Blog Tag: Medtronic

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 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 

Potential Repeal of Medical Device Tax

With the upcoming Republican-dominated Presidency and Congress in 2017, the Affordable Care Act, or at least parts of it, look to be on the chopping block.  One of the changes that may be forthcoming is a repeal of the 2.3% medical device

Medical Device Investor Forum – Oct. 27-28 in Irvine, CA

Medical Device Investor Forum – Oct. 27-28 in Irvine, CA

OCTANe, an Orange County-based non-profit life sciences and technology accelerator organization, has announced the agenda for its 11th Annual Medical Device & Investor Forum (MDIF), which will be held on October 27-28, 2016, in

“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 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

Medtronic Acquires HeartWare for $1.1 Billion

 

Medtronic PLC has announced it has agreed to acquire HeartWare International Inc. for $1.1 billion in cash.  According to the press release, the acquisition will expand Medtronic’s portfolio of diagnostic tools and treatments

Smith & Nephew Sells Its Gynecology Business for $350 Million

Smith & Nephew Sells Its Gynecology Business for $350 Million

Smith & Nephew recently announced that it will sell its gynecology business to Medtronic for $350 million.  As part of the sale, Medtronic will obtain Smith & Nephew’s key gynecological surgical solution, called the TRUCLEAR

Abbott to Acquire St. Jude Medical for $25 Billion

A burst of potential acquisitions and consolidations occurred on April 28th in the medical device world, the largest being Abbott Laboratories‘ deal to acquire St. Jude Medical Inc.  The deal is for $25 billion dollars and would bring

Medtronic Launches FDA-Cleared OsteoCool RF Ablation System

According to Medtronic, the OsteoCool RF Ablation System has received U.S. Food and Drug Administration (FDA) 510(k) clearance and they are launching the device in the United States.

However, this news may not be surprising to some.  

FTC Approves Tornier and Wright Medical Merger

FTC Approves Tornier and Wright Medical Merger

The U.S. Federal Trade Commission (FTC) recently issued a final order that conditionally approves the merger between Amsterdam, Netherlands-based Tornier N.V. and Memphis, Tennessee-based Wright Medical Group, Inc.  Reuters reports

FDA Approves First App-Based Pacemaker Monitor

Medtronic, a medical device manufacturer based in Dublin, Ireland, recently announced FDA approval and U.S. commercial launch of its MyCareLink Smart Monitor, the first app-based remote monitoring system for implantable pacemakers.

Medtronic to Acquire Transcatheter Mitral Valve Startup

Medtronic recently agreed to pay up to $458 million for California-based Twelve, Inc., a privately-held developer of transcatheter mitral valve replacement devices.  The terms of the deal include $408 million at closing and $50 million

Medtronic Acquires Aptus Endosystems for $110 Million

Medtronic PLC recently announced its acquisition of Aptus Endosystems, further adding to its portfolio of medical device products. The acquisition was reported to be valued at approximately $110 million.

According to its website, Aptus

Medtronic Settles Federal Lawsuit for $4.41 Million

On April 2, 2015, the United States Department of Justice announced that Medtronic, a medical device manufacturer based in Ireland, reached a settlement agreement with the United States government for $4.41 million over allegations

FDA Approves Expanded Use of Medtronic’s CoreValve System; Also Receives Regulatory Approval in Japan

This week the U.S. Food and Drug Administration announced its approval of Medtronic’s CoreValve system for “valve-in-valve” (VIV) replacement. According to the FDA press release, this represents the first transcatheter

Medtronic Continues Expansion After Covidien Acquisition

Medtronic Continues Expansion After Covidien Acquisition

Medtronic PLC recently announced its acquisition of Advanced Uro-Solutions, a Tennessee-based privately-held developer of neurostimulation products for treatment of bladder control issues.  According to the Star Tribune, the terms

Final Decision in NuVasive’s Inter Partes Review of Warsaw Orthopedic Patent

The Patent Trial and Appeals Board (the “Board”) recently issued Final Written Decisions disposing of two inter partes reviews that NuVasive filed in mid-2013 regarding U.S. patent number 8,444,696 (the ’696 Patent). The ’696

Medical Device Clinical Trial Data from Johnson & Johnson To Be Made Available

According to MedicalXpress, expansive data from a company’s medical device clinical trials will soon be made broadly available to medical device researchers for the first time.  The Yale University Open Data Access (“YODA”)