A Medical Device Daily

LMS Medical Systems (Montreal), developer of the CALM clinical information system and risk management software tools for obstetrics, reported the availability of the first version of CALM Patterns, a risk management software tool specifically directed at the health of the fetus.

LMS said that fetal distress during labor “is recognized as one of the greatest complexities of childbirth and therefore a significant issue insofar as risk management is concerned.” It said that during labor and delivery, medical professionals review fetal heart rate tracings looking for indications of fetal distress, adding that “failure to recognize and respond to abnormal fetal heart rate patterns in a timely manner can lead to a number of serious complications for the fetus and is a common problem in birth-related brain injury.”

The company said it has created a real-time software tool that can, “on a heartbeat-to-heartbeat basis, constantly analyze and present updated information to medical teams to assist in the identification of significant fetal distress.”

It said CALM Patterns achieves that goal by using specialized algorithms and neural networks that detect, label and measure patterns in fetal heart rate recordings at the bedside during labor.

LMS risk management tools have been designed to provide clinicians with an objective, real-time bedside means to more clearly, accurately and proactively assess patient safety, improve situational awareness and reduce risk,” said Emily Hamilton, MD, vice president of medical research for LMS. “The ability to assess the baby’s tolerance to labor, along with better recognition of fetal distress, can help reduce the incidence and severity of birth-related brain damage.”

The company said its CALM Suite “provides physicians, nursing staff, risk managers and hospital administrators with obstetrics clinical information systems and risk management tools designed to improve outcomes and patient care for mothers and their infants during childbirth.”

Aurora in collaboration with China group

The Aurora Breast MRI Society (ABMS; North Andover, Massachusetts) reported what it termed a “groundbreaking” collaboration with the China Medical Women’s Association (CMWA) aimed at improving breast cancer care in China and the U.S.

A professional exchange program is the first curriculum being developed for the collaboration, under which research specialists from China will be sponsored to spend two to three weeks in leading comprehensive breast centers in the U.S. to learn about breast imaging modalities and their use in the detection, diagnosis and treatment monitoring of breast cancer.

Aurora Imaging Technology (North Andover) has committed as the first corporate underwriter of the program.

“Breast cancer is emerging as the leading cancer for women in China,” said Dr. Zi-yang Li, executive vice president of CMWA. “The challenge in China, with our high percentage of women with dense tissue, is to develop an effective way to earlier detect and better diagnose breast disease.”

“There is an urgent need for more advanced breast imaging technologies among women in Asia, as breast cancer is now the leading cause of cancer death in women,” said Olivia Ho Cheng, president and CEO of Aurora Imaging. “The objective ... in forging this relationship is to [introduce] Asian physicians ... to the most advanced technologies available, then return them to their own professional communities to educate other providers.”

Expanded distribution accord in Panama

BioElectronics (Frederick, Maryland) said that its plastic surgery distribution agreement with VitalMedic in Panama has been expanded to other medical specialties. The U.S. firm said initial product shipments this summer have been “enthusiastically received” by plastic surgeons.

ActiPatch is a drug-free, anti-inflammatory patch with an embedded battery-operated microchip that delivers weeks of continuous pulsed therapy to reduce soft-tissue pain and swelling.

VitalMedic is a medical distributor that represents Integra, Applied Medical, Mentor, W.L. Gore and other companies, including BioElectronics, for medical specialties and hospital environments.

“During my recent visit to BioElectronics, I was [pleased] to learn that ActiPatch has a much wider range of application than just plastic surgery. With this in mind, and based on the reception of ActiPatch by the plastic surgeons [in Panama], we have initiated an expansion of our sales to most post-surgical care, orthopedics, sports medicine, foot care, and the retail target healthcare market,” said Gabriel Icaza, president of VitalMedic.

“With their understanding of the importance of innovative medical devices and their enthusiasm for ActiPatch, VitalMedic will bring a vibrant approach to the introduction of the healing benefits that are derived from ActiPatch,” said Andrew Whelan, president of BioElectronics.

Malaysian facility gets FDA okay

Plexus (Neenah, Wisconsin), a contract manufacturer of electronics products, reported that one of its facilities in Penang, Malaysia, has received approval from the FDA, through its pre-market approval (PMA) supplement evaluation process, to manufacture Class III finished devices on behalf of a large medical OEM.

The approval comes following an extensive on-site audit by the FDA in Penang.

CEO Dean Foate said, “This is another significant milestone in our more than 20-year history of supporting the increasingly global outsourcing requirements of medical device OEMs. Plexus has three FDA-registered manufacturing facilities — in the U.S., Mexico and Malaysia — of which two now are approved to manufacture finished Class III medical devices.”

He added that about one-quarter of the company’s annual revenues now come from product design, supply chain management and manufacturing services for medical device OEMs.

Andy Hyatt, vice president of Plexus’ Medical Sector, added, “We believe Plexus is one of the first contract manufacturers to have an Asian facility with FDA approval to manufacture finished Class III medical devices. We ... expect to be registering additional facilities in Malaysia and the UK with the FDA over the coming year.”