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.

A device that carries hot water down a tube into the gut may help manage diabetes by killing overgrown gut cells that release hormones key to metabolising food

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.

Adhesives specialist Intertronics has launched the preeflow eco-DUOMIX, a system that mixes and dispenses two-part materials.

Ashley Philipp, marketing director, Injectech, explains the importance of considering barb styles when choosing a fitting for your medical device.

Greenlight Guru, a Medical Device Quality Management Software (MDQMS) platform, has teamed up with Emergo by UL, a consulting firm specialising in global medical device regulatory compliance.

Ian Bolland spoke to Chris Risley, CEO at Bastille Networks, about medical devices at risk of being compromised by SweynTooth vulnerabilities, highlighting how hackers can be combatted from targeting devices and healthcare systems.

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

Dr Archana Nagarajan, a freelance scientist specialising in medical devices at Kolabtree, the online freelance platform for scientists, explains the changes made to the European medical device market in light of the pandemic.

FDA working with manufacturers to prevent shortages

Agency moves toward more accelerated reviews

This morning, Alydia Health, a tiny Menlo Park, Calif., startup co-founded by a 21-year-old woman, announced that it has secured $10 million in funding to test a medical device to prevent mothers from bleeding to death after childbirth.

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.

Medical device manufacturer Guidant LLC, a wholly-owned subsidiary of Boston Scientific Corporation, was charged today with criminal violations of the Federal Food, Drug, and Cosmetic Act related to safety problems with some of its implantable defibrillators.

Guidant LLC pleaded guilty today in St. Paul, Minn., before U.S. District Court Judge Donovan W. Frank to criminal violations of the Federal Food, Drug and Cosmetic Act.

St. Jude Medical Inc., a heart device manufacturer; Parma Community General Hospital; and Norton Healthcare have paid the United States $3,898,300 to resolve false claim allegations that St. Jude paid illegal kickbacks to two hospitals to secure heart-device business.

Guidant LLC, a wholly-owned subsidiary of Boston Scientific Corporation, was formally convicted and sentenced today in St. Paul, Minn., for criminal violations relating to its interactions with the Food and Drug Administration (FDA).

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.

Smith & Nephew Inc. has entered into a deferred prosecution agreement with the Department of Justice to resolve improper payments by the company and certain affiliates in violation of the Foreign Corrupt Practices Act (FCPA).

Biomet Inc. has entered into a deferred prosecution agreement with the Department of Justice to resolve improper payments by the company and its subsidiaries in violation of the Foreign Corrupt Practices Act.

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.

Orthofix Inc., a Texas-based manufacturer of medical devices, has agreed to pay the United States $34,234,263 to settle allegations under the civil False Claims Act relating to the company’s sale of bone growth stimulator devices, the Justice Department announced today. The company has also agreed to plead guilty to a felony of obstruction of a federal audit, and to pay a $7,765,737 criminal fine.

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.

ArthroCare Corporation, a medical device manufacturer based in Austin, Texas, and that trades on the NASDAQ stock exchange, has agreed to pay a $30 million monetary penalty to resolve charges that senior executives at the company engaged in a securities fraud scheme that resulted in more than $400 million in shareholder losses.

Four individuals have been charged in the Northern District of Georgia for their alleged roles in piracy groups engaged in the illegal distribution of copies of copyrighted Android mobile device applications, or “apps.”

Medical device manufacturer EndoGastric Solutions Inc. has agreed to pay the government up to $5.25 million to resolve allegations that it violated the False Claims Act by misleading health care providers about how to bill federal health care programs for a procedure using a device manufactured by the company and by paying kickbacks.

The leader of a piracy group engaged in the illegal distribution of copies of copyrighted Android mobile device applications and a co-conspirator have pleaded guilty for their roles in the scheme that distributed more than one million copies of copyrighted apps.

Members of two different piracy groups engaged in the illegal distribution of copies of copyrighted Android mobile device applications have pleaded guilty for their roles in separate schemes, each designed to distribute more than one million copies of copyrighted apps.

Ashvin Desai, of San Jose, California, was sentenced yesterday to serve six months in prison and six months and one day of home confinement for concealing more than $8 million in foreign bank accounts, the Justice Department and Internal Revenue Service (IRS) announced. Prior to yesterday’s sentencing hearing, Desai filed with the court a document indicating that the IRS has assessed and demanded payment of a Reports of Foreign Bank and Financial Accounts (FBAR) penalty against him for $14,229,744

The Justice Department announced today that it has filed a complaint against Midwest Neurosurgeons L.L.C. and its owner, Dr. Sanjay Fonn, M.D., and DS Medical L.L.C. and its owner, Deborah Seeger, for allegedly violating the Medicare Anti-Kickback Statute and the False Claims Act by conspiring to solicit and receive commissions from medical device manufacturers related to the purchase of spinal implants and supplies used during spinal fusion surgeries performed by Dr. Fonn

Three federal indictments were unsealed today in the Northern District of Georgia charging six members of three different piracy groups – Appbucket, Applanet and SnappzMarket – for their roles in the illegal distribution of copies of copyrighted Android mobile device applications, or “apps,” announced Assistant Attorney General Leslie R. Caldwell of the Justice Department’s Criminal Division, U.S. Attorney Sally Quillian Yates of the Northern District of Georgia, and Special Agent in Charge J. Britt Johnson of the FBI’s Atlanta Field Office

Vascular Solutions Inc. (VSI) has agreed to pay $520,000 to resolve allegations that it caused false claims to be submitted to federal health programs by marketing a medical device for the ablation (or sealing) of perforator veins without FDA approval and despite the failure of its own clinical trial, the Justice Department announced today

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 U.S. Food and Drug Administration granted marketing authorization to Medtronic Inc.'s CARPEDIEM System, a new device for continuous dialysis therapy for use in pediatric patients with certain kidney conditions. The system is indicated to provide continuous hemodialysis or hemofiltration therapy to critically ill pediatric patients weighing between 2.5 and 10 kilograms.

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
Hello Jose, To my knowledge, the change of O/O does not trigger a notification that needs to be confirmed, nor does it trigger a review of enforcement history.  The change of ownership and O/O is merely an administrative update that gives FDA both current information and a history of changes.  Of course, if there are known red flags with any of the involved organizations, changes can be scrutinized. Regards, James ------------------------------ James Bonds J.D. Director Regulatory Affairs Atlanta [More]

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 ------------------------------

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous Have you looked into PRA Health Sciences?

From : Communities>>Regulatory Open Forum
Hi All, Always appreciate and respect the great advice that comes through this forum: The scope of my question is CE Mark of a Class IIa medical device system under the MDD (and then eventually MDR): We have Class I devices which will be CE Marked through self-certification. These devices can be used with other CE marked products (not owned by us). One of which is not CE Marked as a medical device (conformity to machinery and low voltage directives). In terms of what we consider this vendor, what [More]

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 →