Blog Tag: FDA Approval

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,

FDA Approves “First-of-its-kind” Infant Medical Device

FDA Approves “First-of-its-kind” Infant Medical Device

The U.S. Food and Drug Administration (FDA) recently authorized the use of what it described as a “first-of-its-kind” medical device to treat infants for a birth defect called esophageal atresia, in which the upper esophagus

FDA Approves Medtronic Melody TPV For Implantation in Failed Pulmonary Heart Valves

Medtronic recently announced that its Melody® Transcatheter Pulmonary Valve (TPV) is the first transcatheter pulmonary valve to receive FDA approval for implantation in patients with failed surgical bioprosthetic pulmonary

FDA Approval for Medtronic’s Reveal LINQ ICM with TruRhythm Detection

On March 13, 2017, Medtronic announced FDA 510(k) clearance for its Reveal LINQ Insertable Cardiac Monitor (ICM) with TruRhythm Detection.

Previously, Medtronic received Ministry of Health, Labor and Welfare approval for the device 

First FDA Approval of Closed-Loop Insulin Pump

First FDA Approval of Closed-Loop Insulin Pump

Medtronic’s MiniMed 670G system was recently approved by the FDA – this marks the first-ever FDA approval of a hybrid closed-loop insulin delivery system.  Medtronic explains that the system uses a computer algorithm in combination

FDA Planning Board Emphasizes Use of Data Sharing in Medical Device Monitoring

The FDA‘s planned National Evaluation System for Health Technology (NEST) will focus on new forms of clinical data, data sharing, and advanced analytics as the keys to optimizing the medical device ecosystem, says 

“World’s Smallest Pacemaker” Experiences Sizeable Success

“World’s Smallest Pacemaker” Experiences Sizeable Success

Medtronic recently announced continued success with what it describes as “the world’s smallest pacemaker.”  The Micra® Transcatheter Pacing System (TPS) is less than one-tenth of the size of traditional pacemakers (examples

FDA Issues Proposed Guidance for Changes to Medical Device Software

FDA Issues Proposed Guidance for Changes to Medical Device Software

The U.S. Food & Drug Administration (FDA) issued a proposed guidance on August 8, 2016, regarding software changes to medical devices.  The proposed guidance relates to requirements for submitting medical device software

FDA Approves Medtronic Prestige LP Cervical Disc for 2-Level Use

FDA Approves Medtronic Prestige LP Cervical Disc for 2-Level Use

The FDA recently approved the Medtronic Prestige LP Cervical System for treating degenerative disc disease at two adjacent vertebral levels (between C3 and C7). The device is said to be Medtronic’s third clinically-proven

FDA Approves AspireAssist Obesity Device

FDA Approves AspireAssist Obesity Device

On June 14, 2016, the U.S. Food and Drug Administration approved AspireAssist, an obesity treatment device that uses a surgically-placed tube to drain a portion of the stomach contents after every meal.  According to a press release

First-Ever FDA Approval of Liquid Biopsy for Detecting Lung Cancer

The New York Times reports that Roche, a Swiss biotech company, recently received the first-ever FDA approval for a “liquid biopsy” test for diagnosing non-small cell lung cancer (NSCLC).  The Times reports that while the test may not

Roche Adds FDA-Approved HIV-1 Assay To Its Cobas® 6800/8000 Systems

Roche Adds FDA-Approved HIV-1 Assay To Its Cobas® 6800/8000 Systems

Swiss biotech company Roche announced on December 21, 2015 that the FDA has approved the Cobas® 6800 and 8800 Systems from its Pleasanton, California-based Roche Molecular Diagnostics (RMD) for the Cobas® HIV-1 viral load

FDA Classifies Transvaginal Pelvic Mesh As “High Risk” Medical Device

The U.S. Food and Drug Administration issued two final orders on Monday, January 4, 2016 to strengthen the data requirements for transvaginal surgical mesh devices that repair pelvic organ prolapse (POP). First, the agency reclassified

NuVasive Receives First-Ever 510(k) Clearance for a Cervical Corpectomy Cage

NuVasive Receives First-Ever 510(k) Clearance for a Cervical Corpectomy Cage

Spinal device specialist NuVasive recently received section 501(k) FDA clearance for its X-Core Mini Cervical Expandable VBR System, a titanium vertebral-body replacement device used in the cervical spine to replace vertebral bodies

VertiFlex Announces FDA Approval of Superion Interspinous Spacer System

By: Mark Speegle

(May 26, 2015) VertiFlex, Inc., announced that it has been granted pre-market approval by the FDA for its minimally invasive treatment of lumbar spinal stenosis, the Superion Interspinous Spacer System.  This approval

FDA Issues New Rules for Testing of Reusable Medical Devices

The U.S. Food and Drug Administration (FDA) recently announced its tougher new requirements for testing reusable medical devices.  According to the FDA’s News Release, the new rules are “aimed at helping device manufacturers

First Flexible Tip Ablation Catheter To Receive FDA Approval

St. Jude Medical, Inc. recently announced that the U.S. Food and Drug Administration (FDA) has approved its FlexAbility Ablation Catheter for use by electrophysiologists to treat cardiac arrhythmia.

The new catheter provides a unique

Vascular Solutions Indicted

Vascular Solutions Indicted

The Star Tribune reports that a federal grand jury indicted Howard Root, CEO of Vascular Solutions, Inc. (VSI), on one felony count of conspiracy and eight misdemeanor charges of selling unapproved and adulterated medical devices.