Thursday, February 20, 2020

Thursday, February 20, 2020

Latest News

EBR SYSTEMS, INC.: FDA Grants EBR Systems Breakthrough Device Designation Status for the WiSE Cardiac Resynchronization Therapy (CRT) System

EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the WiSE CRT System for the treatment of heart failure.

CHECKPOINT SURGICAL: Receives FDA Breakthrough Designation for Nerve Regeneration Device

Checkpoint Surgical, Inc., a leader in hand-held, intraoperative neurostimulation technology for nerve protection and repair, announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for the Checkpoint brief electrostimulation therapy (BEST) system.

UNITED THERAPEUTICS CORPORATION: Announces FDA Acceptance Of Trevyent New Drug Application For Review

United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Trevyent® (treprostinil) for the treatment of pulmonary arterial hypertension (PAH).

NETECH CORPORATION: Netech Obtains FDA 510(k) Clearance for Delta 3300 - Defibrillator/Pacemaker Analyzer

Delta 3300 Is A Compact and Light Weight Precision Instrument Ideal for Testing all Defibrillators and Pacemakers

VANTAGE SOLUTIONS: Supports FDA Pilot for Verification Router Service

Vantage Solutions, the manufacturing efficiency experts, today announced it is supporting the Food and Drug Administration (FDA) Pilot for Verification Router Service (VRS) testing sponsored by rfxcel.

WONTECH: Holmium laser 'Holinwon Prima' Received FDA approval

WONTECH, a leading Korean medical device company, announced that its Holmium laser device, Holinwon Prima, received U.S. Food and Drug Administration approval.

RIDGEBACK BIOTHERAPEUTICS LP: Announces receipt of Breakthrough Therapy designation from FDA for mAb114

Ridgeback Biotherapeutics LP, a closely held biotechnology company, today announced that the Food and Drug Administration has recently granted mAb114, an experimental treatment for Ebola, Breakthrough Therapy designation.

MEVION MEDICAL SYSTEMS: Mevion’s CBCT Imaging Solution from medPhoton Receives FDA Clearance

The cutting-edge CBCT imaging system, an integrated solution with 2D and 3D imaging, is now available to Mevion systems in the U.S.

ARTHROSURVACE: Receives FDA Clearance for BOSS™ Toe Fixation System

New joint preserving implant compatible with the Toe HemiCAP DF® and ToeMotion™ Systems

KAROLINSKA DEVELOPMENT AB: Karolinska Development's portfolio company Promimic receives FDA approval for its HAnano Surface® on a spinal implant

Karolinska Development's portfolio company Promimic today announced that the company’s first spinal device utilizing HAnano Surface to improve osseointegration has now been 510(k) approved by the FDA.

Taxpayer Protection Alliance: Get behind gene therapy revolution

For millions of people who suffer from debilitating diseases, experimental gene therapies hold much promise.

CONCEPT MEDICAL INC.: Granted 'Breakthrough Device Designation' From the FDA for Its MagicTouch AVF Sirolimus Coated Balloon

Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the U.S. Food and Drug Administration (FDA) for MagicTouch AVF, its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of stenotic lesions of Arteriovenous Fistulae or Arteriovenous graft in hemodialysis treatment of renal failure.

4WEB MEDICAL: Announces FDA 510(k) Clearance of its Cervical Stand-Alone Interbody Fusion Device

Company expands implant portfolio with the addition of the Cervical Spine Truss System - Stand-Alone

BIOBEAT: First-ever: FDA Clears Biobeat's Wearable Watch and Patch for Non-invasive Cuffless Monitoring of Blood Pressure

Biobeat, a bio-medical technology company developing advanced sensing and remote monitoring solutions for patients, announced today that the U.S. Food and Drug Administration (FDA) has granted a 510K clearance for its patch and watch for measurement of blood pressure, oxygenation and heart rate in hospitals, clinics, long-term care and at home. Biobeat's products enable cloud-based healthcare with connectivity either through a smartphone or a dedicated gateway.

FDA reviews data manipulation in AveXis' new gene therapy drug for children

One month after the approval of a new gene therapy drug for a rare disease in children, the Food and Drug Administration was informed by AveXis Inc., the product’s manufacturer, about a data manipulation issue.

FDA warning about the side effects of Miracle Mineral Solution

The Miracle Mineral Solution has been a concern of the Food and Drug Administration since 2010. Once again, the FDA is warning people not to buy these products because, once the solution is mixed, it develops into a harmful bleach, causing a variety of serious and potentially life-threatening side effects.

New cloud-based vital signs measurement system approved by FDA

The new Vital Signs Measurement System from DynoSense Corp. was approved by the Food and Drug Administration on Aug. 13.

FDA Reporter