Global Kinetics Corp. is taking a more personalized approach in monitoring Parkinson's disease symptoms. The Melbourne, Australia-based company has developed its Parkinson's Kinetigraph (PKG) system, an approved device that sits firmly in the digital health space. Recently, the private company secured a CE mark for the second generation of the PKG. The second generation system boasts technological enhancements that could ultimately allow patients to continuously monitor their condition. "PKG is a patient friendly algorithm based system," Timothy Still, president and CEO of Global Kinetics, told Medical Device Daily. "It has a smart watch that records...

SAN FRANCISCO – Diagnostics specialist T2 Biosystems Inc. is looking to add a new product to its sepsis detection offerings. The Lexington, Mass.-based company spoke with Medical Device Daily, during the 35th annual J.P. Morgan Healthcare Conference to discuss the product, which will detect the bacterial species associated with sepsis. T2' s president and CEO John McDonough said the company would be in a position to seek approval for the T2bacteria Panel this year. "From our standpoint the bacteria panel works the same way as our other sepsis detection panels work in measuring what happens...

SAN FRANCISCO – Wall Street isn't happy with oncology med-tech Novocure Ltd. The St. Helier, Jersey-based company is working to secure Medicaid reimbursement for its FDA-approved glioblastoma indication – and to move into other solid tumors – all while working to breakeven on its cash in hand. Investors remain skeptical, having driven Novocure's valuation down by more than two-thirds since its IPO in October 2015 – and off 10 percent in just the first few weeks of this year. It's offer price at IPO was $22, but since then shares have descended to almost $7....

SAN FRANCISCO – A panel spanning regulator, payer, provider and academic interests celebrated the rapid proliferation of diagnostics based on emerging kinds of data that could enable more precise, earlier and better patient treatment. Starting with genomics, this data intensity has rapidly proliferated into all sorts of 'omics analyses, including proteomics, pharmacogenomics, metabolomics and microbiomics. Much of this work remains at the research stage, but panelists from the FDA, the Mayo Clinic, the Blue Cross Blue Shield Association and San Diego-based Illumina Inc. spinout Grail Inc. mused on various issues facing this part of the...

SAN FRANCISCO – Boston Scientific Corp. said its bid to bring its Lotus Edge transcatheter aortic valve technology (TAVR) to the U.S. will continue as planned. During a Tuesday breakout session at the 35th annual J.P. Morgan Healthcare conference, the company said the issue had been resolved. Boston Scientific also noted it wasn't a design flaw in the device nor were there any safety issues. The firm said a fix to Lotus Edge required a combination of "minor process and specification changes", rather than any meaningful, costly and lengthy product redesigns. News of the firm's...

As technology has advanced – and overlapped – in the life sciences and information technology spaces, it has created a nexus in which areas such as math, physics, computing, chemistry and biology intersect. And that intersection is the focus of Digitalis Ventures, which launched a new $100 million fund aimed at investing in health solutions. "It's really a coming together of these different technology realms," Digitalis founder and managing partner Geoff Smith told Medical Device Daily. "We're really interested in thinking about health, rather than thinking about disease, and [inverting] the common thinking in the health care space." It's a...

SAN FRANCISCO – Edwards Lifesciences Corp. said it's doubling down on a plan to be successful in the transcatheter mitral valve replacement (TMVR) market. The Irvine, Calif.-based company laid out what said is its 'shots on goal' strategy to penetrate the TMVR space, during the 35th annual J.P. Morgan Healthcare Conference. The increased focus on TMVR has been dubbed by some analysts as the 'second act' for Edwards, which has already established a leading position in the transcatheter aortic valve replacement (TAVR) space. "It will be Edwards' progress in mitral and transcuspid therapy that gives...

Early cancer screening start up Grail Inc. could raise more than $1 billion in a series B round, making it in one of the largest financings in med-tech history. Grail said the funding would be used to develop a blood-based test for cancer screening. In addition, part of the funding would be used to repurchase a portion of Illumina Inc.'s stake in Grail. The San Diego-based company launched Grail almost a year ago. (See Medical Device Daily, Jan. 12, 2016.) Since that time, Grail has taken in $100 million in a series A round from...

There's no question that both 2015 and 2016 were blockbuster years for surgical sealant maker Cohera Medical Inc. During the two-year period, the company brought in significant funding and received its first FDA device approval. The private company is getting off to a strong start in 2017 with the enrollment of the first patient in the clinical trial for the Sylys surgical sealant. The company said Sylys will serve as an adjunct to standard closure techniques in colorectal and ileorectal anastomosis procedures. "Sylys is a synthetic sealant and when using it, we're not asking doctors to change their technique," Patrick...

By Omar Ford, Staff Writer The U.S. Federal Trade Commission (FTC) has approved Abbott Laboratories' $25 billion acquisition of St. Jude Medical Inc. The deal was green lit after the FTC accepted a proposal for the divestiture of St. Jude's vascular closure device business and Abbott's steerable sheath business to Terumo Corp. Abbott first made a bid to acquire St. Paul, Minn.-based St. Jude earlier this year. (See Medical Device Daily, April 29, 2016.) The proposed deal drew concern from federal antitrust regulators, who said the combined company would control a significant percentage of the vascular closure device market. The...