options Available

In a phase III study, a majority (60%) of heavily treatment-experienced adults randomized to receive Rukobia with an optimized background therapy achieved and maintained viral suppression through 96 weeks, addressing a critical unmet need

LIVSMED: Receives FDA 510(k) Clearance for ArtiSential™ Articulating Energy Laparoscopic Instruments

LivsMed Inc. receives 510(k) clearance from the FDA for its ArtiSential™ articulating bipolar energy instruments for electrosurgical cutting and coagulation. ArtiSential™ devices feature the patented, double-jointed end effector, which allows surgeons to overcome the challenges presented by difficult angles of approach, especially in complex procedures.

BIOVENTUS: Receives FDA Clearance of Strip Format of its SIGNAFUSE® Bioactive Bone Graft

Bioventus, a global leader in orthobiologic solutions, is launching its SIGNAFUSE Bioactive Bone Graft in a new strip format.

NAVISWISS: Receives FDA Clearance for its miniature Hip Navigation, expanding across markets in the U.S.

Naviswiss AG, a medical technology company based in Denver, Colorado, with headquarters in Brugg, Switzerland, receives FDA Clearance on June 10, 2020, for their new navigation technology for hip replacement surgery.

ENEXOR HEALTH SYSTEMS: Enexor Ventilators Granted FDA Emergency Use Authorization

The durable, reliable, and low-cost ventilator is ideal for COVID-19 use in hospitals throughout the world.

FDA: Approves New Therapy for Rare Disease Affecting Optic Nerve, Spinal Cord

Second FDA Approved Therapy for Neuromyelitis Optica Spectrum Disorder Offers Patients Additional Treatment Option

FDA Reporter