HomeRegulatory & Quality

Regulatory & Quality

Enter your email above to receive messages about offerings by Informa, its brands, affiliates and/or third-party partners, consistent with Informa's Privacy Statement.

Leave this field blank

SyncThink to Bring Eye-Tracking Tech to Europe

Aug 11, 2022

The company has received CE mark certification to sell its Eye-Sync technology in the European Union and United Kingdom.

Surgalign’s ‘Busy’ Week Highlighted by Plummeting Shares

Aug 10, 2022

Surgalign released its 2Q22 financial results showing decline, announced its global settlement with Resolve/RTI, and saw shares plummet 23%.

Medicare Fraud Case Evokes Theranos Déjà Vu

Aug 09, 2022

Another Silicon Valley executive is on trial for defrauding Medicare with lies about its blood test.

NeuroOne Tries Again for Long-Term sEEG Clearance

Aug 09, 2022

After FDA shot down the company's earlier bid for extended use of the device, NeuroOne has now filed a special 510(k) submission.

NICE Updates Guidance on Pre-eclampsia Testing

Aug 01, 2022

The United Kingdom's National Institute for Health and Care Excellence (NICE) now recommends one of four tests for suspected preterm pre-eclampsia.

First IVDR for Class D Medical Device

Jul 27, 2022

Roche Diagnostics manufactured the newly certified high-risk diagnostic product.

Philips Could Be Approaching a DOJ Settlement

Jul 25, 2022

Philips is in consent decree talks with the U.S. Department of Justice related to the company's ongoing recall of sleep apnea and ventilator machines.

iRhythm & Verily’s AI Watch System Wins FDA Nod

Jul 22, 2022

Now instead of the usual timepiece, iRhythm’s Zio Watch monitors atrial fibrillation, continuously and long term to aid in diagnosis.

Caption Health AI System Gets EU Nod

Jul 21, 2022

The company’s AI ultrasound technology could help lower cardiovascular disease morbidity and mortality through early detection, accessibility, and cost-effectiveness.

Europe's MDR May Be Hurting Innovation

Jul 21, 2022

Four startling conclusions from a Medtech Europe survey on how the new Medical Device Regulation (MDR) is impacting innovation in the EU.

Regulatory & Quality

Keep You Informed