Short of votes, Trumpcare bill is withdrawn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

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

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

Medical device firms have little understanding of European MDR, IVDR

By Stewart Eisenhart, Emergo Group Many medical device companies have yet to fully absorb the ramifications of the new European Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) for their compliance efforts, according to Emergo’s 2017 Global Medical Device Industry Outlook. Get the full story here at the Emergo Group’s blog. The opinions expressed

Malaysia plans to ratify ASEAN Medical Device Directive

By Stewart Eisenhart, Emergo Group Malaysia’s medical device market regulatory agency has provided updates on various fronts at a recent seminar attended by Emergo consultants. 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 of MedicalDesignandOutsourcing.com or

David R. Arguin named president of Helix Linear Technologies

Helix Linear Technologies, a player in linear motion and factory automation industries, is pleased to announce that David R. Arguin has earned the promotion to president and member of the company’s executive team, reporting to CEO Christopher Nook. Arguin will have oversight of the strategic direction, expansion, and operation of the company. Arguin has helped

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

New CQI/IRCA-Certified lead auditor training based on ISO 13485 and International MDSAP

NSF International, a global public health and safety organization, is now offering QMS Lead Auditor Training based on both ISO 13485:2016 and international Medical Device Single Audit Plan (MDSAP) requirements. The five-day training program is the first international MDSAP- and ISO-compliant medical device auditing course to be certified by the Chartered Quality Institute (CQI)/International Register of Certificated

QMS compliance: Here are the basics

Rachel Beavins Tracy, Verse Solutions U.S. FDA requires companies to validate any software used in design, manufacture, packaging, labeling, storage, installation and servicing of finished devices. Companies must also use change control to ensure changes to IT systems don’t create unintended risks. But meeting FDA requirements around software validation and change control isn’t always straightforward,