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Medical Devices

Class 1 Recall of Medtronic Synergy Cranial Software

FDA classifies as Class 1 a Medtronic recall of its Synergy Cranial Software and Stealth Station S7 Cranial Software due to reports of incorrect infor...

Medical Devices

Attend to Cybersecurity Guidelines: Attorney

Attorney Paulette Thomas says hospitals and other medical device vendors should pay attention to recent FDA guidelines on medical device cybersecurity...

Marketing

Medical Marketing Grows, Oversight Limited: Study

A JAMA Special Communication says spending on medical marketing increased significantly between 1997 and 2016, but oversight of such marketing has rem...

FDA General

FDA Employees Fear Shutdown Could Be Deadly

CNN reports FDA employees saying they fear the government shutdown at their agency could cost lives, and commissioner Scott Gottlieb asks the network ...

FDA General

Separate FDA Spending Bill to Get House Vote

The U.S. House of Representatives plans to vote this week to fund FDA under an Agriculture, Rural Development, Food and Drug Administration, and Relat...

Medical Devices

Questioning FDAs Old Predicate Concern

Attorney Jeffrey Shapiro questions the need for an FDA push to get 510(k) submissions to rely on newer predicates.

Human Drugs

Awak Tech Gains Breakthrough Status for Dialysis Device

FDA grants Awak Technologies a breakthrough designation for its Awak Peritoneal Dialysis device, a wearable and ultra-portable peritoneal dialysis sys...

Medical Devices

FDA Clears Empaticas Pediatric Epilepsy Smartband

FDA clears an Empatica 510(k) for its Embrace, a pediatric epilepsy smartband that detects patterns in motion and physiological signals that may be as...

FDA General

Make FDA Independent: 7 Former Commissioners

Seven former FDA commissioners call for sweeping changes to transform FDA into an independent federal agency that is not part of HHS.

FDA General

FDA Shutdown Enters 3rd Week and Challenges Mount

As FDA enters the third week of the partial government shutdown, agency employees still on the job face increasing challenges with fulfilling public h...