MDDI_Medical Device & Diagnostic Industry

MDDI, July 2016

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NewsAnalysis 10 | JULY 2016 Image courtesy of Nastco/istocKPHoto.coM NuVasive Doubles Down on Service NuVasive paid $98 million for intraoperative neurophysiological monitoring service company Biotronic NeuroNetwork. this will double the size of NuVasive's service business, adding to the intraoperative monitoring services acquired through its 2011 purchase of Impulse Monitoring Inc. NuVasive will create a division called NuVasive clinical services and expects its monitoring to be used in more than 75,000 U.s. surgical cases each year. FDA OKs First NSCLC Liquid Biopsy Test In early June, FDa announced approval of the first liquid biopsy diagnostic for nonsmall cell lung cancer (NscLc). the Roche Diagnostics test, cobas EGFR Mutation test v2, can detect epidermal growth factor receptor gene mutations in patients with NscLc. the test, which looks at specific gene mutations and substitutions, is intended as a companion diagnostic test for cancer drug tarceva. tarceva is from astellas Pharma technologies and is distributed by Genentech. Pulse Ox Without Skin Contact Possible the pulse oximeter of the future may not even need to touch the patient's skin. Royal Philips has been developing a contactless method of monitoring absolute oxygen saturation of arterial blood (spo 2 ), and new data shows that its technology works. the technology uses camera-based monitoring to determine spo 2 by measuring light reflected from patients' skin. Findings from a small study show that the new technology can be calibrated without needing to be adjusted for each patient. still, there are hurdles, like subject motion and weak pulsatile strength, to overcome. B ack in August 2015, continu- ous glucose monitoring (CGM) firm Dexcom announced that it would be partnering with Verily, for- merly Google Life Sciences, to build smaller, cheaper, disposable CGM sen- sors beefed up with analytics. "We intend to work together to de- velop simple, low-cost sensor systems integrated into advanced data analyt- ics platforms to improve diabetes care from prediabetes all the way through intensive insulin therapy," Dexcom CEO Kevin Sayer explained on the company's Novem- ber earnings call. "We expect these advances will make diabetes management much more conve- nient and flexible than ever before, and we are excited for the promise this technology holds for patients and caregivers." Now another medtech heavyweight is intend- ing to make CGM devices much for affordable for a broad swath of people. Medtronic announced in late May that it is partnering with Qualcomm Life, a subsidiary of tech company Qualcomm, to jointly develop a next-generation CGM system that will incorporate a new sensor and smaller design. These single-use, disposable CGMs would be able to provide both near real-time and retro- spective glucose data to type 2 diabetes patients. "Our vision is to transform diabetes care so people with diabetes can enjoy greater free- dom and better health," Laura Stoltenberg, vice president and general manager of nonintensive diabetes therapies at Medtronic, said in a news release. "We are thrilled to be collaborating with Qualcomm Life—a best-in-class leader in wireless technologies that is ahead of the curve in a rapidly changing connected world—to de- velop innovative and affordable CGM systems that will fundamentally change type 2 diabetes management." Type 2 diabetes patients typically stick their fingers twice a day to get glucose readings. Medtronic is a dominant player in the type 1 diabetes market, but this move corresponds with Medtronic CEO Omar Ishrak's desire to capture the much larger type 2 diabetes market segment. Ishrak made an unexpected entrance at the CES consumer electronics trade show in Las Vegas this year, sharing the stage with GE's Ginni Rometty to unveil a research prototype concept for a first-of-its-kind cognitive app that can help to detect critical patterns and trends for people with diabetes to make daily management of dia- betes simpler. That yet-to-be-released cognitive computing app offered a tantalizing possibility: In a research study of 600 patients' data that was de-identified, findings suggested that cognitive computing can predict a low-glucose event three hours before its onset. The partnership with Qualcomm is also intend- ed to enable such actionable insight, although this partnership is presumably a more R&D-intensive effort to develop a wholly new kind of CGM device that will leverage Qualcomm Life's wireless heft. That subsidiary has been hard at work in de- veloping its 2net Design platform that can design the communications components of connected medical devices, including disposable drug-deliv- ery and disposable diagnostic devices. The plat- form provides end-to-end connectivity designed to meet FDA and HIPAA safety and privacy standards. "This collaboration furthers our commitment of enabling new connected care models that lib- erate vital data and unlock insights to deliver in- telligent care wherever the patient may be," Rick Valencia, president and general manager of Qual- comm Life, said in a release. No timeline was offered regarding when such a system would be launched. In comparison, Dex- com is gearing up for its first product borne of its partnership with Google Life Sciences to launch in 2018. No matter who wins the race, if these com- panies are successful in developing approved, ef- fective products that function as advertised, the real winner may be diabetes patients. —Arundhati Parmar Heavyweight Partnerships Race Toward Next-Gen CGM

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