Medical Devices Life Sciences

News & Analysis as of

FDA Active on the Device Front for Q1 2016

Additional guidance documents are expected. The US Food and Drug Administration’s (FDA’s) first quarter of calendar-year 2016 has been a busy one on the medical device front. FDA’s Center for Devices and Radiological...more

European Life Sciences Review: Issue 2

Welcome to the second issue of our EU life sciences alerter that covers some of the most critical developments in the pharmaceutical and medical technology sectors in the last month and is produced by our life sciences...more

AGG Food and Drug Newsletter - February 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

[Event] Do Not Enter: Privacy & Security for Life Sciences Companies - Regulatory Roundtable Immersion Series - Session #7 - Jan....

Cooley's Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant...more

Johnson & Johnson and Verily to form Verb Surgical

According to a recent press release, Johnson & Johnson announced the formation of Verb Surgical Inc., a surgical solutions company developing robotic-assisted surgical products. Verb Surgical is supported by a collaboration...more

Top takeaways from 33rd Annual IAHA Annual Meeting

On Oct. 27, 2015, the Annual Meeting of the Illinois Association of Healthcare Attorneys was held at Navy Pier in Chicago. Hundreds of health care attorneys attended, including several from Thompson Coburn. The symposium was...more

You Can Check Out Anytime You Want, But You Can Never Leave: FDA Import Detentions and Recommendations to Minimize Delays

In The Eagles’ song, “Hotel California,” Don Henley sings, “You can check out anytime you want, but you can never leave.” Life science companies can try to import all they want, but that doesn’t mean the products will make it...more

International Life Sciences Data Transfers After Schrems

With the recent ruling that the Safe Harbor programme is invalid under European law, life sciences companies will need to review their strategies when exporting patient data to the United States....more

Some Useful Insights from Steris-Synergy Merger Case

The Federal Trade Commission suffered a rare loss when, on Sept. 24, the U.S. District Court for the Northern District of Ohio denied its request for a preliminary injunction, despite having accepted the FTC’s “actual...more

TransEnterix Acquires ALF-X for $99.8 Million

Research Triangle Park, North Carolina-based TransEnterix, Inc. announced today that it has acquired the surgical robotics division of SOFAR S.p.A., an Italian health care company. According to the announcement, the deal is a...more

Cantel Acquires Medical Innovations for $79.5 Million

Cantel Medical Corp. has acquired medical device business Medical Innovations Group Holdings Ltd. for $79.5 million, according to press releases. According to its website, Cantel Medical is a global company dedicated to...more

HeartWare International To Acquire Valtech Cardio

HeartWare International recently announced that it has entered into a definitive agreement to acquire Valtech Cardio, Ltd. Yehuda, Israe-based Valtech Cardio currently provides a transcatheter mitral valve repair product for...more

Greatbatch, Inc. Completes $1.73 Billion Acquisition

Greatbatch, Inc. recently announced that it has acquired Lake Region Medical (previously known as Accellent Inc.) pursuant to a deal valued at about $1.73 billion.  Reuters reports that Greatbatch will pay $478 million in...more

Edwards Completes Acquisition of CardiAQ

According to PRNewswire, Edwards Lifesciences Corporation recently completed its acquisition of CardiAQ Valve Technologies, Inc, a developer of transcatheter mitral valve replacement systems, which follows from Edwards’...more

Highway 61 Revisited-Tombstone Blues and Corporate Integrity Agreements

I conclude my tribute to my favorite Bob Dylan album, Highway 61 Revisited with a look at the most surreal song on the disc, Tombstone Blues. I want to use it to contrast the most excellent article that appears today as a...more

HHS Proposes Major Overhaul of the Common Rule

On September 8, 2015, the Department of Health and Human Services proposed significant revisions to the Federal Policy for the Protection of Human Subjects (“Common Rule”), the set of federal regulations governing the conduct...more

Key Digital Health Investment Trends to Watch

Our fourth annual Digital Health Summit brought together a select group of investors active in the digital health, life sciences, medical device, and healthcare industries for a one-day meeting to discuss the future of...more

China’s State Council Announces Reform on the Drug and Device Approval System

China will launch new reforms of its current review and approval system for drugs and medical devices, announced by China’s State Council, in its August 18, 2015, circular Opinions Concerning the Reform of the Review and...more

China Tightens Advertising Rules for Life Sciences Companies

This year China’s Advertising Law will see its first amendment in two decades. The amendment, which will be implemented on September 1, 2015, reflects the central government’s efforts to strengthen consumer protection and to...more

FAS Russia official recommendations on the commercial policies of manufacturers of pharmaceuticals and medical devices holding a...

On June 30, 2015 on its official site FAS Russia published recommendations for entities holding a dominant position on pharmaceuticals markets and medical devices markets (hereinafter together “pharmaceutical companies”) to...more

Amarin Pharma v. FDA – More Briefs Filed Regarding Off-Label Promotion And The First Amendment

Our prior posts looked at the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit, which raises issues regarding the First Amendment and how it applies to speech by drug and device manufacturers...more

IPO Releases List of Top 300 Patent Holders for 2014 - Life Sciences Top 55

Last week, the Intellectual Property Owners Association (IPO) announced the release of its 32nd annual list of the top 300 organizations receiving U.S. patents (see "Top 300 Organizations Granted U.S. Patents in 2014"). ...more

The Life Sciences Report - Spring 2015

In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more

The Internet of Things

In this Presentation: - Internet of Things - definition - But what is it all about? - But not just that... - The IoT market in figures... - Beecham Research - view of the World - The Connected...more

Adopting a Safety Policy and Assembling a Safety Team

Large or small, every life science or medical technology company will eventually have to deal with a products liability claim or event. A lack of adequate planning for such an occurrence can result in damage to the brand,...more

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