The top medtech stories of early 2017

The new Trump administration and Republican Congress – and all the accompanying change and uncertainty –is the major story for the medical device industry. But there are many other medtech stories worth noting from the first quarter of 2017. There was an FDA warning over Abbott’s Absorb bioresorbable stent, a continued spate of M&A deals, a

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Trump proposes higher FDA fees for drug, medical device FDA registrants

By Stewart Eisenhart, Emergo Group US Food and Drug Administration user fee increases in the Trump Administration’s proposed 2018 federal budget would disproportionately impact smaller medical device companies, as these firms make up the majority of the US medical device industry. Get the full story here at the Emergo Group’s blog. The opinions expressed in

MedLumics secures 34.4M Euros in Series B funding

MedLumics, a cardiac device company specializing in optically guided minimally invasive instruments, announced that it has raised 34.4M Euros in financing that will be used to help advance the product and clinical development of the company’s AblaView catheter, intended for the treatment of atrial fibrillation (AF) and other arrhythmias. This financing is the largest in

Trump budget would double FDA user fees

Brad Perriello, Executive Editor The Trump administration’s proposed budget, released today, would double the user fees medical device companies pay to have the FDA review the safety and efficacy of their products. The budget proposal would set user fees at $2 billion for 2018, about $1 billion more than the fee schedule for this year (annualized to correspond

Medtech stocks slump on 18% NIH cut in Trump budget plan

Brad Perriello, Executive Editor The Trump budget plan to slash more than 18% from the budget for the National Institutes of Health sent medical device stocks down today on Wall Street as investors reacted to the proposal. The budget proposal, released today, would cut the NIH budget by $5.8 billion, to $25.9 billion – an 18.3% cut.

Medtech stores we missed this week: March 10, 2017

The FDA and Health Canada cleared a couple medical devices while other companies touted their device studies. Here are medtech stories we missed this week but were still worth mentioning. 1. FDA clears Medela’s neonatal enteral feeding device Medela has received 510(k) clearance from the FDA to market its ENFit Low Dose Tip eternal syringes,

Avinger tumbles on Q4 revenue miss

Shares in Avinger (NSDQ:AVGR) dropped today after the medical device maker missed expectations on Wall Street with its 4th quarter results. The Redwood City, Calif.-based company posted losses of -$13.5 million, or -58¢ per share, on sales of $4.7 million for the 3 months ended Dec. 31, for bottom-line loss of -0.3% on sales growth of 64% compared

Analysis: 5 ways Trump is making things uncertain for medtech

Want a word to sum up 2017? Try “uncertainty.” Chris Newmarker, Managing Editor Wall Street investors remain on a sugar high from the new Trump administration and Republican Congress. The Dow Jones Industrial Average is up hundreds of points since President Donald Trump’s promise to a joint session of Congress on Tuesday that he wanted to

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Contact lens maker VTI plans IPO Down Under

Visioneering Technologies this week priced its A$33.3 million initial public offering on the Australian Securities Exchange. The U.S.-based contact lens maker said it’s offering 79.4 million shares of its Class A common stock priced at ¢42 apiece. The company plans to use the net proceeds from the IPO to provide capital as VTI broadens the U.S.

Integer Holdings shares dip after Q4 earnings report

Shares in Integer Holdings (NYSE:ITGR) dropped today after the medical device maker released 4th quarter and full year 2016 earnings that beat earnings per share expectations but missed on revenue.  The Frisco, Texas-based company—a major U.S. medical device contract manufacturer—posted profits of $7.9 million, or 25¢ per share, on sales of $359.6 million for the 3 months ended

Medical device companies report sales increases in 2016

By Stewart Eisenhart, Emergo Group One third of all medical device companies participating in a recent Emergo industry survey reported sales increases of 10% or more for 2016. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those

Is health IT going to drink medtech’s funding milkshake?

Healthcare companies in the U.S. midwest last year brought in $1.7 billion in investments—an amount that came within $60 million of the all-time record set in 2014, according to the BioEnterprise Midwest Healthcare Growth Capital Report. Medical device companies took in the largest chunk of money, raising $696 million, or 40.3% of the total. But

Medtech stories we missed: Feb. 17, 2017

Several companies released diabetes study results this week, while companies like BioTime closed on their public offerings and Pixium implanted its first bionic eye. Here are medtech stories we missed this week, but were still worth mentioning. 1. Insulet touts glucose control study Insulet Corp. announced the results from its first feasibility study of its Omnipod Horizon hybrid

Why medtech companies should implement regionalized sales models

Having more flexibility in how sales roles are deployed and allowing more customization in regions represents the next frontier of productivity. Pete Masloski, ZS In today’s dynamic healthcare environment, IDN consolidation and centralized medical device purchasing are creating significant pricing pressure on the medical device industry. In fact, on average, prices for costly medical devices

S&P: Medtech outlook stable, even after downgrades

The outlook for investment-grade medical device companies remains stable even after a 3-year streak of 9 consecutive downgrades, according to a new report from S&P. The downgrade of investment-grade medical device companies was mostly caused by debt-financed mergers and acquisitions, according to S&P. Factors like changes in operating performance trends and financial policy also contributed