“E-cigarettes” are a class of consumer devices designed to deliver drugs, primarily nicotine or marijuana oils, to the lung by vaporization. Regulation of the devices in the United States is relatively minimal, and research on both epidemiology and potential toxicity has focused on nicotine devices. In 2019, an outbreak of an acute respiratory illness in the United States was traced back to the contamination of e-cigarette fluids with vitamin E acetate, which had been used to disguise the dilution of marijuana oils. The outbreak, termed “e-cigarette or vaping associated lung injury” by the U.S. Centers for Disease Control, was characterized by pulmonary infiltrates and hypoxia, which usually required hospitalization and, often, admission to ICUs. The syndrome sickened >2,600 people, mostly young men, and killed >50 people before it began to abate 6 months later. No current regulations exist to prevent a similar event with the same or different chemical contaminants. Absent such regulation, respiratory practitioners should be prepared to evaluate, identify, and treat future cases of acute lung toxicity from e-cigarettes.

The company could be preparing to release a new iMac, a new pair of AirPods, and an updated Apple TV 4K.

Miniature devices that could be developed into safe, high-resolution imaging technology, with uses such as helping doctors identify potentially deadly cancers and treat them early, have been created.

In a small trial, implanting electrodes into the brain helped women with severe anorexia gain weight and feel less anxious and depressed

Surface Book 3 gets more RAM, Surface Go 2 gets a bigger display, and more.

Innovations are taking place around the country as doctors and entrepreneurs turn their ingenuity to solving the country's ventilator shortage.

Two new pairs of headphones join the laptops and tablets in today's announcement.

By: Suzan Onel FDA issued a Press Release on March 28, 2020, reiterating what we all have seen in the news, there is a severe shortage of personal protective equipment (PPE) in health care facilities across the country.  In response to the shortages, FDA has issued Emergency Use Authorizations (EUAs) for respirators, ventilators, ventilator tubing

The post Shortage of PPE and other Devices During COVID-19 Pandemic – Is 3D Printing the Answer? appeared first on Kleinfeld Kaplan & Becker LLP.

The UK government has announced it will be ending support for four devices in the Ventilator Challenge.

Japanese electronics manufacturer Epson Imaging Devices Corporation (Epson) agreed to plead guilty and pay a $26 million criminal fine for its role in a conspiracy to fix prices in the sale of Thin Film Transistor-Liquid Crystal Display panels (TFT-LCD) sold to Motorola Inc.

“The Department of Justice will be vigilant in pursuing cases against medical device companies that break the law and defraud taxpayers,” said Tony West, Assistant Attorney General for the Justice Department’s Civil Division.

The United States has filed a complaint against Boston Scientific Corp. and related Guidant entities under the False Claims Act for conduct relating to certain of its cardiac devices.

St. Jude Medical Inc. has agreed to pay the United States $3.65 million to resolve civil allegations under the False Claims Act that the company inflated the cost of replacement pacemakers and defibrillators purchased by the Departments of Defense and Veterans Affairs, the Justice Department announced today. St. Paul, Minn.-based St. Jude Medical develops, manufactures and distributes cardiovascular and implantable neurostimulation medical devices.

The Justice Department announced today that it and the National Federation of the Blind have reached a settlement with the Sacramento Public Library Authority in Sacramento, Calif., to remedy alleged violations of the Americans with Disabilities Act (ADA). The agreement resolves allegations that the library violated the ADA by using inaccessible Barnes & Noble NOOK electronic reader devices in a patron lending program.

In a settlement with the United States on behalf of the U.S. Environmental Protection Agency, automotive electronics manufacturer Edge Products LLC (Edge) has agreed to pay a $500,000 civil penalty for manufacturing and selling electronic devices that allowed owners of model year 2007 and later diesel pickup trucks to remove emission controls from their vehicles.

Boston Scientific Corp. and its subsidiaries, Guidant LLC, Guidant Sales LLC and Cardiac Pacemakers Inc. (Guidant), have agreed to pay $30 million to settle allegations that, between 2002 and 2005, Guidant knowingly sold defective heart devices to health care facilities that in turn implanted the devices into Medicare patients.

Omni Surgical L.P., doing business as Spine 360, a manufacturer of devices used in spinal surgery, and Dr. Jamie Gottlieb, an Indiana spinal surgeon, have agreed to pay $2.6 million to the United States to settle allegations that Spine 360 paid illegal kickbacks to Gottlieb to induce him to use the company’s products.

By Alice Li, MD, MSc, RAC (CAN), Regulatory Scientist, Cato Research FDA issued “The Abbreviated 510(k) Program – Guidance for Industry and Food and Drug Administration Staff” on 13 September 2019. The content of this guidance supersedes the content from 1998 guidance “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket …

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The coronavirus pandemic has infected more than 2.5 million people worldwide, with the United States accounting for nearly 1 million of those cases.

From : Communities>>Regulatory Open Forum
Thank you Dinar! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------

From : Communities>>Regulatory Open Forum
Thank you Richard! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------

There is going to be a time in the not too distant future, when the fuller picture of the healthcare impacts of COVID-19 come into sharper focus. When that happens, it is not likely to be pretty. In large part, … Continue reading →

After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies the applicable rules when importing medical devices into Europe, which is the world’s second-largest device market. Rules relate, for...… Continue Reading

Yokogawa Electric Corporation (TOKYO: 6841) and MetaMoJi Corporation announce that they have jointly developed SensPlus Note, a low cost and easy to implement solution for the digitization of plant data on mobile devices. SensPlus Note, a solution in Yokogawa's OpreX Operation and Maintenance Improvement family, improves the efficiency and quality of maintenance work and the precision of post-maintenance analyses by enabling data from plant field work to be used more efficiently. This solution will be released in all markets worldwide on January 31.

