FDA launches medical device innovation challenge to combat opioid crisis

The U.S. FDA today announced that it has launched an innovation challenge to encourage the development of medical devices to help reduce the country’s opioid abuse crisis. The hope is that the challenge will result in new medtech including digital health technologies and diagnostic tests to help detect, treat and prevent addiction, according to FDA. Go

This robotic system can automatically adjust ultrasound equipment

Neural Analytics today announced that it has won FDA clearance for a robotic system that can automatically adjust the company’s ultrasound equipment to monitor blood flow through the brain from outside the body. NeuralBot was designed to work with the company’s previously approved Lucid M1 transcranial Doppler ultrasound system, a portable all-in-one ultrasound system designed

Pursuit Vascular wins expanded indication for antimicrobial device

Pursuit Vascular (Maple Grove, Minn.) today announced that it has won FDA clearance for a broader indication of its ClearGuard HD antimicrobial caps. The new indication for the caps — used as an antimicrobial device for catheter-based dialysis patients — includes reduction in the incidence of central-line associated bloodstream infection in hemodialysis patients with central

FDA takes cautious approach to new regulations for OEM and third-party device servicers

Joel Domanowski, Emergo Group The U.S. FDA has cited insufficient evidence regarding public health concerns to warrant new regulatory requirements for original equipment manufacturers (OEM) and third-party servicers of medical devices, but will take less formal steps to ensure safety and effectiveness of these entities’ products and services. Get the full story here at the

Medtech stories we missed this week: May 25, 2018

From Mauna Kea receiving FDA clearance to Medacta getting clearance for its pedicle screw placement guide, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Mauna Kea wins FDA nod for neurosurgery indication Mauna Kea announced in a May 24 press releasethat it has received FDA 510(k) clearance for

3 ways to streamline global medical device registrations

Global medical device registrations can be time-consuming and costly for organizations. Here are some ways to make the process better. Alex Butler, MasterControl Obtaining clearance or approval for a medical device in the U.S. is cause for celebration. Obtaining clearance or approval for a medical device in multiple foreign countries is cause for jubilation. On

Will FDA turn to neuroscience-based human factors research?

There is a new wind blowing in medical technology — one that many believe is overdue: an overhaul of human factors. At the recent Patient Safety Initiative, Charles Murphy, Chief Patient Safety Officer at the Inova Heart and Vascular Institute, called out human factors as one of the key factors he believed needed to be

FDA is asking for more information on application forms: Here’s why that’s good for innovation and improving health

By: Dr. Christopher Leptak To be most effective, electronic health records (EHRs) use a systematized and standardized nomenclature for the hundreds of thousands of clinical terms that characterize patient care. This helps to ensure consistency from EHR to EHR and allows these records to be usable from healthcare entity to health care entity, a concept

Medtech stories we missed this week: May 11, 2018

From ReShape submitting an approval application to Health Canada to Conavi receiving FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. ReShape submits for Health Canada approval of ReShape balloon ReShape announced in a May 10 press releasethat it has submitted an application to the Medical Devices Bureau of

FDA clarifies multiple-function medical device oversight policy

Stewart Eisenhart, Emergo Group New guidance from the U.S. Food and Drug Administration addresses premarket authorization requirements for multiple-function products with at least one function that qualifies as a medical device. 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

Medical device recalls significantly increase during Q1

The medical device and pharmaceutical industries saw a significant spike in product recalls during the first quarter of 2018, according to the U.S. Recall Index released by Stericycle Expert Solutions. There was a 126% increase in medical device recalls in Q1 — the most in a quarter since 2005. Software problems made up about 22.7%

7 QMS tools to demonstrate compliance with 21 CFR Part 820 for medical devices

Rachel Beavins Tracy, EtQ 21 CFR Part 820 contains a huge number of “shall” requirements for medical device manufacturers. While it may seem impossible to meet so many requirements, a well-constructed Quality Management System (QMS) provides an excellent starting point and framework for compliance. So, how can manufacturers use the QMS to demonstrate compliance with

Is FDA’s easing of medical device malfunctioning reporting a good thing?

The news came out in 2016 that medical device companies were late filing more than 300,000 adverse events reports to U.S. FDA. “I think that’s simply embarrassing as an industry,” regulatory consultant Mike Drues said during his latest podcast with Medical Design & Outsourcing. FDA’s solution has partly been to propose an easing of the reporting requirements.

Medtech stories we missed this week: April 27, 2018

From DuPuy Synthes’s spinal implant launch to Lumendi’s FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. DePuy Synthes launches spinal implants DePuy Synthes announced in an April 26 press release that it has launched its Proti 360º integrated titanium family of interbody devices that are designed

FDA OKs Opus breast implant line from Sientra, with Lubrizol manufacturing

The FDA this week granted a pre-market approval supplement to Sientra (NSDQ:SIEN) for its Opus line of silicone breast implants. The implants are made in Wisconsin by Lubrizol LifeSciences subsidiary Vesta, which inked a contract manufacturing deal with Sientra back in August 2016. Sales of Sientra’s silicone breast implants ground to a halt in the autumn of 2015, when […]