By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration has initiated a new pilot program for expanded eligibility in the agency’s Special 510(k) pathway, potentially easing market compliance requirements for more manufacturers whose devices have undergone modifications. Get the full story here at the Emergo Group’s blog. The opinions […]
What “no-deal” Brexit means for medical devices
By Ronald Boumans, Emergo Group The UK will leave the European Union on March 29, 2019 – Brexit day. On that day the EU will lose an important Member State, and the UK will no longer have direct access to the 27 remaining Member States. Therefore both the EU and the UK want to work […]
New eye health companies gain funders’ focus
Startups pioneering less-invasive technologies to treat common eye diseases are changing the outlook for both patients and the industry. A new study by CB Insights revealed that investors have been pouring money into smaller companies in 2017 and 2018, with some FDA approvals to begin marketing their technologies and treatments. These firms are eyeing conditions […]
Where medtech is putting its money this November
Republicans reaped nearly $3.3 million in federal political contributions from the medtech industry in the 2017-18 election cycle, compared with $1.85 million for Democrats, according to data collected by the Center for Responsive Politics, a nonprofit campaign finance watchdog group. Medtech has “historically been a little more Republican than the average industry,” said Andrew Mayersohn, committees researcher […]
How to ensure compliance before your medical device trial begins
By Sandra Maddock, IMARC The only way to gain the FDA approval you need to bring your medical device to market is to ensure compliance at every stage in the clinical trial lifecycle. That starts long before you sign up your first subject. The planning stage is crucial because it sets expectations for how your […]
India regulators update medical device and IVD oversight programs
By Stewart Eisenhart, Emergo Group Indian regulators have recently announced several updates regarding their medical device and IVD oversight programs. 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 its employees.
Neovasc touts Tiara TMVR success rate in study
A small study of the Neovasc (NSDQ:NVCN) Tiara transcatheter mitral valve replacement (TMVR) in high-risk patients revealed a 100% procedural success rate and immediate elimination of mitral regurgitation. Published in Circulation: Cardiovascular Interventions, the study also showed no death, myocardial infarction, stroke, major bleeding, or access site complications at 30 days. The twelve patients in the study […]
BD’s Bard updates on higher restenosis rate for LifeStream covered iliac stent
C.R. Bard (NYSE:BCR) has notified buyers of its LifeStream covered iliac stent of a higher-than-anticipated restenosis rate among patients. The field notice issued by Bard, parent company BD and Irish catheter-maker ClearStream Technologies said the restenosis rate of 0.04% exceeds the acceptable failure rate of 0.01%. An unspecified number of restenosis complaints was reported following implantation of […]
U.S. regulators to overhaul third-party 510(k) review program
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has set a goal of obviating the need to re-review 85% or more of 510(k) applications that have undergone third-party review by the agency’s 2021 fiscal year. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
Micro Interventional Devices begins study of tech for heart valve repair
The first patient in the transcatheter arm of a European study has been treated with Micro Interventional Devices’ MIA technology for tricuspid and mitral repair, the company said. A team at Vilnius University Hospital Santariskiu Clinic (Vilnius, Lithuania) used the 12F MIA (minimally invasive annuloplasty) delivery catheter and PolyCor anchors to reduce tricuspid annular dimensions and […]
NeoTract says real-world prostate study beats clinical trial results
A study evaluating NeoTract’s UroLift treatment for men with enlarged prostate glands showed a 62% improvement in lower urinary tract symptoms, the company said today. The real-world study enrolled 100 men with benign prostatic hyperplasia (BPH) at a single center. Peak flow rate improved 140% and the post-void residual volume (PVR) decreased by 71 ml, with […]
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