Integer Holdings Corporation , a leading medical device outsource manufacturer, announced it has established implantable pulse generator (IPG) clean room assembly and testing capabilities at its Tijuana-North facility to support its OEM customers.

Integer’s Tijuana-North facility is the first Class III active implantable medical device manufacturing site in Mexico to receive FDA approval. This added capacity includes Class 7 and 8 clean rooms, manufacturing facility and capital equipment investment, and provides options for meaningful future expansion. It augments the significant IPG manufacturing capacity already available at Integer’s Montevideo, Uruguay, and Plymouth, Minn., facilities, offering customers dual-site manufacturing capabilities to mitigate risk.

“Integer’s key objective is to assist OEMs in bringing their innovative therapies to market efficiently, reliably and cost effectively.” said Joel Becker, president of Integer’s Cardiac Rhythm Management and Neuromodulation business. “This regulatory approval and facility expansion help us offer our customers expanded capacity and flexibility.”

The site is supported by onsite engineering and technical as well as operational staff members trained from Integer’s Research and Development Center of Excellence for IPG. Additional in-house facility capability will be in place in the Tijuana-North facility by mid-2020.

The expansion will allow customers to continue to benefit from Integer’s vertically integrated supply chain for critical IPG components, including batteries, feedthroughs and enclosures, some of which are also manufactured in the Tijuana-North facility.

“We continue to make strategic investments to support our customers’ growth and advance us toward our vision of being our customers’ partner of choice for innovative medical technologies,” said Becker. “Integer’s goal is to offer best-in-class quality, service and value, and support our customers with the most comprehensive design, development and manufacturing services available for Class III medical device systems.”

Production is managed under Integer’s Manufacturing Excellence strategies, and the manufacturing cell layout design was developed under the guidance of Integer’s Lean Center of Excellence.

About Integer ^®

Integer Holdings Corporation (NYSE:ITGR) is one of the largest medical device outsource (MDO) manufacturers in the world serving the cardiac, neuromodulation, vascular, portable medical, advanced surgical and orthopedics markets. The company provides innovative, high-quality medical technologies that enhance the lives of patients worldwide. In addition, it develops batteries for high-end niche applications in energy, military, and environmental markets. The company’s brands include Greatbatch™ Medical, Lake Region Medical™, and Electrochem™.

Quest Diagnostics , the world’s leading provider of diagnostic information services, announced that it has acquired Blueprint Genetics in an all-cash equity transaction. Blueprint Genetics is a leading specialty genetic testing company with deep expertise in gene variant interpretation based on next generation sequencing (NGS) and proprietary bioinformatics. Together, Quest and Blueprint Genetics will broaden access to actionable insights in genetic and rare diseases, improving patient care and pharmaceutical drug research and development. Financial terms of the transaction were not disclosed.

“The great challenge with genetic testing is generating quality, actionable and broadly accessible insights from vast quantities of sequenced genetic data,” said Steve Rusckowski, Chairman, President and CEO, Quest Diagnostics. “Blueprint Genetics has developed a proven model for delivering highly specialized genetic insights that we believe we can scale to serve new patient populations with unmet clinical needs. The addition of Blueprint Genetics strengthens and extends the Quest value proposition in genetics, delivering on our Accelerate growth strategy and vision of a healthier world.”

Founded in 2012, Blueprint Genetics grew rapidly, and now serves customers in over 70 countries. The company’s growth is based largely on proprietary guideline-supported methods of gene variant interpretation of data generated from next generation sequencing, backed by high-touch consultative service. The company provides 3,900 targeted single gene and over 200 panel tests spanning 14 medical specialties. Gene variant interpretation involves identifying associations between gene variants and disease or treatment response.

Blueprint Genetics has increased its focus and presence in the United States through a recently established hub facility in Seattle, Washington. The acquisition provides a platform for Blueprint Genetics to leverage Quest’s capabilities in next generation sequencing and national infrastructure serving half the health systems and physicians in the United States. Blueprint Genetics is expected to continue to operate largely independently from its base laboratory in Helsinki, Finland, and a presence in other countries.

