amanda.pedersen

Cook Pulls Zenith Alpha Graft Due to Blood Clot Risk

Posted by amanda.pedersen on August 18, 2017
Cook Medical Inc. recalled its Zenith Alpha Thoracic Endovascular Graft for the treatment of blunt traumatic aortic injury due to the potential for blood clots to form inside the device after it has been implanted.Staff ReportAn implantable device used to treat injuries in a patient's main blood ves... Continue

Has Mylan Paid Enough for Its EpiPen Mistakes?

Posted in by amanda.pedersen on August 17, 2017
Mylan finalized a $465 million DOJ settlement in an effort to put its EpiPen drama in the rearview mirror.Amanda PedersenMylan CEO Heather Bresch said the company's finalized settlement brings closure for Mylan and its stakeholders. The $465 million settlement agreement that Mylan reached with ... Continue

Can Olympus Curtail This Device's Bad Rap?

Posted in by amanda.pedersen on August 16, 2017
The company wants to study hysterectomy patients to show a revamped version of its power morcellator is safe and effective. But is the proposed study good enough?Amanda Pedersen  Olympus plans to study a containment device designed to prevent undetected cancer cells from spreading during g... Continue

Apollo Defends Obesity Balloon Following FDA Alert of Deaths

Posted in by amanda.pedersen on August 11, 2017
After FDA alerted physicians that several patients have died soon after having an intragastric balloon placed in their stomach for obesity treatment, Apollo Endosurgery said its Orbera actually has a "very low mortality rate" of 0.01%.Amanda PedersenApollo Endosurgery said its Orbera balloon, a... Continue

How Missile Defense Technology Is Fighting Cancer

Posted in by amanda.pedersen on August 11, 2017
A missile defense algorithm developed for President Reagan's "Star Wars" program is used in the WATS3D biopsy system for detecting pre-cancerous esophageal conditions.Nancy CrottiA study found the WATS3D (Wide Area Transepithelial Sampling with 3D Tissue Analysis) system, made by CDx Diagnostics, to... Continue

Are Weight-Loss Balloons Killing Patients?

Posted in by amanda.pedersen on August 10, 2017
FDA is keeping tabs on two liquid-filled intragastric balloon systems used to treat obesity because at least five patients have died within a month of having the insertion procedure.Amanda PedersenReShape Medical's Integrated Dual Balloon System, approved by FDA in 2015, is one of two balloon-based ... Continue

The Liquid Biopsy Surge Is Reaching Beyond Cancer

Posted in by amanda.pedersen on August 9, 2017
p.p1 {margin: 0.0px 0.0px 0.0px 0.0px; font: 11.0px Helvetica} span.s1 {font-kerning: none} span.s2 {font-kerning: none; background-color: #fefefe} Investors just poured $50 million into a blood-based test for infectious diseases, developed by Karius Inc.Amanda Pedersen Liquid biopsy has a... Continue

Medtronic Hits Illinois With Job Cuts

Posted in by amanda.pedersen on August 8, 2017
The company is closing its distribution center in Joliet, IL, which will put 185 people out of a job.Staff Report Medtronic said it will lay off 185 people as it closes a distribution center in Joliet, IL. The company plans to close the facility by December in order to leverage other U.S.-based... Continue

Can Veins-Turned-Arteries Save Blood-Starved Feet?

Posted in by amanda.pedersen on August 8, 2017
LimFlow is touting recent results from a pilot study of its system, which is designed to switch blood flow from a blocked artery in the leg to a nearby vein to restore circulation.Nancy Crotti The LimFlow procedure uses two ultrasound-guided catheters, one venous and one arterial, to create an ... Continue

How Stryker is Stepping Up Its Deformity Correction Game

Posted in by amanda.pedersen on August 7, 2017
Stryker's new Hoffmann LRF Hexapod hardware and online application uses an advanced measurement tool that could take deformity correction to the next level.Amanda PedersenStryker's foot and ankle business recently launched the Hoffmann LRF Hexapod hardware and online application, which features an a... Continue