Discover how to test your websites and web apps in the browser across desktops and mobile devices using Adobe Edge Inspect.

And now, in the 'Give me a break' category, the folks behind this garbage can scanner assume you can't make a grocery list on your own.

I knew that real-time data on our energy use would be interesting. But I wasn't sure how much it would actually save us.

There are all kinds of distracted and compromised people in our roads. Some of them cannot help it. So why are phones a problem?

For backpackers wanting something other than solar power.

The shiny sticker generates energy from movement.

Our always-on devices turn out to consume a lot of power. Do I really need to connect my garage door to the Internet?

The ENGO charging station uses kinetic tiles and solar panels to charge up to 14 smartphones at a time, and provides free WiFi access and an emergency phone.

Smartphones hold increasing amounts of sensitive personal data, so every device is now a mixed-use device. As a result, businesses must protect employee privacy as fiercely as corporate security.

Eyeglass World launches first retail collection of smart glass technologies in the U.S., including specially designed prescription lens options and hardware for Recon, Vuzix and Epson wearable devices.

In a small trial, implanting electrodes into the brain helped women with severe anorexia gain weight and feel less anxious and depressed

UC Davis researchers have designed a plug-in interface which will usher in the new generation of compact medical devices. "We think there is a huge

As wearable fitness trackers become ever more popular and sophisticated, they provide new opportunities for monitoring training and guiding post-injury

Parents have been found to monitor only the mobile usage time and not what the kids actually see in these devices. The Content also needs to regulated,

Imports of Measure, Examine & Control Devices in Switzerland increased to 319.28 CHF Million in March from 291.73 CHF Million in February of 2020. Imports of Measure, Examine & Control Devices in Switzerland averaged 278.77 CHF Million from 2014 until 2020, reaching an all time high of 339.35 CHF Million in October of 2019 and a record low of 210.88 CHF Million in January of 2016. This page includes a chart with historical data for Switzerland Imports of Measure, Examine & Control Devices.

Imports - Machines & Devices To The Service Industries in Switzerland increased to 1069.53 CHF Million in March from 902.37 CHF Million in February of 2020. Imports - Machines & Devices To The Service Indust in Switzerland averaged 1073.81 CHF Million from 2014 until 2020, reaching an all time high of 1395.77 CHF Million in November of 2017 and a record low of 856.27 CHF Million in August of 2015. This page includes a chart with historical data for Switzerland Imports of Machines & Devices to The Service Indu.

Imports - Machines & Devices To The Equip. Of Bldg. in Switzerland increased to 195.08 CHF Million in March from 183.92 CHF Million in February of 2020. Imports - Machines & Devices To The Equip. Of Bldg in Switzerland averaged 185.61 CHF Million from 2014 until 2020, reaching an all time high of 234.78 CHF Million in July of 2019 and a record low of 138.88 CHF Million in January of 2015. This page includes a chart with historical data for Switzerland Imports of Machines & Devices to The Equip. of Bl.

Imports of Machines & Devices in Switzerland increased to 959.16 CHF Million in March from 879.28 CHF Million in February of 2020. Imports of Machines & Devices in Switzerland averaged 875.21 CHF Million from 2014 until 2020, reaching an all time high of 1022.39 CHF Million in July of 2019 and a record low of 684.19 CHF Million in January of 2016. This page includes a chart with historical data for Switzerland Imports of Machines & Devices.

Imports of Game, Sport & Leisure Devices in Switzerland decreased to 104.63 CHF Million in March from 105.43 CHF Million in February of 2020. Imports of Game, Sport & Leisure Devices in Switzerland averaged 118.29 CHF Million from 2014 until 2020, reaching an all time high of 160.43 CHF Million in September of 2019 and a record low of 79.82 CHF Million in May of 2015. This page includes a chart with historical data for Switzerland Imports of Game, Sport & Leisure Devices.

No surprise, really, that 5G smartphone sales are on the way up. Frankly, there’s really no other way to go, according to the latest numbers from NPD’s Mobile Phone Tracking. The firm noted that 5G handsets accounted for less than 1% of total sales in the U.S. The hurdles are also what you’d expect: namely, […]

The U.S. Food and Drug Administration (FDA) has authorized the manufacture of the Coventor ventilator, a new hardware design first developed by the University of Minnesota. The project sought to create a ventilator that could provide the same level of life-saving care as existing ventilator models, but with a much lower cost to help ramp […]

With Windows 10X, Microsoft introduced a new version of its flagship operating system last October that was specifically designed for dual-screen devices. The original plan was to launch the first set of Windows 10X dual-screen devices before the 2020 holidays, and in February of this year, it announced a slew of tools to help developers […]

A team of researchers from Apple and Carnegie Mellon University’s Human-Computer Interaction Institute have presented a system for embedded AIs to learn by listening to noises in their environment without the need for up-front training data or without placing a huge burden on the user to supervise the learning process. The overarching goal is for […]