Through its Advanced Diagnostics offerings, Quest specializes in combining state-of-the-art technologies, such as next generation sequencing, with higher-order interpretative expertise and digital customer enablement. Blueprint Genetics brings to Quest high-touch service in variant interpretation and reporting and associated sequencing and bioinformatics, which complement and extend its existing genetics leadership.

“As the leader in Advanced Diagnostics, Quest Diagnostics understands that robust bioinformatics and consultative expertise are essential to fast, accurate and cost-efficient data interpretation,” said Carrie Eglinton Manner, Senior Vice President, Advanced Diagnostics, Quest Diagnostics. “Blueprint Genetics brings to Quest a proven platform in specialty genetics — especially gene variant interpretation and reporting — that powerfully differentiates our Advanced Diagnostics offering.”

Over time, the acquisition is expected to yield new capabilities to serve providers specializing in rare disease and neurology, particularly pediatric and academic hospitals. The two organizations also envision that members of the Quest Diagnostics Global Diagnostic Network and its pharmaceutical and in vitro diagnostic collaborators will benefit from Blueprint Genetics’ capabilities.

“Blueprint Genetics prides itself on resolving the most challenging genetic and rare disease cases to improve patient outcomes,” said Tommi Lehtonen, who has agreed to continue to lead the company as Vice President and General Manager, reporting to Ms. Eglinton Manner. “Teaming up with Quest will allow us to extend our capabilities in the United States as well as in Canada and other countries where we already have strong and growing client relationships. While we considered joining forces with several organizations, Quest’s genetics leadership, national infrastructure and strong cultural fit made it the perfect partner from which to extend our reach to new providers and patients.

Genetic testing can aid in diagnosing many rare diseases as well as identifying future risk of and treatment for certain cancers and other conditions. According to the National Institutes of Health, as many as 7,000 rare diseases exist and as many as 30 million Americans have a rare disease.

About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world’s largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 46,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives.

Bardy Diagnostics, Inc , a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced the commercial launch of the 14-Day version of the Carnation Ambulatory Monitor , the industry’s only P-wave centric ambulatory cardiac patch monitor and arrhythmia detection device, following recent clearance by the FDA.

BardyDx Carnation Ambulatory Monitor – P-wave centric ambulatory cardiac patch monitoring and arrhythmia detection (PRNewsfoto/Bardy Diagnostics, Inc.)

“The 14-Day CAM is the culmination of years of development focused on uncovering the full complexity and meaning of a patient’s cardiac rhythm,” said Gust H. Bardy, MD, Founder and Chief Executive Officer of BardyDx. “We are proud to develop and introduce the most advanced and accurate cardiac monitoring technologies that enable new opportunities to reimagine and redefine patient care.”

The significance of the CAM Patch’s P-wave centric clinical value was highlighted in the American Heart Journal that published the results of a head-to-head comparison with the iRhythm Zio® XT patch, concluding that the BardyDx CAM Patch identified 40% more arrhythmias and resulted in better, more informed clinical decision-making in 41% of patients over the iRhythm Zio XT patch. In addition, a preceding study also published in the American Heart Journal comparing the CAM Patch and a traditional Holter monitor, showed a four times increase in arrhythmia detection using the CAM Patch, including arrhythmias missed or incorrectly identified using the Holter monitor, concluding that the CAM Patch offered significantly improved rhythm diagnostics.

Strong market uptake of BardyDx’s P-wave centric solutions has spurred recent expansion of the company’s infrastructure to maintain its rapid pace. A second ECG monitoring center located in New Jersey was established last quarter, which received Medicare enrollment approval by the Centers for Medicare & Medicaid Services effective December 2, 2019. In addition, BardyDx recently announced the addition of medical device industry veteran, Ed Vertatschitsch, as Chief Operating Office, along with several new vice president appointments to strengthen the Leadership Team.

