Koning Breast CT 1000

The Koning Breast CT 1000 from Koning Corporation is a system that uses computed tomography (CT) imaging to help diagnose breast cancer. The system, which received FDA approval in January 2015, does not compress the breast, but instead enables 3D imaging of the hanging breast while the patient lies face down. The technology isn’t used in screening, but is indicated for use with patients who have signs, symptoms, or screening results that warrant...

August 4th, 2017

Omnigraft™ Dermal Regeneration Matrix

The Omnigraft™ Dermal Regeneration Matrix from Integra LifeSciences is used to encourage the growth of skin tissue. According to the company, the product consists of a silicone layer used to shield the wound, and a bioengineered scaffold used to encourage formation of new dermal tissue. Approved by FDA in May 2016, the matrix is indicated to treat certain neuropathic diabetic foot ulcers that have existed for more than six weeks.

August 4th, 2017

SpyGlass DS™ Direct Visualization System

The SpyGlass DS™ Direct Visualization System from Boston Scientific is used to endoscopically visualize the biliary and pancreatic ducts during diagnosis and treatment. FDA-cleared in February 2015, the system is designed to make visualization...

August 4th, 2017


The THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® Surround Flow Catheters, and the CARTO SMARTTOUCH™ Software Module from Biosense Webster, part of the Johnson & Johnson family of companies, is used for ablation treatment in patients with drug-resistant paroxysmal atrial fibrillation. According to the company, the technology offers...

August 4th, 2017

WATCHMAN™ Left Atrial Appendage Closure Device

The WATCHMAN™ Left Atrial Appendage Closure Device from Boston Scientific is an implant used to block the left atrial appendage of the heart, a common area for blood clot formations in patients with atrial fibrillation. The implant, intended to reduce the risk of stroke, received FDA approval in March 2015 with an indication that covers use in high-risk non-valvular atrial fibrillation patients who want an...

August 4th, 2017

An expert addresses the opportunities for U.S. healthcare exporters in France and the trends shaping the country's healthcare market.

Curt Cultice

France, the world’s sixth largest economy with nearly 65 million people, has an aging population that is fueling demand for new healthcare technologies. While U.S. companies currently account for one-third of all medical device imports into France, there continue to be growth opportunities for U.S. healthcare suppliers. 

AVACEN, a San Diego, CA manufacturer of an over-the-counter class II medical device that provides non-invasive temporary arthritis and muscle pain relief, was searching for a comprehensive export strategy for Europe beyond its initial web sales. The company sought...

August 3rd, 2017

Developing privacy compliance strategies for new and innovative digital health tools can be challenging. Here are some key considerations for digital health technology developers.

Jennifer S. Geetter, JD and Lisa S. Mazur, JD

Historically, physicians and patients interacted within the four walls of a hospital, physician’s office, or other medical facility with minimal interaction between scheduled patient visits, except for medical emergencies. In recent years, new modalities for healthcare provider-patient interaction have significantly expanded to allow for provider and patient engagement outside of a medical facility and in the absence of an emergency. Technology-supported devices, resources, and solutions allow patients and consumers...

August 2nd, 2017

An expert describes the technical hurdles behind designing the next generation of in vitro diagnostics systems. 

Nick Collier, PhD

Ultra-sensitive diagnostic assays are used to diagnose and detect the early onset of disease. A new report by Technavio projects the global high-density multiplexed diagnostic assays market reaching $1.67 billion by 2021. According to the report, just some of the factors propelling the market to grow at a compound annual growth rate of 15% include:

  • A rise in the incidence and prevalence of autoimmune, oncology and cardiac disease;
  • ...
July 27th, 2017

Virtual reality can be used to help develop medical products people will want to use.

Andrew Sweeney

The basics of virtual reality (VR) are no secret: originally adopted by gamers, it’s a computer technology that reproduces a physical environment, allowing the user to simulate a presence in and interact with that environment. What may be a surprise, however, is its application to areas beyond gaming—including medical device development.  

Simulation in VR provides a medical device development professional with a first-person glimpse into a world experienced only from the product users’ perspective. This is important, because an empathetic understanding of end users must be maintained throughout the product development process. That impacts human...

July 26th, 2017

In the third installment in a series on women in medtech, Maria Sainz talks about the challenges and missions of her prior roles as a division president at Guidant/Boston Scientific and president/CEO of Cardiokinetix.

Maria Shepherd

Maria Sainz, former division president of Guidant/Boston Scientific and former president and CEO of Cardiokinetix, is no stranger to taking risks in her career. She started in medtech in sales and quickly became the France country manager for IVAC & Physio-Control when they were divisions of Eli Lilly. After a move to Guidant in 1995 as manager of Emerging Markets EMEAC, she rose to president of the Cardiac Surgery Unit of Guidant in 2003 and then successfully led Guidant’s Cardiac Surgery through its ...

July 25th, 2017