RAQA NEWS ROUND UP (OCTOBER)

26 October 2019

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CE Mark Approval for Gore CARDIOFORM ASD Septal Occluder

Gore has won European CE Mark Approval for its CARDIOFORM ASD Septal Occluder for the treatment of percutaneous, transcatheter closure of ostium secundum atrial defects (ASDs).

The device, which already gained pre-market FDA approval in June consists of two discs that come together to close atrial septum defects of 8mm to 35mm in diameter.

“Larger defects typically have a greater risk for complications, like pulmonary hypertension, right heart enlargement, or atrial fibrillation. But previously, Europe didn’t have access to the GORE CARDIOFORM ASD Occluder for this range of defects,” said Matthew Gillespie, M.D., Children’s Hospital of Philadelphia, co-principal investigator of the ASSURED Clinical Study. “CE Mark makes this soft, conformable device available for the minimally invasive treatment of a broader range of ASDs.”

 

FDA Approval for Abbotts Recharge-Free Spinal Simulator

Abbott has announced it has won FDA approval for its low dose recharge free spinal stimulator, Proclaim XR neurostimulation system. 

The device is designed to treat chronic pain in patients by using the company's BurstDR stimulation waveform technology to send low doses of mild electrical pulses in order to change the signals being sent from the spinal cord to the brain.

By using low dose, low energy technology the system is allows the battery life to last up to 10 years without recharging.

 

FDA Clearance for WONTECH Hair Loss Device 

WONTECH has gained FDA clearance for its HairBoom Air Helmet for the treatment of hair loss. 

The helmet weighs only 600 grams (1.3 lbs) and uses safe low-power laser therapy (LLLT) to activate follicle cell proliferation, increase blood flow, and supply nutrition and oxygen to the hair muscles to create healthy and strong hair. 

Seung-woo Song, Chief of U.S branch, WONTECH said, "In Korean market, WONTECH 's HairBoom Air is on unrivaled position as hair loss treatment devices, but we have prepared products that are more competitive. Also, as the overall U.S. market for hair loss treatment is huge, the FDA clearance of this new product is very meaningful in order to enter the global market.

 

Breakthrough Status Awarded to Prostate Cancer Test 

Cleveland Diagnostics has won breakthrough device designation for its IsoPSA Assay prostate cancer test.

The non-invasive diagnotics device analyses the structural changes in the prostate-specific antigen (PSA) protein instead of only measuring the psa levels, which is the current standard for detecting prostate cancer. 

“We are very grateful that FDA recognises the potential of IsoPSA, the first test in our pipeline of simple, affordable and highly accurate cancer tests that focus on cancer-relevant changes to protein biomarkers in blood." said Cleveland Diagnostics CEO Arnon Chait. 

“We look forward to working closely with FDA to expedite the appropriate approvals and get this important new test into the hands of physicians.”