This is not a test: RMAT designation goes live

By: Peter Marks, M.D., Ph.D. The field of regenerative medicine encompasses a wide scope of innovative products including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and certain combination products using such therapies. Examples include genetically-modified cellular therapies, such as chimeric antigen receptor T-cells (CAR-T cells) and human tissues grown on scaffolds

Medtech stories we missed this week: March 24, 2017

From companies receiving CE marking to other companies adjusting their distribution deals, here are medtech stories we missed this week but thought were still worth mentioning. 1. Viveve Medical closes public offering Viveve Medical announced that it closed its underwritten public offering of 8,625,00 shares of its common stock, according to a March 22 news release.

Short of votes, Trumpcare bill is withdrawn

Republican leaders in the US House of Representatives today withdrew the GOP-backed Trumpcare bill, which aimed to begin dismantling and replacing Obamacare, due to a shortage of votes. A vote on the measure was planned after Trump cut off negotiations with Republicans who had balked at the plan. Trump had issued an ultimatum to vote

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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Little or no audit preparation common device QMS problem

By Stewart Eisenhart, Emergo Group In the second in a series of blog posts examining common problems medical device firms deal with related to quality management system audits, Emergo discusses how lack of proper internal audit preparation leads to last-minute scrambles and business headaches. Get the full story here at the Emergo Group’s blog. The

House delays vote on Trumpcare bill

The U.S. House of Representatives today indefinitely delayed its vote on the Trumpcare legislation, which looks to begin dismantling Obamacare and replacing it with a GOP-supported framework. The Trump administration and the GOP had hoped the day would signal a significant turn for conservatives, with Trump and House Republican leaders planning the vote on the

How Phononic is upping the game on hospital refrigeration

Solid-state heating and cooling technology company Phononic recently got its Evolve refrigerators into the new North Carolina Heart & Vascular Hospital at UNC Rex in Raleigh, N.C. UNC Rex Healthcare is using a combination of 1.8 and 5.5 CuFt Evolve refrigerators in its pharmacy, patient support areas and medicine rooms in conjunction with medication management systems,

This Trumpf laser could solve your UDI compliance problems

Trumpf is touting a new laser and software module that enables UDI marking from a single source. Medical device makers can create corrosion-resistant marks on highly reflective materials using ultra-short pulsed lasers. By combining a marking laser with a UDI software module, Trumpf offers both components from a single source. This helps manufacturers to comply with

The stem cell ‘skin gun’ that’s aiming to disrupt wound care

RenovaCare’s SkinGun uses a patient’s own stem cells to heal their wounds faster and more efficiently than a traditional skin graft. Pennsylvania state police officer Matthew Uram suffered severe second-degree burns to his face, right arm and leg after a friend’s bonfire got out of control. Uram was facing months of painful skin grafts, the

The stem cell therapy that could reverse hearing loss

Frequency Therapeutics is betting that it can change the lives of millions of Americans with hearing loss through a cell therapy that triggers the body’s natural ability to heal itself. Researchers have used cells in regenerative medicine for decades – in 1931, the father of cell therapy, Paul Niehans, treated a patient with material from

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

David Timmersman appointed president of Vitaldyne

David Timmersman has been appointed president of Vitaldyne, a contract manufacturer specializing in the manufacture, assembly and packaging of medical devices and components. Timmersman assumes the position held by Mariellyn Kuske, a founder of the company who will be retiring once the transition to new leadership is complete. Mariellyn Kuske, along with her husband Mike, began Vitaldyne

6 visual impairment breakthroughs you need to know

About 285 million people have some form of visual impairment in the world, according to the World Health Organization. Of that number, 39 million are considered blind, and 246 million have low vision. Three-fifths of all vision impairment can be prevented or cured. Uncorrected refractive errors are one of the main causes of vision impairment in

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How to make ultrasound zap tumors in a moving organ

Researchers led by the Fraunhofer Institute for Medical Image Computing think they’ve overcome the challenges standing in the way of using ultrasound to kill cancer tumors in organs that move with breathing. Until now, health practitioners have mostly limited ultrasound to treating prostate cancer, bone metastases and uterine myoma, according to the Fraunhofer Institute (Bremen, Germany). Organs

Do patient advocacy organizations have a conflict of interest?

At least 83% of U.S. patient advocacy organizations receive financial support from medical device, drug and biotechnology companies, according to new research out of the University of Pennsylvania’s Department of Medical Ethics and Health Policy. The Penn research team – which included Matthew McCoy, Harald Schmidt and Ezekiel Emanuel – examined websites and annual reports for 104 organizations