Approvals

FDA Gives Nod to Cardiovascular Systems’ Replacement Saline Infusion Pump

Cardiovascular Systems received FDA marketing clearance for a redesigned saline pump used as part of the company’s Diamondback 360 orbital atherectomy systems. The 70057-03 saline infusion pump will replace the 7-10014 unit, which was recalled on April 17, 2017.

The company anticipates replacing all recalled units by no later than Aug. 31, 2017.

Crospon Receives FDA Clearance for Endoflip with Flip Topography Module

Crospon has received FDA marketing clearance for its Endoflip 2.0 imaging device, which displays esophageal patterns on a 24” touch-screen during endoscopy.

Shipments of Endoflip 2.0 systems will begin in June 2017.

Abbott Gains CE Mark for Confirm Rx Insertable Cardiac Monitor

Abbott has received a CE mark for its Confirm Rx insertable cardiac monitor (ICM), a smartphone compatible device that continuously monitors a patient’s heart rhythm and transmits information to physicians via the myMerlin mobile app.

The device is currently under review by the FDA.

FDA Clears MagVenture’s Device for the Treatment of Depression

MagVenture has won FDA marketing clearance for its MagVita TMS therapy system, which delivers transcranial magnetic stimulation for patients not responding to medication. The treatment does not require anesthesia. The device delivers magnetic pulses to the part of the brain controlling mood.

Bovie Medical Receives FDA Clearance for J-Plasma Precise Flex Handpiece

Bovie Medical has received FDA marketing clearance for its J-Plasma precise flex handpiece for use in robotic-assisted procedures including those with Intuitive Surgical’s da Vinci surgical system. The unit is controlled using a robotic grasper. The company will launch the device in the second half of 2017.

Medrobotics Wins FDA Clearance for Flex Robotic System

Massachusetts–based Medrobotics Corp. has received FDA marketing clearance for its Flex robotic system for colorectal procedures.

The minimally invasive Flex robotic system allows surgeons to navigate complex anatomy through a single, small entry point to operate in difficult-to-reach places. Medrobotics received its initial FDA clearance for the Flex robotic system in July 2015 and the CE mark in March 2014.

Abbott Gains CE Mark for Tacticath Contact Force Ablation Catheter

Abbott has received a CE mark for its sensor enabled TactiCath contact force ablation catheter, which is designed to assist in treating atrial fibrillation. The device’s magnetic sensor integrates with the Abbott EnSite Precision cardiac mapping system to collect magnetic and impedance data. The device is available in select markets in Europe, with full market release expected in the third quarter. Abbott is pursuing approval in the U.S.