Biotechnology Medical Devices

News & Analysis as of

3D Printing Partnership: 3D Medical Limited to Acquire Mach7 Technologies

3D Medical Limited (ASX: 3DM) recently announced that it has entered into a binding Heads of Agreement (HOA) to purchase 100% of shares issued in Mach7 Technologies. According to the agreement, 3D Medical will issue 460...more

Wrap-Up of Federal and State Chemical Regulatory Developments, October 2015

On October 15, 2015, Bergeson & Campbell, P.C. (B&C®) and the Woodrow Wilson International Center for Scholars (Wilson Center) issued a report, "The DNA of the U.S. Regulatory System: Are We Getting It Right For Synthetic...more

Wrap-Up of Federal and State Chemical Regulatory Developments, September 2015

EPA Releases TSCA Assessment Documents For Flame Retardant Chemicals: On August 18, 2014, the U.S. Environmental Protection Agency (EPA) released for public comment three Problem Formulation and Initial Assessment documents...more

3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles

This white paper – 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles – explores the legal ramifications and risks of the rapidly increasing use of 3D printing of medical devices. 3D...more

The Upcoming Implementation of the Italian Patent Box Regime

Several press articles in recent weeks have anticipated the upcoming enactment of the Ministerial Decree which will eventually implement the Italian Patent Box regime. The Ministry of Economics and Finance announced on 29...more

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

Össur Announces First Mind-Controlled Prosthetic Lower Limbs

In a recent press release, Össur announced that two amputees are the first people in the world able to control their prosthetic legs with their thoughts. According to the press release, tiny implanted myoelectric sensors...more

Dechert Survey of Securities Fraud Class Actions Brought Against U.S. Life Sciences Companies

Publicly Traded Life Sciences Companies in the United States Are an Increasingly Popular Target of Securities Fraud Class Action Lawsuits - The past year was particularly noteworthy with respect to the relative number...more

Sophisticated Hackers Target Insider Information

A security consulting firm has discovered a sophisticated hacking campaign that has targeted more than 100 public companies, investment banks and law firms. In a report released December 1, cybersecurity firm FireEye...more

IMDRF Releases International Framework for Regulating Device Software

On October 14, 2014, the International Medical Device Regulators Forum (IMDRF) issued a final version of “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations” (“the...more

Software Sector Leads Pack in 2Q Venture Funding and Biotech Sector Finishes Second

Last week, the National Venture Capital Association (NVCA), a trade association representing the U.S. venture capital industry, released the results of its MoneyTree Report on venture funding for the second quarter of 2014. ...more

More of the Same: Recently Released FDA Social Media Guidance for the Life Sciences Industry

On June 17, 2014, the U.S. Food and Drug Administration ("FDA") continued to outline its expectations for pharmaceutical and medical device manufacturer use of social media platforms to promote manufacturers' products in two...more

Inside M&A - Summer 2014

“Commercially Reasonable Efforts” Diligence Obligations in Life Science M&A" - More than 80 percent of all deals in the pharmaceutical, medical device and biotech industries include an earnout structure that provides...more

FDA Targets Medical Device Companies

FDA Developing New Risk and Benefit Perception Scale - Since 2008, the U.S. Food and Drug Administration has increased its presence and tightened its control over medical device companies, and this trend is expected to...more

US China Trade War Newsletter

Dear Friends, There have been major developments in the trade, solar cells, US/Chinese antitrust, and securities areas. REASON FOR THIS NEWSLETTER - Some readers have commented that this newsletter is...more

FDA Announces Plan for Expedited Review of Certain Medical Devices

The Food and Drug Administration (FDA) published proposed guidance on April 22nd for a voluntary expedited access program for new high-risk medical devices that are intended to treat or diagnose patients with serious...more

Software Sector Leads First Quarter Venture Funding to Thirteen Year High; Biotech Sector Finishes Second (Again)

Earlier this month, the National Venture Capital Association (NVCA), a trade association representing the U.S. venture capital industry, released the results of its MoneyTree Report on venture funding for the first quarter of...more

Best Practices For Laser-Assisted Cataract Surgery

A femtosecond (FS) laser is exciting new technology, but it requires consideration of some important governance and compliance issues. Best practices require the surgeon and the facility (ASC or Hospital) to identify covered...more

Japan Enacts Regenerative Medicine Law and Revisions to Pharmaceutical Affairs Law

On 20 November 2013, the Japanese Diet passed the Act regarding Ensuring of Safety of Regenerative Medicine (the "Regenerative Medicine Law") and the revisions to the Pharmaceutical Affairs Law (new PAL) as it applies to...more

10 Tips for Medical Technology Companies

The Centers for Medicare & Medicaid Services (CMS) has initiated a new review process of existing national coverage determinations (NCDs). This new process is designed to retire old policies and may present increased risks to...more

The Life Sciences Report - Fall 2013

In this issue: - How to Expedite Examination of a Patent Application - The FDA Releases Final Guidance for Mobile Medical Applications - Creating Value in the Medtech Industry Using a Gender Lens -...more

The Sunshine Act: Putting It into Practice – Interview with Karen Lovitch, Member, Mintz Levin [Video]

Attorney Karen Lovitch, Practice Leader of Mintz Levin's Health Law Practice, discusses the challenges facing pharmaceutical and medical device manufacturers in complying with the Sunshine Act....more

CMS Posts ICD Technology Assessment

CMS has posted a new technology assessment for implantable cardioverter-defibrillators (ICDs) addressing the evidence for use of ICDs for “primary prevention” of sudden cardiac death (SCD)—prevention of SCD in patients who...more

HIPAA/HITECH Compliance Strategies for Medical Device Manufacturers

As computing power continues to become cheaper and more powerful, medical devices are increasingly capable of handling larger and larger sets of data. This provides the ability to log ever expanding amounts of information...more

Healthcare Law -- Aug 19, 2013

As the Healthcare Landscape Shifts, Four Issues Are Critical to Build Effective Market Access Strategies - In this time of high growth and fast change for the healthcare industry, pharmaceutical, biotechnology and...more

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