FDA’s Breakthrough Device Program: It may make a difference

Dr. Malvina Eydelman, Director of the Division of Ophthalmic, and Ear, Nose, and Throat Devices, Office of Device Evaluation FDA’s Breakthrough Devices Program is beginning to show important results for patients since it was established in late 2016 under the 21st Century Cures Act to help patients gain timely access to breakthrough technologies. Consider Second Sight

Medtech stories we missed this week: March 16, 2018

From Intricon expanding its manufacturing space to Arthrex signing a global distribution deal, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Intricon expands medical footprint Intricon announced in a March 13 press release that it has signed a 5-year lease that will secure 30,000 sq. ft of manufacturing

Harmonus receives FDA clearance for ProBx software

Harmonus (Boston) announced that it has received FDA 510(k) clearance for its ProBx software for MRI-guided prostate interventions. The software is a solution to a problem of suboptimal prostate cancer diagnoses and provides doctors and patients with better options to diagnose and treat prostate cancer. ProBx software precisely and efficiently targets and confirms suspicious lesions, unlike

Medtech stories we missed this week: March 2, 2018

From InspireMD’s new distribution deals to Kelynium’s distribution deal with a mystery partner, here are medtech stories we missed this week but thought were still worth mentioning. 1. InspireMD inks distribution deals in Greece, Caribbean InspireMD announced in a March 1 press release that it has signed exclusive distribution agreements with T-Vascular IKE Medical Supplies in

Europe’s new MDR: Is it as scary as you might think?

The European Union’s regulation of medical devices appears to be increasing under the new Medical Device Regulation (MDR) going into effect, while U.S. FDA is easing off. In many ways, the E.U. and the U.S. are going in opposite directions when it comes to medical device regulation, said Michael Drues, a regulatory consultant based outside

Hacking pacemakers is good TV, but is it for real?

Worry less about bad people hacking pacemakers and other cardiac devices. Worry more about them disrupting hospitals’ communications networks. That’s the major message out of the American College of Cardiology’s Electrophysiology Council, which published an article about cardiac devices earlier this month in the Journal of the American College of Cardiology.  The idea that hackers might

Medtronic recalls 48 CRM devices on arcing risk

Medtronic (NYSE:MDT) informed physicians last month of a problem with 48 of its cardiac rhythm management devices that’s prompting a Class I recall of the devices. The recall affects cardiac resynchronization therapy defibrillators and implantable cardioverter defibrillators that were “sent through a manufacturing sequence that introduced the potential for internal arcing during high-voltage charging, leading […]

Medtronic wins FDA nod for smallest drug-eluting stent on U.S. market

Medtronic‘s (NYSE:MDT) 2.0-mm Resolute Onyx drug-eluting stent has won FDA approval and is set to launch in the U.S., making it the smallest device of its kind on the market. The stent is designed to treat patients with coronary artery disease who have small vessels. Interventional cardiologists often face challenges treating this patient group with […]

FDA plans 2018 update for global UDI database

By Stewart Eisenhart, Emergo Group The US Food and Drug Administration will soon implement updates to its Global Unique Device Identification Database, or GUDID, based on feedback and requests from medical device manufacturers. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and

FDA removed 10% of medtech establishments from its registration database: Here’s why

David Lennarz, Registrar Corp. The U.S. FDA has removed 2,546 medical device establishments from its active registration database.  As of Feb. 19, the FDA database contained 24,578 registered establishments, compared to 27,124 registered establishments on Feb. 2. So why did FDA remove the registrations? Establishments are typically removed due to failure to renew their annual

Webinar: How to make sense of safety oversight in clinical research — DSMBs, CECs and Medical Monitors

Thursday, March 22, 2018 2 p.m. Eastern time / 11 a.m. Pacific time     This webinar will provide clinical research professionals with an understanding of safety oversight for clinical studies, including regulatory requirements and best practices. The presentation will include a discussion of the FDA’s Guidance on the Establishment and Operation of Clinical Trial

How to streamline the customer complaint handling process

It can be quite nerve-wracking the first time your medical device company receives a customer complaint. What are your next steps? Is this something serious? Jon Speer, Greenlight Guru At some point, most companies will need to deal with customer complaints. It is a unique process because it’s the only quality process where you interact

Webinar: Where should medical device companies launch products first?

This webinar was presented live on Tuesday, Feb. 27, 2018. Click below to watch on demand.     The regulatory environments are changing, particularly in Europe. In the next few years, we are expecting a complete overhaul of the regulatory standards practiced by the E.U. These events will dramatically change how (and where) medical device

Software is a top cause of medical device recalls: Here’s what you can do

Stericycle Expert Solutions recently conducted a five-year assessment of recall trends, based on its quarterly Recall Index studies. The results show surprising missteps from medical device companies, especially where software is concerned. We asked Chris Harvey, director of recall solutions at Stericycle to answer some questions about the recall trends and offer some advice on

Charting the FDA’s course for 2018-2020

By: Jeff Shuren, M.D., J.D. Since 2012, we at the Center for Devices and Radiological Health have set as our North Star the vision of patients in the U.S. having access to high-quality, safe, and effective medical devices of public health importance first in the world. “First in the world” is not about a competition