Archives
ConsumerMed Connected Device Makers: Yay or Nay on FDA?
Connected consumer medical products have gone mainstream, but device makers are still taking different routes to market. Here's why some companies have sought out FDA oversight while others skip it. 
(August, 2016)
Could This Device Offer Faster Bleeding Control?
Arch Therapeutics' AC5 Topical Hemostatic Device was found to be safe and faster at controlling bleeding than standard treatment in a small trial. What makes this technology unique?
(August, 2016)
Concussion Devices First to Be Cleared in New FDA Category
FDA grants two ImPACT devices de novo clearance, making them the first devices cleared in the new Computerized Cognitive Assessment Aid for Concussion category. 
(August, 2016)
For Hospitals, Mobile Devices Are a Blessing and a Curse
Mobile communications platforms can help hospitals improve workflow, but they also pose risks for patient data, technology infrastructure, and medical devices. 
(August, 2016)
What an Intermediate-Risk Label Means for Sapien 3
FDA has just granted an expanded indication to intermediate-risk patients for Edwards Lifesciences' Sapien 3 transcatheter aortic valve. Here's what that might mean for the field of TAVR therapy.
(August, 2016)
Here's When You Need to Tell FDA About a Modification
FDA sets out to clarify when it needs to be informed of modifications and software changes made to medical devices.
(August, 2016)
New Technology Helps Metal Stampers Keep Pace
Using computers and sensors, metal stampers can produce micro-sized parts with tighter tolerances. 
(August, 2016)
Boston Sci Wins FDA Approval for MRI-Safe S-ICD
How does the MR-conditional version of Boston Scientific's Emblem S-ICD fit into the company's plans for its cardiac rhythm management product portfolio?
(August, 2016)
Share Trial Data? JNJ Says Yes, Others Hesitate
Some in the device industry and academia have already begun making clinical trial data available to other researchers, sensing the potential for collaboration and faster medical advancements. But there is debate about potential risks and the best way to share.
(August, 2016)
Endologix: Nellix May Need FDA Advisory Panel Meeting
Endologix's much-anticipated Nellix EndoVascular Aneurysm Sealing system may potentially be reviewed by an FDA advisory committee. How could that possibility impact the timeline and adoption of the next-generation technology?   
(August, 2016)
Exclusive: ReliantHeart's aVAD Gets CE Mark
ReliantHeart’s next-generation aVAD left ventricular assist device has just earned CE Mark approval and implants are set to begin in September.
(August, 2016)
Will Mega Medtech M&A Continue?
A deals expert dissects the factors that may change the size and volume of mergers and acquisitions in the medtech industry.
(July, 2016)
Transcatheter Mitral Valve Replacement Set for CE Mark Trial
Edwards Lifesciences is ready to study its transcatheter mitral valve replacement technology in a CE Mark trial.
(July, 2016)
Zimmer Biomet's Answer to Value-Based Care
The orthopedic giant is packaging services and technologies into an offering aimed at helping hospitals and providers adjust to and thrive under the value-based reimbursement model. 
(July, 2016)
Your Smartphone Knows If You're Sick
A new smartphone app that can passively determine whether a person is feeling sick or unwell is being used to study how diabetes affects the people who have it.
(July, 2016)
4 Products Coming Down the Pike at St. Jude Medical
Here's a look at the new technologies St. Jude Medical expects to gain approval in the U.S. by the end of the year. 
(July, 2016)
Dexcom's Bid for Non-Adjunctive Label Blessed by Panel
An FDA advisory committee voted in support of a non-adjunctive indication for Dexcom's G5 Mobile Continuous Glucose Monitoring system.
(July, 2016)
Wearables Will Help Researchers Improve Therapy for Multiple Myeloma Patients
Mobile health data collected through a fitness tracker will be used to learn more about how multiple myeloma patients feel as they undergo induction chemotherapy. 
(July, 2016)
How Intuitive Surgical Is Preparing for the Battle of the Bots
Competition among surgical robotics companies may be heating up, but the current leader in the space counts a $4.2 billion war chest among its advantages. 
(July, 2016)
Effort to Add UDI to Device Claims Data Gaining Momentum
The ongoing efforts to add unique device identifier data to insurance claims forms got a boost last week as CMS publicly backed the idea.
(July, 2016)
Zimmer Biomet Joins Surgical Robotics Race
The ortho giant’s purchase of French surgical robotics firm Medtech could give competitor Mazor Robotics a run for its money, according to one analyst. 
(July, 2016)
Survey: Device Tax Suspension Lifting Hiring, R&D
A small survey finds that the medtech industry is already benefiting from the suspension of the medical device tax. Learn how executives say they're investing the savings.
(July, 2016)
Designing Joint Implants That Enhance Patient Satisfaction
Here's how custom 3-D printing, porous metals, and innovative biomaterials are transforming knee and hip joint replacements. 
(July, 2016)
Details on ReliantHeart's Impressive LVAD Technology Cache
Yes, that fully-implantable wireless LVAD really is in the works. While Thoratec and HeartWare are being absorbed into large medtech companies, ReliantHeart's CEO says his standalone LVAD company is debuting the most exciting features in the field.
(July, 2016)
Will Medtronic-Backed Mazor Robot Be a Boon to Spine Surgeons?
Mazor Robotics reveals the many new capabilities of its forthcoming Mazor X robotic system, which is being copromoted by Medtronic.
(July, 2016)