Who’s afraid of the big, bad PMAs?

PMAs at FDA are often a scary process for medical devices developers. But that doesn’t have to be the case, according to Michael Drues, a regulatory consultant based outside Boston who has worked with both medical device companies and FDA. There are many myths around premarket approval, such as the idea that PMAs always require

Medtech stories we missed this week: July 6, 2018

From Zetta getting FDA clearance to Prescient Medical receiving CE Mark approval, here are five medtech stories we missed this week but thought were still worth mentioning. 1. Zetta wins FDA clearance for Zoom MRI software Zetta announced in a June 25 press release that its MRI software has received FDA 510(k) clearance. The software, known as

Greenlight Guru and FDA to present Case for Quality webinar series

Greenlight Guru (Indianapolis) announced that it is presenting a joint-webinar series with the FDA to provide awareness of the FDA’s Case for Quality program. The Case for Quality programs allows the FDA to work with stakeholders in the healthcare industry, such as manufacturers, healthcare providers, patients, payers and investors. The program helps move the focus from

Medtech stories we missed this week: June 22, 2018

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

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

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

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

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

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

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

This webinar was presented live on Wednesday, July 11, 2018. Click below to watch on demand.   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

Medtech stories we missed this week: June 8, 2018

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

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

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

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