From Accuray’s India approval to Masimo and PositiveID launching a Bluetooth-enabled thermometer, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. India approves Accuray’s Radixact X9 radiation therapy device Accuray announced in a June 21 press release that it has received an Atomic Energy Regulatory Board Type Approval in India
White House proposes 30% cut to FDA headcount, reorganization
June 22, 2018 By Leave a Comment
The Trump administration this week submitted a proposal that would cut the budget and staff at the FDA, as well as reorganizing the agency to remove food regulation from its purview, according to a new Endpoints News report. The proposal would cut $1.3 billion in resources from the agency and 5,000 members of its staff […]
Bay Labs wins FDA clearance for AI-based echocardiogram analysis
June 19, 2018 By Leave a Comment
Bay Labs has received 510(k) clearance from U.S. FDA for use of its EchoMD AutoEF software product to provide fully automated clip selection and calculation of left ventricular ejection fraction (EF), the San Francisco–based company said today. The EF is the percentage of blood leaving a heart each time it contracts. Bay Labs in its news release
DreaMed Diabetes wins FDA authorization to market insulin therapy management platform
June 18, 2018 By Leave a Comment
DreaMed Diabetes said today that U.S. FDA has granted a de novo request for DreaMed Advisor Pro, its AI-based diabetes treatment decision support software. The news comes about four months after the Petah Tikva, Israel–based company won CE Mark clearance for the decision-support platform, which is meant to help healthcare professionals manage insulin therapy for people with Type
Medtech stories we missed this week: June 15, 2018
June 15, 2018 By Leave a Comment
From Cytosorbents opening a new U.S. manufacturing facility to DyAnsys received FDA clearance for a wearable to treat opioid withdrawals, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Cytosorbents opens new U.S. manufacturing facility CytoSorbents announced in a June 12 press release that it has opened a new
Here’s how FDA officials think you can legally promote off-label device, drug uses
June 13, 2018 By 2 Comments
The FDA has issued final guidance clarifying what it considers permissible off-label information for device makers and drug companies to convey to potential customers. A pair of guidance documents outlines how medtech and pharmaceutical companies can explain to payors and hospitals how their products can affect outcomes and potentially save money, beyond what the products’ indication with the
Medtronic warns on external pacemaker issues
June 13, 2018 By Leave a Comment
Medtronic (NYSE:MDT) has released an urgent field safety notice warning of issues with a subset of its model 53401 single chamber external pacemakers in which the device may experience an unexpected power on reset. The Fridley, Minn.-based company said that the issue is due to an initial version of the firmware for the device which allowed […]
Webinar: Here’s how 2018 is shaping up for medtech
June 11, 2018 By Leave a Comment
Wednesday, July 11, 2018 2 p.m. Eastern time/ 11 a.m. Pacific time There has been a lot of news for the medical device industry and medtech during the first half of 2018, from the threat of tariffs to layoffs at IBM Watson Health. MassDevice and Medical Design & Outsourcing associate editors Fink Densford and Sarah
Medtech stories we missed this week: June 8, 2018
June 8, 2018 By Leave a Comment
From Royal Philips receiving FDA clearance to NeuroPace launching its epilepsy treatment device, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Philips’s Ingenia Elition 3.0T MR scanner Royal Philips announced in a June 5 press release that it has received FDA 510(k) clearance for its Ingenia
FDA warns of 5 new deaths from liquid-filled intragastric balloons
June 4, 2018 By Leave a Comment
The FDA today released a notice warning of five new patient deaths related to two liquid-filled intragastric balloon systems used to treat obesity, produced by Apollo Endosurgery (NSDQ:APEN) and ReShape Lifesciences (NSDQ:RSLS). The additional deaths bring the total number of deaths worldwide from the Orbera intragastric balloon and ReShape integrated dual balloon system up to 12 since […]
Power morcellation: Questions linger for controversial tech
June 1, 2018 By 4 Comments
Dr. Amy Reed’s tragic case brought to light the cancer risks posed by power morcellation. Her death hasn’t stopped lingering questions about the technology. Power morcellators were used for 20 years to laparoscopically remove fibroids, benign tumors of the uterus, raising not a single adverse event report with the FDA. That all changed in 2013,
FDA plans fast-track development and marketing program for medical devices that treat opioid addiction
June 1, 2018 By Leave a Comment
Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have initiated a new campaign to support development and commercialization of novel devices aimed at pain treatment and opioid addiction. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only
FDA launches medical device innovation challenge to combat opioid crisis
May 30, 2018 By Leave a Comment
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
May 30, 2018 By Leave a Comment
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
May 30, 2018 By Leave a Comment
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
