2 paths to success on the medtech fundraising trail

Funding a medical technology company isn’t a simple job: Modern medical devices require cutting-edge innovation, research and design to make it to market. And don’t even get started on regulatory and reimbursement challenges. The recession of the late 2000s, Affordable Care Act and changes to regulatory bodies and reimbursement requirements have changed the game for

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FDA Commissioner asks staff for ‘more forceful steps’ to stem the opioid crisis

By: Scott Gottlieb, M.D. As Commissioner, my highest initial priority is to take immediate steps to reduce the scope of the epidemic of opioid addiction. I believe the Food and Drug Administration continues to have an important role to play in addressing this crisis, particularly when it comes to reducing the number of new cases

Artificial pancreas: These companies are racing to make one

Medical device companies are close to achieving the holy grail of diabetes treatment: a combined glucose sensor, control algorithm and insulin infusion device that effectively acts as an “artificial pancreas.” We explain more in our newest Medical Design & Outsourcing video. (And for a deeper dive, check out our recent roundup of companies in the

Deaths prompt Abbott recall of Thoratec HeartMate II controllers

Brad Perriello, Executive Editor Abbott (NYSE:ABT) is recalling nearly 29,000 controllers for the HeartMate II implantable heart pump made by its Thoratec subsidiary after 26 patients died trying to change out the controllers on their own. The March 29 recall of 28,882 controllers for the HeartMate II left ventricular assist device follows 70 reports of

P&F Machining completes expansion

P&F Machining – a custom machining provider for the medical device and other advanced manufacturing industries – recently celebrated the opening of its new 54,400-square-foot facility in Otsego, Minn. The new building became operational in February, according to P&F Machining President Dan Pawlak. The project cost $6.7 million and brought 40 jobs into Otsego from P&F’s previous

FDA launches medical device cybersecurity workshop

By Stewart Eisenhart, Emergo Group Effectiveness of ongoing efforts to address medical device cybersecurity risks will depend on whether stakeholders can properly balance security, safety and usability issues as well as understand end-user environments, according to speakers at a new US Food and Drug Administration workshop. Get the full story here at the Emergo Group’s

Trump proposes deep cuts to Medicaid, NIH funding

President Donald Trump’s proposed budget would slash Medicaid funding and cut support for major biomedical research programs at the National Institutes of Health and the Centers for Disease Control & Prevention. The budget blueprint drew condemnation from healthcare advocates and lawmakers from both sides of the aisle. Senate majority whip Sen. John Cornyn (R-Texas) reportedly said earlier

Why X-rays in shoe stores were a really bad idea

Vanessa Burrows, FDA historian X-rays have enhanced healthcare in a variety of ways since their discovery in the late 19th century. But like many cutting-edge scientific developments, the technology has also inspired uses of uncertain therapeutic value. That was the case with the shoe-fitting fluoroscope, the subject of the latest episode of FDA’s history video

TransEnterix CEO: Robotic surgery has a big problem

Todd Pope has been working in the surgical robotics space for over a decade. As the CEO of TransEnterix, which has developed Senhance surgical assistance device, Pope believes the surgical robotics market is about to explode. But before it can take off, Pope noted that players have to address a really big problem with robotic

Spectrum Plastics Group: Why the merger took place

The M&A deal creating Spectrum Plastics Group is but the latest in a wave of consolidations taking place among medical device industry outsourcers. Mauricio Arellano, president of Spectrum’s medical division, thinks 2 trends are driving the consolidations: the need of OEMs to provide truly disruptive innovations to meet health providers needs for value-based care, and

FDA and NIH launch new clinical trial protocol writing tool

By Stewart Eisenhart, Emergo Group US regulators at the Food and Drug Administration and the National Institutes of Health (NIH) have published a new writing tool for use in applying for regulatory approval to conduct clinical trials for medical devices and pharmaceuticals. Get the full story here at the Emergo Group’s blog. The opinions expressed

5 officials running healthcare under Trump

President Donald Trump’s critics complain that the president has yet to make hundreds of appointments to midlevel positions. But at least with healthcare, we’re starting to get a clearer picture of who is in charge. Just on May 10, the U.S. Senate confirmed Dr. Scott Gottlieb as FDA commissioner. Here are 5 top officials shaping

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Why adding device identifiers to insurance claims protects patients

The pushback to adopting unique device identifier into claims forms is that the added steps will be burdensome for hospitals. But documenting device identifiers in claims forms is actually “feasible” and “straightforward,” and requires only modest effort, according to a new whitepaper from Boston’s Brigham and Women’s Hospital. Of particular concern was that the device claims

Medtech stories we missed this week: May 19, 2017

From FDA clearances to touting study data, here are some medtech stories we missed this week but thought were still worth mentioning. 1. XpandOrtho wins FDA 510(k) clearance XpandOrtho announced in a May 17 press release that it has received FDA 510(k) clearance for its electronic soft tissue balancing instrument for total knee replacement surgery. The

FDA proposes Conformity Assessment pilot

By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have begun seeking stakeholder feedback for a proposed system to better evaluate registrants’ compliance with voluntary consensus standards. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and