Medical Devices Today

China Hopes To Implement Unique Device Identifier System By Year End

Article preview from "The Gray Sheet"- March 21, 2014

China has been talking about implementing a UDI system to track distribution of medical devices for years. Former CFDA and U.S. FDA experts now suggest that China plans to implement such as system by year end.

Will Stryker’s MAKO Purchase Bring Disruption To The Ortho Industry?

Article preview from Medtech Insight Newsletter - October 28, 2013

Stryker’s adoption of MAKO’s RIO (Robotic-arm Interactive Orthopedic) system could give the global medical supplier a competitive edge over other orthopedic implant makers if the company can win converts to robotic surgery by leveraging its own experience in selling capital equipment.

Toward Spectacle-Free Cataract Surgery

Article preview from Start-Up - December 18, 2013

After a lull, or at least a single-minded focus on femtosecond lasers for a time, refractive surgery has gotten exciting again: the drive to spectacle-free outcomes for cataract patients (who have aged-out of their eligibility for other refractive procedures) is calling for solutions that offer precision and accuracy at every stage of treatment. Start-ups coming up with the solutions will be serving some gigantic markets.

Medtech 2013: Device Companies Go Where The Growth Is

Article preview from IN VIVO - January 27, 2014

To stave off the sluggish growth in established markets, multinational medtechs not only are finding new business in countries with booming health care industries but they’re also forging new ways to serve customers. Device companies now are pushing into services, such as disease management, and angling to compete more aggressively on pricing.

CDRH’s Owen Faris: New Clinical Trials Program Will Speed Up IDE Approvals

Article preview from "The Gray Sheet"- March 12, 2014

In an interview with “The Gray Sheet,” CDRH’s Acting Clinical Trials Director Owen Faris discusses the device center’s new pre-market clinical trials program aimed at speeding up approval times for investigational device exemptions and increasing the number of IDE trials in the U.S.

BioVentrix: Reshaping Heart Failure

Article preview from Medtech Insight Newsletter - October 23, 2013

BioVentrix Inc. is developing a unique, minimally invasive approach to reshaping the heart’s scarred and enlarged left ventricle aimed at patients who develop ischemic heart failure following a heart attack. The company has made considerable headway with its technology, which offers an interesting balance between a catheter-based and surgical-based procedure; however, CEO Kenneth Miller, well aware of the pitfalls that have plagued earlier companies in this field, is taking a cautious approach to the US market.

 

Cerora Inc.

Article preview from Start-Up - November 2013

Cerora Inc. has developed a concussion assessment platform that will collect and analyze many different types of inputs: EEG data, eye gaze measurements, and measures of cognition and voice analysis, to detect concussions. By doing so, the company thinks it will be able to provide a more comprehensive picture of brain injury than competitors whose technologies assess a single factor.

Battling Infection: Hospitals Seek High-Tech Solutions

Article preview from IN VIVO - January 29, 2014

The market for diagnostic and infection control products will see continued growth as hospitals and other providers look to the technology sector to help fight the battle against health care-associated infections and antibiotic-resistant organisms.

Obama Budget Seeks Prior-Authorization Ability For All Medicare Fee-For-Service Items

Article preview from "The Gray Sheet"- March 4, 2014

The administration’s March 4 budget request, repeats past attempts to expand prior-authorization requirements for power wheelchairs and advanced imaging, while also giving CMS the authority to institute prior-authorization for all Medicare fee-for-service items.

Cooling The Brain: New Therapies For Stroke

Article preview from Medtech Insight Newsletter - October 2013

Therapeutic hypothermia has shown promise as a neuroprotective treatment for a variety of applications, including cardiac arrest and neonatal hypoxic brain injury. Now companies with temperature management technologies are conducting clinical trials and developing new cooling devices with an eye toward cooling the brain in patients who experience an acute ischemic stroke – an indication with an estimated worldwide market potential of $3 billion annually.