Submissions and Approvals

CHF Solutions Grabs 510(k) Clearance for Hypervolemia Device

February 27, 2020

The console can be used for extended periods for patients who haven’t responded to medical management. Read More

FDA Announces Pilot for PDF-Based 510(k) Template

February 27, 2020

The agency will select up to nine participants for the program. Read More

EmCyte Nabs 510(k) Clearance for Platelet Rich Plasma Concentration Device

February 26, 2020

PurePRP’s cell composition is “friendly to the local tissue environment making it an effective and well tolerated treatment application for patients,” the company said. Read More

Fujifilm Grabs CE Mark for AI-Based Colonic Polyps Detection Tech

February 26, 2020

The AI technology was trained with clinical images using Fujifilm endoscopy systems to spot colonic polyps. Read More

FDA Clears LivaNova’s Modification to Heater-Cooler Device

February 26, 2020

The heating and cooling device is designed to meet the temperature needs of patients undergoing cardiac surgery. Read More

Zynex Earns FDA Clearance for Blood Volume Monitor

February 25, 2020

The device measures six independent parameters. Read More

Kurin’s Push-Button Needle Tech Cleared by FDA

February 25, 2020

“Kurin’s patented automatic blood discard product is the only FDA 510(k) cleared blood culture product in its class,” the company said. Read More

Co-Diagnostics’ Coronavirus Test Earns CE Mark

February 25, 2020

“We believe Co-Diagnostics is the first U.S. company to receive a CE-marking for a coronavirus IVD,” the company’s CEO said. Read More

Fist Assist Devices Earns CE Mark for Vein Compression Device

February 24, 2020

The device is used in AV fistula placement and phlebotomy procedures and has not yet received FDA clearance. Read More

First Genetic Test for Fragile X Syndrome Cleared

February 24, 2020

The syndrome can cause learning disabilities, delays in development, intellectual disabilities, autism and social/behavioral issues. Read More

FDA Hands Breakthrough Device Status to Cardiovalve’s Valve Replacement System

February 21, 2020

The device can be used by 90 percent of the patient population, the company said. Read More

Biotronik Earns CE Mark for Drug-Eluting Stent

February 21, 2020

The stent system improves coronary luminal diameter in patients with symptomatic ischemic heart disease. Read More

Submissions and Approvals
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CHF Solutions Grabs 510(k) Clearance for Hypervolemia Device

FDA Announces Pilot for PDF-Based 510(k) Template

EmCyte Nabs 510(k) Clearance for Platelet Rich Plasma Concentration Device

Fujifilm Grabs CE Mark for AI-Based Colonic Polyps Detection Tech

FDA Clears LivaNova’s Modification to Heater-Cooler Device

Zynex Earns FDA Clearance for Blood Volume Monitor

Kurin’s Push-Button Needle Tech Cleared by FDA

Co-Diagnostics’ Coronavirus Test Earns CE Mark

Fist Assist Devices Earns CE Mark for Vein Compression Device

First Genetic Test for Fragile X Syndrome Cleared

FDA Hands Breakthrough Device Status to Cardiovalve’s Valve Replacement System

Biotronik Earns CE Mark for Drug-Eluting Stent

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The Revised ICH E8: A Guide to New Clinical Trial Requirements

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