360Dx

Diagnostics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

EU Group Issues New IVD Guidelines

The new guidance concerns the technical assessment of certain devices under the IVDR, which is slated to come into force in May 2022.

PerkinElmer's Muscular Dystrophy Screening Kit Receives FDA Marketing Authorization

The company's GSP Neonatal Creatine Kinase-MM kit measures the CK-MM protein and is the first test to help in newborn screening for Duchenne Muscular Dystrophy.

Nanomix Readying Multimarker Sepsis Test for Use at Point of Care

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On the heels of receiving CE marking, the firm is engaging with global distributors and preparing a submission to the FDA for US clearance.

Seventh Sense Biosystems Gets FDA Clearance for At-Home Blood Collection Device

The firm said that after its device is placed on the upper arm, blood collection usually takes between two and three minutes following the press of a button.

Roche Blood Glucose Monitor App Receives CE Mark

The company's Accu-Check SugarView app determines blood glucose ranges without a blood glucose meter by taking photos with a smartphone camera.

Dec 06, 2019

BioMérieux, Beckman Coulter, Siemens Healthineers, Others Get 510(k) Clearances in November

Dec 05, 2019

FDA Allows Marketing of Roche MRSA Test

Dec 04, 2019

Sight Dx Receives FDA Approval for CBC Analyzer, Plans US Commercial Rollout

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Dec 04, 2019

Nanomix Receives CE Mark for POC Panel Measuring Lactate, Procalcitonin, C-Reactive Protein

Dec 03, 2019

Co-Diagnostics Joint Venture Gets Clearance in India for Five MDx Tests

Dec 02, 2019

NantHealth, Qiagen Shares Increase Sharply, Myriad Declines as 360Dx Index Rises 5 Percent in November

Dec 02, 2019

Genetron Health Gets China NMPA Approval for Clinical NGS System, Files for IPO

Nov 27, 2019

Qiagen, DiaSorin Automated TB Test Gets FDA Clearance

Nov 25, 2019

Curetis Reports 17 Percent Revenue Increase for First Nine Months of 2019

Nov 21, 2019

Genedrive Receives CE Mark for Hearing Loss Assay

Nov 21, 2019

Myriad Genetics BRACAnalysis Approved by Japanese Regulators

Nov 20, 2019

FDA Warns Carolina Liquid Chemistries About Improper Use of Reagent Kits

Nov 20, 2019

Theradiag Applies CE Mark to i-Track Analyzer

Nov 20, 2019

T2 Biosystems Gets CE Mark for Direct-From-Blood Antimicrobial Resistance Panel

Nov 19, 2019

Despite FDA Clearance for NantHealth Test, Benefits of TMB Biomarker Unclear

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Nov 19, 2019

Rheonix Submits MDx System, Triplex Sexually Transmitted Infections Test to FDA

Nov 18, 2019

Aiforia Wins $2.3M EU Grant to Develop Digital Pathology Technology for Cancer Diagnosis

Nov 12, 2019

FDA Clears NantHealth Tumor-Normal Whole-Exome Test

Nov 12, 2019

Becton Dickinson Submits HPV Assay for Expanded US Premarket Approval

Nov 08, 2019

Siemens Healthineers, Thermo Fisher Scientific, DiaSorin and Others Get 510(k) Clearances in October