Boston Scientific CEO Mike Mahoney said the company is excited to become the founding medical device partner in the effort, Optum Labs, and “to collaborate with other healthcare leaders to help accelerate the pace of innovation across our industry.” Boston Scientific has about 24,000 employees, 5,000 of them in Minnesota.
O'Fallon, Missouri – For more than 10 years, the Directional Laser Probe has been Synergetics' signature product. Synergetics is a medical device company that designs, manufactures, and markets innovative surgical devices for ophthalmic and neurosurgical applications.
The patented Directional Laser Probe can be straight when entering the eye, eliminating the risk of bumping the natural lens, as well as the ability to work around the posterior pole when applying laser treatment. It also features the ability to curve, which is extremely beneficial when the surgeon needs to reach the periphery of the eye.
The Directional II Laser Probe is a significant improvement on the original Directional Laser Probe and incorporates years of feedback from the original design. These improvements include an ergonomic, color-coded handle that emulates the Synergetics Pinnacle instrument line. In addition, it incorporates significant improvements on the mechanism responsible for adjusting the fiber from straight to curve, converting it to a more natural roller mechanism to ensure a smooth actuation. With this, surgeons are able to remove pressure from the roller mechanism with confidence that the device will not adjust on its own due to the intraocular pressure.
"These improvements provide for a higher quality and a more user friendly laser probe," stated Dave Hable, president and CEO of Synergetics USA, Inc. "Our new Directional II Laser Probe demonstrates our commitment to the laser probe product line and sets us apart from the competition. We look forward to its immediate release and benefit to the surgeon community."
Source: Synergetics USA Inc.
Dallas, Texas – AccelSPINE received FDA clearance on its Picasso II system, which is designed to enhance the spinal implant experience for surgeons and patients.
"Picasso II is the next generation of minimally invasive spine systems. It incorporates an easy-to-use, double-lead thread, and self-tapping screw with an innovative rod-delivery system to increase implant efficiency," stated Daniel Chon, AccelSPINE president and CEO.
Picasso II is intended to immobilize and stabilize spinal segments in skeletally mature patients as a supplement to fusion during the treatment of acute and chronic instabilities or deformities of the upper or lower spine, or the sacral (tail-bone) region. The system is a continuation of the Picasso product line – Picasso I received FDA clearance in 2012. Picasso I is a minimally invasive system featuring a broad selection of screw/rod delivery instruments and implants.
"The difference between Picasso I and Picasso II is the double-lead thread and self-tapping, anodized screw that streamlines the implant process. This is an evolutionary system that was designed based on input from our surgeons. We continually ask our surgeons for feedback on our products so that we can bring to market the best and most innovative products possible," said Estella Baytan, vice president of marketing and clinical operations for AccelSPINE.
Minimally invasive spine surgery vs. open-back
Minimally invasive spine surgery is designed to utilize smaller incisions and special tools in hopes of reducing tissue damage. Minimally invasive options may result in fewer or smaller scars, reduced blood loss, less pain and a shorter recovery time for patients than they would have experienced with traditional, open-backed surgery. In addition, minimally invasive surgery has been reported to "minimize cutting to muscles, tendons and other normal tissues that aren't directly involved with the back disorders."
Brazil will begin hosting soccer’s 2014 World Cup, even though workers are still hurrying to pour concrete at three unfinished stadiums. At a laboratory in São Paulo, a Duke University neuroscientist is in his own race with the World Cup clock. He is rushing to finish work on a mind-controlled exoskeleton that he says a paralyzed Brazilian volunteer will don, navigate across a soccer pitch using his or her thoughts, and use to make the ceremonial opening kick of the tournament on June 12.
Needham, Massachusetts – PTC officials announce the successful submission of UDI data to the preproduction version of the U.S. Food and Drug Administration's Global Unique Device Identifier Database (GUDID) through the Electronic Submission Gateway (ESG) in the required HL7 SPL format. The FDA's UDI rule aims to dramatically reduce the instances of patient injury and death that result from the misidentification of medical devices.
The FDA's first UDI compliance deadline for high-risk Class III devices is Sept. 24, 2014. High-risk devices are identified as the most complex life-sustaining medical devices like pacemakers, defibrillators, vascular stents, and ventilators. Medical device manufacturers need to implement compliant processes and technology to meet the UDI requirements and avoid any potential negative consequences.
According to Jay Crowley, vice president of UDI practice at USDM Life Sciences, "It's important that device companies have a solution that's fully capable of meeting current FDA GUDID requirements, while also being scalable and flexible for future global UDI requirements. The PTC UDI Solution enables medical device manufacturers to submit the appropriate records to the FDA's GUDID."
PTC worked with the FDA and major medical device manufacturers to develop a GUDID submission solution. Built on the PTC Windchill platform, the PTC UDI solution is a preconfigured, enterprise software solution designed to help medical device manufacturers meet the needs of UDI submissions as quickly and effectively as possible. The solution is fully validated in accordance with 21 CFR Part 11 requirements and enables manufacturers to gather, submit and track GUDID data.
The PTC UDI Solution enables manufacturers to:
- Communicate and track GUDID submission data, managing the electronic relationship with - including responses from - the FDA's GUDID and tracking submissions across product lines to ensure enterprise-wide compliance.
- Govern GUDID submissions in accordance with FDA regulations, enabling customers to oversee and control the status and progress of all submissions across product lines within a 21 CFR Part 11 compliant solution including software validation, training and electronic data management.
- Manage and synchronize changes to GUDID submissions through robust software architecture to easily manage large sets of similar data as well as ensure that product changes in upstream data stores kick off new or revised GUDID submissions to meet ongoing compliance needs.
"The only real certainty with GUDID compliance is that global requirements will likely change. Continuing compliance will require a practical solution that's fully capable of meeting all current UDI regulations for submission data, and fully scalable to support the many more global UDI requirements anticipated for the future," said Mark Hodges, division general manager, PLM segment, PTC. "The PTC UDI Solution delivers accuracy, scalability, and quick response times for GUDID compliance initiatives."