Blog Tag: FDA

FDA Announces Innovation Challenge for Devices to Prevent and Treat Opioid Use Disorder

The Food and Drug Administration (FDA) has announced a medical device innovation challenge to help address opioid abuse and misuse.  With the FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder, the FDA intends

Medtronic Launches Deep Brain Stimulation Clinician Programmer for Use with Samsung Tablet

Medtronic recently announced that the U.S. Food and Drug Administration (FDA) has approved its Deep Brain Stimulation (DBS) Clinician Programmer and Activa Programming Application. Medtronic’s DBS Clinician Programmer is presently

The FDA’s Medical Device Innovation Challenge: A New Approach to Combat the Opioid Epidemic

The FDA’s Medical Device Innovation Challenge: A New Approach to Combat the Opioid Epidemic

On May 30, 2018, the U.S. Food and Drug Administration launched an innovation challenge as a way to combat the fight against opioid addiction. The challenge was issued to “spur the development of medical devices, including digital health

FDA Unveils Update to Software Precertification Program

The U.S. Food and Drug Administration (FDA) recently updated its software Precertification Program. A working program was originally rolled out in April 2018, but the program was updated in response to requested public input. The FDA

FDA grants De Novo Market Clearance of Artificial Intelligence Software

According to a U.S. Food and Drug Administration press release, Viz. AI Contact application was granted De Novo premarket review to Viz.AI’s LVO Stroke Platform. According to PR Newswire, Viz.AI’s LVO Stroke Platform 

23andMe Wins FDA Approval for Test to Detect BRCA Mutations

The U.S. Food and Drug Administration (FDA) recently authorized 23andMe to market its Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants).  According to an FDA news release, the approved test is the

FDA Approves Blood Test for Concussion

FDA Approves Blood Test for Concussion

The U.S. Food and Drug Administration has announced approval of Banyan Biomarkers, Inc.’s Banyan BTI (Brain Trauma Indicator) under the FDA’s De Novo premarket review pathway.   According to the press release, Banyan 

FDA Clears New Surgery Infection Control System

FDA Clears New Surgery Infection Control System

The FDA recently cleared Prescient Surgical’s CleanCisionTM  Wound Retraction and Protection System (CleanCisionTM), a retractable device designed to prevent surgical site infection. According to Prescient Surgical, CleanCision

Seizure-Detecting Smart Watch Given FDA Approval

The FDA has recently approved Embrace, a smart watch designed to monitor epileptic patients for seizures, according to a press release. According to the press release, the device uses machine learning to monitor patients for dangerous seizures,

MedyMatch Intracranial Hemorrhage Detection Software Receives Expedited FDA Review

MedyMatch Intracranial Hemorrhage Detection Software Receives Expedited FDA Review

Tel Aviv-based MedyMatch Technology recently announced it has received Expedited Access Pathway (EAP) designation from the FDA for its intracranial hemorrahage (ICH) detection software medical device.

According to Gene Saragnese,

FDA Issues Draft Guidance for “Least Burdensome” Approach to Device Regulation

The FDA recently issued a draft guidance document intended to “to ensure that least burdensome principles are implemented for all device-related applications and interactions with FDA.”  The FDA provides this draft guidance following 

FDA Approves Prickless Glucose Monitoring System

FDA Approves Prickless Glucose Monitoring System

The U.S. Food and Drug Administration has announced approval of Abbott’s FreeStyle Libre flash glucose monitoring system for certain diabetes patients.  The glucose monitoring tool will allow patients to monitor their glucose

FDA Pre-cert Program for Lab-Developed Tests

FDA Pre-cert Program for Lab-Developed Tests

The FDA may begin certifying the laboratories that produce lab-developed tests (“LDTs”) instead of drafting regulatory rules to cover the tests themselves.  The American Clinical Laboratory Association describes LDTs as:

[T]ests

FDA Announces Plans for Alternative Clearance Pathway

The U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently announced that the agency plans to publish a draft guidance outlining a voluntary alternative pathway for new, moderate-risk devices for use in patient care.

First-Ever De Novo Clearance by FDA’s Orthopedic Branch

According to IlluminOss Medical, Inc.’s recent press release, the company has successfully obtained the first-ever de novo clearance from the FDA’s Orthopedic Branch for its minimally invasive bone stabilizaion system

Diabetes Monitoring Technology Moving Toward Consumer Convenience

Diabetes Monitoring Technology Moving Toward Consumer Convenience

The FDA recently approved Abott’s FreeStyle Libre Flash Glucose Monitoring System.  According to Bloomberg, this device marks the first continuous glucose monitoring system that adults can use that does not use diagnosis via taking

FDA Clears First Apple Watch Medical Device Accessory

The FDA recently cleared the first medical device accessory for the Apple Watch — AliveCor’s KardiaBand.  According to AliveCor, the Kardiaband is a mobile, real-time electrocardiogram (EKG) reader that can record an EKG

FDA Provides Guidance on 3D-Printed Medical Device Products

The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices.  The guidance document, which issued on December 5, 2017, is based on the FDA’s review of more than 100 devices currently on

Netherlands Adopts US FDA-based UDI System for Medical Devices

A voluntary agreement (link in Dutch) was consummated by the Dutch Ministry of Health, industry, and hospitals. According to an Emergo blog post, under the terms of the agreement, the Netherlands will adopt the US Food and Drug Administration’s

Recall Highlights Medical Device Cybersecurity Issues

On August 29, the FDA announced a recall of 465,000 implantable pacemakers, citing concerns that hackers may be able to take control of the pacemakers’ settings. This would open patients up to danger from improper pacing or rapid depletion