This year’s med tech conference was a lot like previous years’ events, but the heat of the moment is always telling, isn’t it? Following are a few developments that were part of the conference by design or by chance, but the task of sorting out which will and will not leave a mark, as it were, is no mean feat. Lab test fee or a test of labs’ patience? The draft clinical lab fee schedule blew up just in time for the conference with a publication date of Sept. 22, which...

Technology seems to leap ahead at an astounding pace and is disruptive for many businesses, but is achingly slow for patients who await disease detection and treatments. A recent TED Radio Hour, “Fighting Cancer,” included speakers who addressed their approaches to speeding the move toward more precise and faster-acting cancer diagnostics and targeted therapies. James Bradner of Dana Farber Cancer Institute, and president of Novartis Institutes for Biomedical Research, was part of a research team which shared the molecule they discovered to treat a rare form of cancer publicly. The normal steps after research of protecting the information and developing...

As the summer doldrums draw mercifully to a close, we can look back over a more or less expansive period of time to see where we’ve been in some hope of divining where things might be headed. Or maybe it’s just fun to revisit the past. In any event, following are a couple of developments of interest in the world of med tech. Device warning letters tank In case you were wondering whether industry pressure on the FDA regarding device inspections was having any effect, the jury is more or less back and...

Rock and roll radio stations used to tout their two-for-Tuesday and three-for-Thursday lineups, but we at BioWorld MedTech think every day is good for a threefer. Below are three stories of recent vintage to grace the pages of BWT, at least one of which suggests that the FDA budget may be caught up in the next presidential election. All-user fee FDA not a reality … yet The Senate has passed legislation for the latest FDA user fee agreements, and President Trump signed the deal last week despite the President’s expressed preference for an...

My first real exposure to what's commonly called augmented reality was about a year ago when one of my former colleagues introduced me to Pokemon Go. I remember her telling me that you could actually hold up your smartphone or tablet and see actual Pokemon along the street. Now fast forward by a year, and most of the hype surrounding the game has waned off. However there is still tremendous enthusiasm with augmented reality. In fact reality altering technology isn't just regulated to Pokemon and the video gaming industry, it has invaded health care and looks to be more...

When my now middle-aged dog was a puppy, I looked into taking him to basic obedience classes. At one of these sessions, a group of newbie pet owners gathered in a room tucked into the back of a pet store. Each came armed with a pocketful of treats or a clicker, hopeful to see results with their pet. As the class went on, some pets obliged their owner’s coaxing to sit or lie down, while others angled for treats. It quickly became apparent that much of the training that was necessary to make a well-behaved dog was actually on the...

Louis Armstrong's Summer Song evokes an inviting and mellow season, but a leisurely pace can be a pain in the neck for a med tech writer. The FDA's device center might not be pumping out guidances of late, but the courts are always in business, providing grist for the mill even when federal government agencies seem to have fallen prey to the summertime blues. Forward to the past at CAFC Michael J. Fox had to go back to the future in a movie thusly titled, but...

Royal Phillips NV is set to acquire Spectranetics Corp. for €1.9 billion ($2.2 billion). The proposed acquisition is the latest in a string of efforts the Amsterdam, the Netherlands-based company has made to strengthen its position in health care. The deal is set to close in 3Q17. Upon news of the proposed deal, shares of the Colorado Springs based-company (NASDAQ:SPNC) were up on Wednesday by about 26.15 percent and trading at $38.35. Philips said the acquisition will further expand and strengthen its image-guided therapy business group, which was bolstered significantly by the company agreeing to...

Diabetes data management company Glooko closed a series C funding round with $35 million in financing, led by Georgian Partners. The Mountain View, Calif., company plans to use the funding to continue growth, including internationally, and invest in analytics. Georgian Partners, of Toronto, invests in machine learning and applied analytics. Additional investors new to this round are the Mayo Clinic and Insulet Corp. Returning investors include Canaan Partners, Social Capital, Medtronic and Samsung Next. Expansion, commercialization with funding Glooko plans to expand its commercialization efforts in Germany, France, the U.K., Asia and the Middle East....

The U.S. Food and Drug Administration has approved the Oncomine Dx Target Test from Thermo Fisher Scientific Inc. It is the first test of its kind to screen tumor samples for biomarkers associated with multiple cancer therapies, in this case for non-small-cell lung cancer (NSCLC). It is expected to enable more rapid evaluation of treatment options for these patients, in days rather than over several weeks. The test was developed in collaboration with Novartis AG and Pfizer Inc.; some of the first labs to offer it will include Laboratory Corporation of America's Diagnostics and Covance...