Archives
FCPA Continues to Keep a Sharp Eye on Medtech
Because of their deep pockets and extensive contact with overseas government employees, medtech companies remain vulnerable to FCPA violations.
(February, 2017)
Docs Want Convenient Educational Simulation, and It's Coming
These companies are pioneering simulation technology, offering convenient, personalized solutions that satisfy the tremendous demand among clinicians for realistic training content.
(February, 2017)
Boston Scientific Feeling Good on Lotus Edge
Boston Scientific’s management expressed optimism about timelines and forthcoming data on its next-generation Lotus Edge transcatheter aortic valve.
(February, 2017)
Standards Committee Recommends UDIs on Claims Forms
The Accredited Standards Committee X12 this week recommended that unique device identifiers be required on health insurance claims forms when high-risk medical devices are implanted or removed, but the healthcare industry is divided on the move.
(February, 2017)
CDRH’s Guidance Goals for 2017
The Center publishes its priorities for draft and final guidance subjects in the coming year.
(December, 2016)
Despite Device Industry Pushback, FDA Finalizes Emerging Signals Guidance
FDA finalizes a policy that will enable the agency to notify the public about "emerging signals" for medical devices in the postmarket setting—and the device industry won't be happy.
(December, 2016)
Edwards Unveils Structural Heart Pipeline
Edwards Lifesciences reveals its plans for its transcatheter mitral and tricuspid valve replacement and repair product pipeline.
(December, 2016)
Hearing Aid Debate Reaches Congress
Senators introduce legislation that would allow patients to buy some types of hearing aids over the counter, amplifying the debate over access and best care.
(December, 2016)
Boston Scientific Gears Up for Lotus Valve with Neovasc Deal
Boston Scientific inks an agreement to acquire Neovasc's tissue processing capabilities and facility, a move that shows its plans for the Lotus transcatheter aortic valve remain front of mind.
(December, 2016)
What Might Trump's Win Mean for Medtech?
What is in store for the Affordable Care Act, the medical device tax, FDA, and CMS under the incoming Trump administration?
(November, 2016)
Edwards' ECHO Data: The Latest in the TAVR Durability Debate
Edwards Lifesciences' latest data on transcatheter aortic valve durability is positive. Are durability concerns fading? Here's the latest on the debate. 
(November, 2016)
Deep-Tissue OCT Surgical Probe Wins 2016 Dare-to-Dream Medtech Design Challenge
Judges chose the idea of a deep tissue surgical probe with OCT variable tuning as the winner of this year’s Dare-to-Dream Medtech Design Challenge.
(November, 2016)
PFO Occlusion Device Approved in United States
FDA approves St. Jude Medical's Amplatzer PFO Occluder, making it the only device approved in the United States to close the patent foramen ovale.
(October, 2016)
What is the Impact of St. Jude's Voluntary Pause of Nanostim Implants?
Implants of St. Jude Medical's leadless pacemaker Nanostim have been halted following a few reports of lost pacing and telemetry with the device.
(October, 2016)
U.S. Patients with Large Aortic Valves Get Approved TAVR Option
A significant proportion of severe aortic stenosis patients now have an FDA-approved transcatheter aortic valve offering to fit their larger native valve size.
(October, 2016)
St. Jude Deal Is Still Happening, Abbott Reassures
Abbott's CEO publicly reiterates that the acquisition of St. Jude Medical is moving forward as planned, despite recent headlines on cybersecurity and battery depletion worries.
(October, 2016)
2016 Medtech Company of the Year Finalists: Vote
           Click through to see the 2015 Medtech Company of the Year finalists Learn how to design disruptive connected health devices at BIOMEDevice San Jose December 7 & 8, 2016. 
(October, 2016)
2016 Medtech Company of the Year Finalists: Verb Surgical
Verb SurgicalVerb Surgical plans to debut a prototype of its surgical robotic system by the end of the year.A strategic partnership between Johnson & Johnson and Google’s health sciences sister company Verily, Verb Surgical is seeking to do nothing less than democratize surgery through advance...
(October, 2016)
2016 Medtech Company of the Year Finalists: Stryker
StrykerStryker expanded its analytics platform to help customers cope with bundled payments for joint replacement procedures.Nearly every medtech company today pays lip service to the idea that providers are no longer willing to pay more for technologies that come with new bells and whistles but no ...
(October, 2016)
2016 Medtech Company of the Year Finalists: Medtronic
MedtronicMedtronic's Micra was the first transcatheter pacemaker to gain FDA approval in the United States.Medtronic scored some major wins this year when it came to FDA approvals of innovative products. That was especially true in the cardiovascular and diabetes spaces.In April, Medtronic beat St. ...
(October, 2016)
2016 Medtech Company of the Year Finalists: Mazor Robotics
Mazor RoboticsMazor Robotics will launch its Mazor X surgical robotic system in late October.Robots have been all the rage in 2016, with a number of new competitors stepping up to give market leader Intuitive Surgical a run for its money. In this increasingly crowded field, Israel-based Mazor Roboti...
(October, 2016)
2016 Medtech Company of the Year Finalists: iRhythm Technologies
iRhythm TechnologiesiRhythm's Zio XT patch provides continuous cardiac monitoring for up to 14 days.With a wearable device that works and Big Data that can make a difference, San Francisco-based iRhythm Technologies has hit on a winning combination.The company’s FDA-cleared chest-worn Zio XT patch...
(October, 2016)
2016 Medtech Company of the Year Finalists: Edwards Lifesciences
Edwards LifesciencesEdwards Lifesciences could be first to market with a TMVR system.A perennial top name in the medical device industry, Edwards Lifesciences continued its solid performance this year. The Irvine, CA-based company has racked up repeated wins in its transcatheter aortic valve (TAVR) ...
(October, 2016)
2016 Medtech Company of the Year Finalists: CVRx
CVRxCVRx's Barostim Neo treats high blood pressure and heart failure using pacemaker technology.Minneapolis-based CVRx’s technology is another great example of pacemaker technology being used in areas of the body other than the heart. It is a lucrative area of expansion in the medical device indus...
(October, 2016)
2016 Medtech Company of the Year Finalists: Carbon
CarbonCarbon's CLIP process can 3-D print objects significantly faster than traditional 3-D printers.Just picture a polymer object literally rising out of a pool of liquid media in minutes rather than the hours it would take for a traditional 3-D printer to lay down material. That’s the enticing r...
(October, 2016)