Blog Tag: FDA

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FDA Issues Draft Guidance for “Least Burdensome” Approach to Device Regulation

The FDA recently issued a draft guidance document intended to “to ensure that least burdensome principles are implemented for all device-related applications and interactions with FDA.”  The FDA provides this draft guidance following 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Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently announced that the agency plans to publish a draft guidance outlining a voluntary alternative pathway for new, moderate-risk devices for use in patient care.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

Speedboat RS2 Endoscopic Device Receives FDA Clearance

UK-based Creo Medical recently announced the clearance of its Speedboat RS2 surgical endoscopic device for minimally invasive removal of lesions in the bowel.

According to the press release, the Speedboat RS2 device and the associated

Pediatric Healthcare Innovators Compete for Funding

Pediatric Healthcare Innovators Compete for Funding

The FDA, according to its website, currently supports eight consortia that provide advice and funding to help commercialize technologies for pediatric care.  The FDA defines “pediatric” as encompassing devices used

Excelsius GPSTM: Globus Medical Receives 510(k) Clearance for Robotic Surgery Platform

Excelsius GPSTM: Globus Medical Receives 510(k) Clearance for Robotic Surgery Platform

Globus Medical announced early today that the Excelsius GPSTM surgical platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as reported by a press release dated August 17, 2017.

Globus Medical, which

House Passes Bill Relaxing Reporting Requirements

The U.S. House of Representatives recently passed the FDA Reauthorization Act of 2017.  This bill seeks to change the requirement for companies to report medical device malfunctions to the FDA.  Previously, companies had to submit a report

FDA Exempts Numerous Medical Devices from 510(k) Premarket Notification Requirements

The United States Food and Drug Administration (FDA) issued a Notice on July 11, 2017, exempting 1,003 Class II medical devices from premarket notification requirements under Section 510(k).  The Notice indicates that anyone with

Trump Administration Policy Statement Calls for FDA Premarketing Activities to be Funded Entirely by Industry Fees

The Trump White House released a Statement of Administration Policy on Wednesday in response to the House of Representatives’ passage of H.R. 2430, a bill that would reauthorize the use of four FDA user fee programs: the Prescription Drug

FDA to Create New Digital Health Unit

The FDA has announced that it will create a new unit responsible for overseeing digital health products.  According to Bakul Patel, the Associate Center Director for Digital Health at FDA, the agency is working to define “what clinical

Medtronic’s Recent Interactions with the FDA

It has been a busy couple of months between Medtronic and the Food and Drug Administration (FDA), with Medtronic experiencing both recalls and approvals from the government agency.  Below is a brief summary of some recent of Medtronic’s

FDA Approves Bayer’s myBETAapp™

On May 30, 2017, Bayer announced FDA approval of a supplemental Biologics License Application for Bayer’s myBETAapp™ and BETACONNECT Navigator™.  The myBETAapp joins the growing field of medical mobile applications,