Archives
St. Jude Medical Settles, Closing Out Riata Suits
The company will pay less than $15 million to resolve most cases related to the Riata and Riata ST leads, which were pulled from the market in December 2010.
(February, 2015)
Analysis: Large M&A Deals Rarely Do Well In Medtech
The medtech industry is in the throes of a new wave of consolidation and megamergers, but large deals are rarely transformative finds a new report. 
(February, 2015)
Bill Seeks to Protect FDA User Fees Against Sequestration
Bipartisan FDA Safety Over Sequestration Act would exclude user fees, which are paid by industry, from potential sequestration cuts.
(February, 2015)
Dexcom Becomes Profitable for the First Time
The San Diego-based continuous glucose monitoring company becomes profitable for the first time in its history since its founding in 1999. 
(February, 2015)
Technology to Aid Embryo Selection is Now Class II
Systems that use image analysis to help clinicians decide which embryos may do best in IVF procedures are codified as Class II devices.
(February, 2015)
How Hospital Reimbursement Does and Does Not Work
A veteran sales negotiator provides a primer on how to understand hospital reimbursement procedures.
(February, 2015)
Powered Exoskeletons Deemed Class II Devices
Devices to help paraplegics walk must meet special controls to prevent risks like falls and injuries.
(February, 2015)
Drug-Coated Balloons Get Reimbursement Boost
A new transitional hospital payment from Medicare may help to boost adoption of novel drug-coated balloon catheters in hospitals to treat peripheral artery disease.  
(February, 2015)
New Device Postmarket Surveillance System Coming
A new postmarket tracking system for devices has been proposed, though implementation is years away and funding is still needed.
(February, 2015)
Solenoid Valves Evolve With Medical Devices
Although their core technology is relatively simple, solenoid valves are getting smarter and more versatile, opening up more avenues for medical device designers.
(February, 2015)
Cold or Rolled: How to Make Metal Tubing for Medical Devices
Different processes are used to fabricate metal tubing for such medical technologies as implantable devices and surgical tools.
(February, 2015)
Additional Precautions May Prevent Superbug Infections
The UCLA cases are not the first outbreak linked to hard-to-clean duodenoscopes, but stricter sterilization steps beyond FDA recommendations may help hospitals avoid more infections.
(February, 2015)
23andMe Forces FDA To Change Its Mind On Novel Genetic Testing
The consumer genetic testing company prevails in its effort to allow people access to genetic testing as FDA clears the first direct-to-consumer genetic test in the nation. 
(February, 2015)
With MRI Platform, Mass. Firm Aims To Upend Sepsis Diagnosis
A Massachusetts company aims to disrupt sepsis diagnosis by moving away from blood cultures that can take days to deliver a result.  
(February, 2015)
FDA Chief's Rumored Successor Has Ties to Device Companies
Robert Califf, a Duke University cardiologist and possible successor to exiting FDA commissioner Margaret Hamburg, has been a paid consultant to medical device and pharmaceutical companies. 
(February, 2015)
Advice for Medtech Companies: Prioritize FDA, Consumers, and Costs
Companies developing a product should communicate frequently with FDA, keep the consumer and costs in mind, and strive to accelerate the process and patient access.
(February, 2015)
Boston Scientific And J&J Feud Ends With $600M Settlement
Boston Scientific will pay $600 million to Johnson & Johnson to settle the lawsuit that the latter brought against the Massachusetts company over its purchase of Guidant in 2006.  
(February, 2015)
Medtronic Assumes Risk In Hospital Contracts For Cardiac Patients
Pushed by healthcare reform, medtech companies like Medtronic are taking the leap to sign risk-sharing agreements with hospitals to prove value of their products and services.  
(February, 2015)
Human Factors Central to Device Testing At VA in Pittsburgh
A new center at the VA in Pittsburgh Healthcare System is going to perform human factors testing on commonly-used medical devices.
(February, 2015)
Here's Proof That Home Healthcare Market Is Growing Rapidly
A new market report shows the global home healthcare market will grow to $303.6 billion by 2020. 
(February, 2015)
FDA's View on 3-D Printing Medical Devices
A CDRH representative said the agency views additive manufacturing as an enabling technology, just like CNC machining.  
(February, 2015)
Bard Hopes to Leverage Bos Sci's Heft To Sell Novel Product
C.R. Bard strikes a distribution agreement with Boston Scientific to sell its novel drug-coated balloon catheter to treat patients with peripheral artery disease.  
(February, 2015)
Here Are The Most Innovative Medtech Suppliers
UBM Canon's editorial team announces the winner of the 2015 MD&M West Supplier Innovation Challenge, which drew different submissions such as magnetic sensors, 3-D printed molds and radiopaque markers.
(February, 2015)
A Snapshot Of The Market Opportunity In India and China
A new report provides information about what the surgical market opportunity in India and China is for Western medtech companies.  
(February, 2015)
6 Emerging FDA Inspection Trends
Increased regulatory oversight has resulted in a more daunting and inconsistent inspection environment. Here are six trends you need to know to prepare for your next inspection.
(February, 2015)