“We are extremely proud of the continued momentum of the CAM Patch becoming the cardiac monitor of choice and trusted solution of cardiologists and electrophysiologists across the U.S., U.K., and Canada,” said Ken Nelson, Chief Commercial Officer. “It is increasingly clear that customers are realizing the true clinical and market-differentiating value of our P-wave focused detection technology in enabling optimal patient care.”

The growing market recognition of the innovative P-wave centric CAM Patch includes recently being selected as winner of the Remote Monitoring in Arrhythmias Digital Health Pitch Session at European Society of Cardiology Congress 2019 and finalist of the UCSF Digital Health Award for Best Cardiovascular Digital Diagnostic. In addition, BardyDx was also named the winner of the 2019 MedTech Breakthrough Award for Best New Diagnostic Technology and the winner of the 2019 Frost & Sullivan Award for Technology Innovation in Remote Cardiac Monitoring.

About Bardy Diagnostics:

Bardy Diagnostics, Inc. is an innovator in digital health and remote patient monitoring, with a focus on providing the most diagnostically-accurate and patient-friendly cardiac monitors to the industry. The company’s CAM Patch is a non-invasive, P-wave centric™ ambulatory cardiac monitor and arrhythmia detection device that is designed to improve patient compliance for adults and children through its lifestyle-enabling form factor. Designed to be worn comfortably and discreetly for up to 14 days, the female-friendly, hourglass-shaped CAM Patch is placed on the center of the chest, directly over the heart for optimum ECG signal collection. The proprietary technology of the CAM Patch provides optimal detection and clear recording of the often difficult-to-detect P-wave, the signal of the ECG waveform that is essential for accurate arrhythmia diagnosis.

Hg, the specialist private equity investor focused on software and service businesses, announces that it has finalized an agreement for an investment in Intelerad Medical Systems , a leading global provider of medical imaging software and enterprise workflow solutions. The terms of the transaction are not disclosed. The transaction is expected to close in the first quarter of 2020, following satisfaction of customary regulatory approvals.

Founded in 1999, Intelerad is a medical imaging software provider that specializes in diagnostic viewing, reporting and collaboration solutions for radiologists. Headquartered in Montreal (CA), Intelerad has over 400 employees located in various offices in Canada, the United States, the United Kingdom, and Australia. The company serves over 300 healthcare organizations around the world, including radiology groups, imaging centers, clinics and reading groups, and has a strong and growing presence in hospital imaging departments. Intelerad was awarded Best in KLAS recognitions, ranking #1 for PACS Canada and #1 for PACS Asia/Oceania in the 2019 Best in KLAS: Global Software (Non-US) report.

Hg recognizes Intelerad’s leading role in supporting radiologists globally to deliver highly accurate diagnoses at optimum productivity. The business is a key enabler of healthcare delivery against a backdrop of increasing global demands, in radiology, for scalable and more efficient imaging, data management and workflow solutions. Intelerad is led by a highly-talented team who have developed powerful solutions for radiologists, offering both efficiency and a premium service that helps create superior outcomes for both patients and healthcare providers.

Healthcare technology is a core sector for Hg, with an investment focus on healthcare operations, core systems, life sciences digitization, interoperability and population health. Intelerad represents the 5th healthcare technology investment in Hg’s current portfolio, joining Rhapsody + Corepoint, a global leader in healthcare interoperability and data liquidity solutions; Allocate Software, a global provider of healthcare workforce and risk management software; Evaluate, which supplies mission-critical commercial information to the pharmaceutical industry globally; and Medifox, which provides software solutions to ambulatory care services, elderly care homes and therapists.

Hg’s investment will be made from the Hg Genesis 8 Fund and represents the firm’s first investment in Canada and second investment led by the New York office, since opening in 2019. The Hg team was led by Gero Wittemann, Hector Guinness, J-B Brian and David Issott.

