By Stewart Eisenhart, Emergo Group Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has increased registration, inspection and related regulatory fees for medical device market applicants. 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 MassDevice.com or […]
Irish medtech startup wins $3M in grants
Galway, Ireland-based startup Signum Surgical said today that it has landed more than $3 million in grants to help fund its efforts to gain U.S. and European regulatory clearance of a device intended to treat a condition that can cause fecal incontinence. The grants include $2.04 million from the European Union Horizon 2020 SME Instrument […]
Final defendant sentenced in insider trading case
Federal prosecutors have wrapped up an insider trading case based on alleged tips from a Bank of America consultant on pending corporate transactions, including Abbott‘s (NYSE:ABT) $25 billion acquisition of St. Jude Medical. Rodolfo Sablon, 39, of Miami, Fla., was sentenced Friday to six months in prison for his role in the insider trading scheme based […]
FDA recommendations from the annual Human Factors and Ergonomics Society symposium
By Erin Davis and Allison Strochlic, Emergo Group Manufacturers, consultants, researchers, and regulators all descended upon Chicago this week for the annual Human Factors and Ergonomics Society Health Care Symposium. After taking in dozens of oral presentations and hundreds of posters, attendees often walk away from the event feeling invigorated that there are so many […]
Abiomed touts new Impella study results
New data on Abiomed (NSDQ:ABMD) Impella heart pumps show a 34% increase in survival among nearly 5,000 patients treated with the company’s devices intended to treat cardiogenic shock when combined with best practices, according to a company study. The study of patients treated at 763 U.S. sites between April 1, 2018 and March 28, 2019 showed median […]
How medical device human factors researchers can ensure GDPR compliance
By Stewart Eisenhart, Emergo Group Following Emergo by UL’s recent webinar on the European Union’s General Data Protection Regulation (GDPR) and human factors studies for medical devices, we examine key GDPR compliance issues human factors researchers must address to avoid steep penalties. The webinar was presented by Allison Strochlic and Alexandria Trombley, Research Director and […]
Orthofix Medical touts data from artificial disc study
A study of patients implanted with Orthofix Medical’s (NSDQ:OFIX) M6-C artificial cervical disc showed a significant improvement in neck and arm pain, function and quality of life scores, the company said today. Patients in the investigational device exemption (IDE) study also used less pain and opioid medication when compared with anterior cervical discectomy and fusion […]
Loop Medical lands $3.2M grant for blood collection device
Loop Medical said today that it has received a $3.2 million grant from the Bill & Melinda Gates Foundation to support pre-production and clinical trials required for the global registration of its blood collection device. The foundation had previously given the company a $400,000 grant. Based at the Swiss Institute of Technology (EPFL) in Lausanne, […]
Cigna lowers insulin price to $25 per month
Under pressure from patients and the FDA, Cigna (NYSE:CI) and Express Scripts said today that they will lower the price of insulin to $25 per month for some patients. Three firms — Eli Lilly, Novo Nordisk and Sanofi — control 90% of the global insulin market and produce all the insulin used in the U.S. […]
FDA wants public input on AI-enabled device regulation
The FDA today floated some ideas on how it might regulate medical devices armed with artificial intelligence — also known as software-as-a-medical-device (SaMD) — whose algorithms can change based on machine learning (ML) and possibly affect people in ways for which they were not approved or cleared. It is also asking for the public’s feedback. To date, […]
What a new FDA commissioner could mean for clinical research
With the resignation of FDA Commissioner Scott Gottlieb taking effect this month, many clinical research professionals are wondering how this could impact their drug and device trials. During his tenure of just under two years, Dr. Gottlieb introduced a number of initiatives, including one aimed at aggressively regulating teenage vaping, reducing nicotine in cigarettes to non-addictive levels […]
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