Archives
Senators Try to Tackle FDA's "Unnecessary Burdens"
Two senators have proposed the FDA Device Accountability Act in an attempt to speed device time to market.
(July, 2015)
The Brave New World of Healthcare Convergence
Different technologies are being leveraged in the healthcare world creating the promise of a smart, efficient, and efficacious healthcare system. Arundhati Parmar Convergence has occurred rapidly in the tech world. Think of how you dumped your Flip handheld HD video camera in favor of the smart...
(July, 2015)
Long-Term Data Bolsters Use of Implantable Miniature Telescope
New data on the long-term safety and efficacy of VisionCare's implantable miniature telescope supports use of the FDA-approved device in younger patients with end-stage age-related macular degeneration.
(July, 2015)
Customized Knee Maker Expects to Raise At Least $135M in IPO
The maker of the only completely customized total knee implant is going public and expecting to raise at least $135 million.  
(July, 2015)
5 Obesity Startups You Should Know (ValenTx)
ValenTx The Roux-en Gastric Bypass(lef) and the ValenTx endoluminal bypass system (right)   Name: ValenTx Location: Maple Grove, MN Procedur...
(June, 2015)
FDA Classification of Health Care Gowns Clarified
Since definitions have shifted over the years, new draft guidance from CDRH spells out regulatory requirements and testing needed for different types of medical gowns.
(June, 2015)
5 Obesity Startups You Should Know (USGI Medical)
USGI Medical Name: USGI Medical Location: San Clemente, CA Procedure: USGI Medical bills itself as the incisionless surgical company.  It has developed the POSE (Primary Obesity Surgery, Endolumenal) devi...
(June, 2015)
5 Obesity Startups You Should Know (ReShape Medical)
ReShape Medical Name: ReShape Medical Location: San Clemente, CA Procedure: While EnteroMedics is adopting a surgical route to tackle weight loss, ReShape Medical has developed a nonsurgical solution.  Th...
(June, 2015)
5 Obesity Startups You Should Know
Obesity has more than doubled since 1980 worldwide, according to the World Health Organization. And while Roux-en gastric bypass has been the gold standard, novel alternative treatments are being developed.  
(June, 2015)
5 Obesity Startups You Should Know (EnteroMedics)
EnteroMedics Name: EnteroMedics Location: St. Paul, MN Procedure: EnteroMedics has developed the Maestro system that includes a pacemaker-like device that is implanted under the skin. Leads extend out from that device and trans...
(June, 2015)
Dc Motors Get Smaller But Still Pack Plenty of Power
Dc motors can deliver high precision, light weight, and high efficiency in a limited amount of space. 
(June, 2015)
Bard's Drug-Coated Angioplasty Balloon Continues to Show Efficacy
The first FDA-approved drug-coated angioplasty balloon catheter shows clinical superiority over traditional angioplasty balloons.  
(June, 2015)
FDA Wants Input on Details of UDI Direct Marking Draft Guidance
FDA's draft guidance on direct marking of medical devices asks industry to weigh in on the definition of device "reprocessing."
(June, 2015)
FDA Details Benefit-Risk Analysis in IDE Draft Guidance
The agency sets out its current thinking on factors that impact decision-making about investigational device exemption applications.
(June, 2015)
FDA Approves Medtronic’s Evolut R TAVR
Medtronic’s latest generation transcatheter aortic valve is approved within days of competitor Edwards Lifesciences’ device.
(June, 2015)
ICD Use Very Low in Elderly Patients Despite Mortality Benefit
A study published in JAMA finds that less than 10% of elderly patients who survive a heart attack receive an ICD implant, although data shows many more would benefit from the technology.
(June, 2015)
Futuristic Device Gives Blind "Sight"
FDA has approved an innovative device that helps blind people visualize and recognize objects.
(June, 2015)
Medtronic Moves to Advance Aortic Business
An investment and acquisition announced by Medtronic this week show the company is committed to keeping its aortic and peripheral vascular division growing at a fast clip. 
(June, 2015)
House Votes to Repeal Medical Device Tax
As expected, the U.S. House of Representatives has passed legislation that repeals the medical device tax; industry groups cheer the news. 
(June, 2015)
Edwards Sapien 3 TAVR Approved Earlier than Expected
Early FDA approval for the next-gen Sapien 3 transcatheter aortic valve could mean rapid market share gains and steep sales growth for Edwards Lifesciences.
(June, 2015)
Expect More Trials with mHealth Data
Medidata has done the legwork to allow companies to incorporate data from mobile health wearables into clinical trials.
(June, 2015)
The DICOM Landscape: Selecting the Right Software Development Kit
Use this evaluation process and criteria to select the appropriate software development kit for your needs.
(June, 2015)
Portable Diagnostic System Picks Up the Pace of PCR
Fluoresentric’s Xtreme Chain Reaction can provide the benefits of PCR in a fraction of the time.  
(June, 2015)
How is M&A Strategy Evolving In the Medical Device World?
 A medtech expert explains how M&A strategy of large medical device companies has evolved recently. 
(June, 2015)
Watchman Meta-Analysis Shows Positive Findings for LAAC Device
A meta-analysis of Boston Scientific’s Watchman device shows better nonprocedural bleeding, mortality, and hemorrhagic stroke results for patients who received the device compared to warfarin.
(June, 2015)