Under the terms of the agreement, Hg will acquire Intelerad from Novacap’s TMT IV Fund, and its founders, management and employee shareholders who will all be re-investing into the business alongside Hg and Ardan.

Paul Lepage, Chief Executive Officer at Intelerad, said: “Partnering with Hg gives us access to a huge pool of knowledge in global healthcare technology and the opportunity to significantly advance the company’s strategy. We are thrilled to continue making a difference in healthcare with such talented people. As well as welcoming our new investors, I also thank the Novacap team and our colleagues who all worked so hard to get us into this strong position, as well as our customers for their continued trust over the last 20 years. Looking forward to exciting times ahead.”

Gero Wittemann, Partner and co-lead of Hg’s New York team, commented: “Intelerad has a winning platform that creates significant efficiencies for healthcare organizations, while adding true value to help radiologists and other physicians view, interpret and share medical images. We fully embrace Intelerad’s vision in making a sustainable difference in healthcare and it’s particularly exciting to join Paul and the team at this stage in the company’s journey. We will look to leverage our experience in healthcare technology and our operational experts to support the business strategy through innovation and operational excellence.”

Hg were advised on the investment by Tripletree, Bain, Marwood, EY and White & Case.

PENTAX Medical, a division of the HOYA Group, announced that it has cleared CE mark for DISCOVERY™, an innovative Artificial Intelligence (AI) assisted polyp detector designed to support endoscopists in finding potential polyps during a colorectal examination.

DISCOVERY™ is the outcome of a close cooperation between PENTAX Medical research center located in Augsburg, Germany, and expert clinical partners from six of the leading medical institutions across the world. For this next generation development, a total of more than 120,000 files from approximately 300 clinical cases were used for the software training. By this, DISCOVERY™ is able to assist with the detection of potential polyps in real time.

The system is built in a flat monitor to provide a high usability as it can be used with any of PENTAX Medical video endoscopy systems to highlight potential polyps. The menu is self-explaining and uses an intuitive touchscreen interface.

“The benefits for the customers are outstanding. Our vision was to bring Artificial Intelligence into the operating room in the most user-friendly way. We wanted to give doctors the possibility to use this exciting new technology to strive for a better clinical outcome and maximize the patient care”, Mr. Wolfgang Mayer, Managing Director. R & D, PENTAX Medical Augsburg mentioned.

PENTAX Medical is committed to continuously exploit the use of Artificial Intelligence in additional medical fields. By gradually enhancing the product line up, PENTAX Medical has dedicated themselves to leverage AI for the further support of customers and patients.

Prof Timo Rath, Professor of Endoscopy and Molecular Imaging, University of Erlangen, Nuremberg, Germany mentioned, “As endoscopists one of our major tasks is to reduce the incidence of colorectal cancer. I’m very confident that the DISCOVERY™ will translate into increasing our own Adenoma Detection Rate and therewith will contribute to reduce colorectal cancer mortality”.

PENTAX Medical plan to launch in the first markets in spring 2020.

About PENTAX Medical

PENTAX Medical is a division of HOYA Group. The company’s mission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on QUALITY, CLINICALLY RELEVANT INNOVATION, and SIMPLICITY.

Through providing endoscopic imaging devices and solutions to the global medical community and with its headquartered in Japan, PENTAX Medical has a worldwide focus and a strong presence with R&D, regional sales, service, and in-country facilities in multiple regions around the globe.

PENTAX Medical’s Triple Aim program strives to deliver on the commitment to support its customers and their healthcare organization’s wider objectives through a transparent partnership and by providing the highest quality solutions to help them reach their goals. Enabling customers to improve patient outcomes by offering evidenced based solutions across the continuum of care, dedicated to their needs. From screening through to therapy with full scalabilities. Ensuring values by supporting the customers to improve their efficiency and minimize their healthcare costs. Enriching patient and provider’s experience by empowering every member of the care team to achieve optimal outcomes through products, education and support.
For more about PENTAX Medical, please visit www.pentaxmedical.com