InfoBionic’s CE mark for MoMe system

Remote patient monitoring for cardiac arrhythmias is the first universal platform with seamless transition between Holter, Event, & MCT modes.

January 13, 2014
Manufacturing Group

Automation/Robotics Industry/Regulations Contract Manufacturing Design/Engineering Devices/Implants/Equipment People/Facilities

InfoBionic, an emerging digital health company focused on creating superior patient monitoring solutions for chronic disease management, today announced receipt of CE Mark for the MoMe system for cardiac arrhythmia monitoring. The MoMe system is the first universal remote patient-monitoring platform with seamless transition between Holter, Event, and Mobile Cardiac Telemetry (MCT) modes. The innovative platform, which leverages Cloud computing and proprietary analytics, is poised to revolutionize the $3B worldwide cardiac monitoring market by delivering on-demand access to patient data for diagnosis.

The MoMe Ssystem draws on the recent convergence of medical devices, database analytics, new sensors, and wireless protocols to provide a universal patient monitoring platform complete with real-time, high-quality patient data for improved arrhythmia detection.

"Existing cardiac patient monitoring systems have significant limitations, including poor data quality and limited data availability," stated Liviu Klein, M.D., UCSF Heart and Vascular Center. "The MoMe system provides high-quality data and real-time rhythm history as well as activity, respiration and symptom tracking that allows me to make a fast, accurate, timely and efficient medical diagnosis."

Nancy Briefs, CEO, commented, "We are pleased to receive CE Mark for the MoMe system. We believe the system will transform the arrhythmia monitoring market by offering superior arrhythmia detection and favorable physician practice economics. We look forward to commercializing our first product for cardiac arrhythmia monitoring in early 2014."

Source: InfoBionic Inc.

FDA clearance for new bedside monitor

EarlySense’s newly designed bedside monitor launched in the US and will soon be available in Asia and Europe.

January 13, 2014
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Contract Manufacturing Design/Engineering Devices/Implants/Equipment Industry/Regulations People/Facilities

EarlySense, the market leader in proactive patient care solutions, announced that the company has received FDA Clearance for EarlySense 2.0 System, a newly designed bedside monitor for continuous measurement of respiration rate, heart rate and motion, in an automatic and contact-free manner.

"The newly designed Bedside Monitor is in line with EarlySense's constant focus on innovation and patient care improvements," said Dalia Argaman, VP of Clinical and Regulatory Affairs at EarlySense. "We provide the clinical team access to actionable information and empower them to identify potentially critical situations and respond in a proactive manner, in the hopes of preventing an adverse event from occurring as well as assisting the clinical team to become more efficient."

EarlySense is also enhancing its focus on quality assurance tools and benchmark analysis reports to provide sophisticated management tools that will allow hospital leaders to set quality goals, measure their results, drive staff behavior towards improvement and achieve their objectives. For example, providing the capabilities to measure staff response times to bed exit alerts, and then reviewing reports with staff has allowed several institutions to improve their response times, and thus reduce fall rates.

Avner Halperin, CEO of EarlySense added, "EarlySense plans to present a new product line to the market in the first quarter of 2014 that will address hospitals' needs for better patient supervision. The new product line will include safety focused product, addressing falls and pressure ulcers prevention, as well as EarlySense Respiratory and Heart Rate monitoring capability for early detection of patient deterioration."

Source: EarlySense

Toyoda Machinery USA adds new distributor to SE region

Adept Machine Tools will serve the Carolinas, Va., and WV.

January 13, 2014
Manufacturing Group

People/Facilities

Toyoda Machinery USA has added Adept Machine Tools Inc. to its distributor network. Serving the Carolinas, Virginia, and the southern part of West Virginia, Adept Machine Tools is the exclusive Toyoda distributor for the region.

Based in Troutman, N.C., this full service distributor will carry Toyoda’s extensive lineup of horizontal and vertical machining centers, grinding machines, bridge- and gantry-type mills, vertical turning centers, and automation solutions.

“We are very pleased with the new partnership with Toyoda Machinery. Toyoda’s reputation for quality, performance, and reliability matches Adept’s strategic goal to focus only on the best products for our customers in North Carolina, South Carolina, and Virginia,” said Chuck Schiefen, president of Adept.

In addition to providing sales and service support to its customers, Adept Machine Tools specializes in application engineering solutions and product training. Adept Machine Tools’ 4,000ft2 showroom currently houses a Toyoda vertical machining center.

Source: Toyoda Machinery USA

Encision files 510(k) with FDA for AEM simplification product

The EndoShield integrates Encision's patented AEM technology into a disposable smart cord and eliminates the need for a separate AEM monitor.

January 13, 2014
Manufacturing Group

Contract Manufacturing Design/Engineering Devices/Implants/Equipment Industry/Regulations People/Facilities

Encision Inc., a medical device company owning patented surgical technology that prevents stray electrosurgical burns in minimally invasive surgery, has filed a premarket notification under Section 510(k) with the FDA of its intent to market what has previously been described as an AEM simplification product, and is now called the EndoShield Burn Protection System (EndoShield).

The EndoShield integrates Encision's patented AEM technology into a disposable smart cord and eliminates the need for a separate AEM monitor. The EndoShield eliminates the risk of stray energy burns to patients and provides an intuitive, elegant interface for the user. The device recently received approval from an independent testing agency for IEC 60601-1 electrical safety testing and a 510(k) application was submitted to the FDA last week.

"The EndoShield is a major evolution of our AEM monitoring system," said Greg Trudel, president and CEO of Encision. "Marketing evaluations of the EndoShield have been conducted in several major U.S. markets, and it has received an overwhelmingly positive response from the nurses and physicians who participated, particularly regarding comments on the simplicity and ease of use of the device. We expect that this product will launch in the Spring of 2014."

Source: Encision Inc.