Archives
For Roche, Drugs and Diagnostics are a Perfect Match
Roche is going after the personalized medicine market by exploiting synergies between its pharmaceutical and diagnostic divisions.  
(April, 2015)
Competitors Abound But Edwards Lifesciences Rules TAVR Market
The California heart valve company beats everyone's expectations including its own by reporting strong sales in transcatheter heart valves despite competition.  
(April, 2015)
Why Manufacturers Should Consider Nitrogen Dioxide Sterilization
Nitrogen dioxide sterilization is superior to EtO for sterilizing the external surfaces of drug and biologic combination products.
(April, 2015)
New Products Breathe Life into Abbott's Diabetes Business
Abbott's flash glucose monitoring product has been a hit in Europe, and the company is now focusing on taking the technology global.
(April, 2015)
B. Braun CFO Argues for Repeal of Medical Device Tax
During a Senate subcommittee hearing on the medical device tax, the chief financial officer of B. Braun gave testimony about the tax's negative impacts on the company and its employees.
(April, 2015)
What’s So Hard about Making Orthopedic Parts?
Meeting customer specifications and verifying features are the most challenging parts of manufacturing metal orthopedic components.
(April, 2015)
Can Da Vinci Xi Turn Around Intuitive Surgical?
More than a year after it received FDA approval, the fourth generation of the Da Vinci surgical robot is seeing strong interest from customers. Now the company just needs to improve its margin on the product.  
(April, 2015)
Stryker CEO: 5 Products That Will Make 2016 a Great Year
Here are five products that Stryker CEO Kevin Lobo mentions as areas that will really drive Stryker's growth engine.   
(April, 2015)
Analyst: Leadless Pacemaker Adoption Could Be Rapid
St. Jude Medical won CE Mark a couple of years before Medtronic with their respective leadless pacemaker systems. Physicians are intrigued as both companies pursue US regulatory approval. 
(April, 2015)
Is That OUS Data Good Enough for FDA?
FDA publishes draft guidance on what trial sponsors should consider if planning to use data from trials conducted outside the United States to support U.S. approval.
(April, 2015)
Dexcom’s Apple Watch-Integrated CGM is Convenient but Won't Change the Game for Diabetics
Dexcom’s Apple Watch–integrated continuous glucose monitoring system will allow diabetics to check glucose levels discreetly.   
(April, 2015)
FDA Pilot Program Meant to Help Users of Home-Use Devices
FDA announces a home-use device labeling pilot program intended to give patients and caregivers who use medical devices at home better access to thorough information and instructions for those devices. 
(April, 2015)
St. Jude Medical Is Acquiring Spinal Modulation for $215M
After making a $40 million investment in 2013, St. Jude Medical is paying $175 million to bring Spinal Modulation, a neurostimulation company, within its fold.  
(April, 2015)
Using Dry Lubricants to Adjust for Stacked Tolerances
By overcoming stacked tolerance issues and improving medical device quality, dry PTFE lubricants are a powerful addition to an engineer’s bag of tricks.
(April, 2015)
Virtual Approaches to Taming Diabetes Get Currency
CDC provides pending recognition status to digital health companies whose online versions of its National Diabetes Prevention Program is helping at-risk people from getting Type II diabetes.  
(April, 2015)
Thoratec Shows Real World Results with ROADMAP
Thoratec's HeartMate II left ventricular assist device shows good survival outcomes versus optimal medical management at one year.
(April, 2015)
New Imaging Test Aims to Make IVF Less of a Gamble
 A new test aims to improve the subjective visual practice of embryo selection in vitro fertilization with better imaging and data. 
(April, 2015)
HeartWare Hits Primary Endpoint in Destination Therapy Trial, but More Strokes Seen
HeartWare's HVAD left ventricular assist device for heart failure showed non-inferiority in stroke-free survival, but a significantly higher rate of strokes in the first cohort of the device's trial for a destination therapy indication.
(April, 2015)
MDMA Pushes Back on Innovation Act
The Medical Device Manufacturers Association petitions House Committee to think better of passing H.R. 9, The Innovation Act.
(April, 2015)
FTC: MelApp Can't Make Melanoma Claims
The Federal Trade Commission issues a final order barring a mobile app developer from allegedly making false claims about its ability to assess melanoma risk.
(April, 2015)
Medtech Manufacturers Rev Up ISO 13485 Certifications
With billions of dollars in contracts at stake, medical device manufacturers are pushing to conform to ISO 13485 regulatory requirements.
(April, 2015)
Medtronic's Leadless Pacer Gets CE Mark
Medtronic's Micra TPS leadless pacemaker receives CE Mark, making it the smallest approved pacemaker in the world.
(April, 2015)
IBM Teams up with Medtronic, Apple, and J&J; Formally Enters Health Market
IBM hopes to leverage its Big Data capabilities into a viable business and teams up with Medtronic, Johnson & Johnson, and Apple to transform personal healthcare.  
(April, 2015)
Medtech Startup Showdown 2015: The Winner Is...
Which company beat out all other contenders to be named champion of our Medtech Startup Showdown?
(April, 2015)
Study Says Morcellation is More Cost-Effective Despite Cancer Risk
New research finds a hysterectomy performed with morcellation, a controversial procedure linked to a higher risk of cancer, is more cost-effective than non-morcellation hysterectomy—raising the issue of medical ethics.
(April, 2015)