Medical Devices Life Sciences

News & Analysis as of

"Trends in Corporate Integrity Agreements Reflect New HHS OIG Guidance on Use of Exclusion Authority"

2016 was a year of change for the Department of Health and Human Service's Office of Inspector General's (OIG) approach to corporate integrity agreements (CIA). The OIG began to use its new model CIA format and applied its...more

FDA Devices Center Issues Multiple Guidances in the Obama Administration’s Final Months

A flurry of regulatory activity preceded the transition in administration on January 20. Anticipating that the new administration would impose a regulatory slowdown, the Food and Drug Administration’s (FDA’s or the...more

Life Sciences. Major Russian legislation changes for 2016

We would like to present the overview of the most important legislation changes in life sciences for 2016....more

"FDA Publications Double Down on Agency’s Ability to Prohibit Off-Label Communications, but Narrow Scope of Debate"

On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such communications within...more

Life sciences patents: method claims – united they stand, divided do they fall?

Patent protection for methods claims can be tricky. Particularly for medical devices, diagnostics and even drugs, methods claims can present dilemmas for enforcement. It can boil down to the key question of "who" – who...more

FDA Issues Final Guidance on Postmarket Cybersecurity

Agency establishes a risk-based framework for assessment of postmarket cybersecurity risks for medical devices. On December 28, 2016, FDA issued a final guidance titled “Postmarket Management of Cybersecurity in Medical...more

The Life Sciences Report - Winter 2017

Consumer Digital Health: Market Shift Is Leading to New Opportunities - The newest wave of consumer digital health investment focuses on applications encouraging consumers to change health-related behaviors, shifting...more

President Obama Signs 21st Century Cures Act; Creates Accelerated Approval Pathway for Regenerative Medicine

On Tuesday, President Obama signed the 21st Century Cures Act (the “Act”) into law. The Act is a massive piece of legislation that has implications for many different aspects of the interconnected medical research, product...more

The Passage of the 21st Century Cures Act by Congress will produce Sweeping Changes to the Biotech, Medical Device,...

The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...more

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

FDA Eases Medical Evaluation and Recordkeeping Requirements for Hearing Aids

On Wednesday, the Food and Drug Administration (FDA) released a new guidance document indicating that it will not enforce the medical evaluation and recordkeeping requirements (21 CFR §801.421(a) and (d)) prior to the...more

21st Century Cures Act and Medical Device Regulatory Pathways

These seven key provisions will affect the premarket requirements for medical devices. The US Senate passed the 21st Century Cures Act on December 7, and President Barack Obama is expected to sign the bill into law....more

Highlights from McDermott’s 2016 Pharmaceutical/Medtech Dealmaking Symposium

On October 25, 2016, McDermott Will & Emery held its fifth annual Pharmaceutical/Medtech Dealmaking Symposium in Cambridge, Massachusetts. The day consisted of a series of thought-provoking panels with leading dealmakers in...more

Myriad Genetics Announces an Assay that Identifies Patients for Olaparib Treatment

Salt Lake City-based Myriad Genetics, Inc. announced that its BRACAnalysis CDx® test accurately identifies patients with ovarian cancer for a second-line treatment with olaparib. The announcement came as a result of a...more

Sanofi & Verily Launch a Diabetes Joint Venture

Sanofi, a French multinational pharmaceutical company, and Verily Life Sciences LLC (formerly Google Life Sciences), Alphabet’s U.S.-based company devoted to the study of life sciences, recently announced the launch of Onduo,...more

Top Takeaways from FDA Draft Guidance on Software as a Medical Device

FDA’s proposed adoption of an IMDRF document raises questions. On October 14, the US Food and Drug Administration (FDA or the Agency) releaseda new draft guidance document, Software as a Medical Device (SaMD): Clinical...more

Key Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies

On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more

Medical Device Investor Forum - Oct. 27-28 in Irvine, CA - Knobbe Medical

OCTANe, an Orange County-based non-profit life sciences and technology accelerator organization, has announced the agenda for its 11th Annual Medical Device & Investor Forum (MDIF), which will be held on October 27-28, 2016,...more

Product Liability Update: October 2016

Massachusetts Federal Court Dismisses Putative Class Action Because Defendant’s Unconditional Checks for Named Plaintiff’s Maximum Damages, Even Though Uncashed, Mooted Suit - In Demmler v. ACH Food Companies, Civil No....more

Review of International Regulation of Social Media Promotions at the 2016 RAPS Conference

The Regulatory Affairs Professionals Society (RAPS) held its annual Convergence conference last week in San Jose. The event certainly illustrated RAPS’s global influence given that the attendees represented many of the...more

GSK and Verily Partnering to Form New Bioelectronic Medicine Firm

GlaxoSmithKline (GSK) announced that it is partnering with Verily Life Sciences LLC to form Galvani Bioelectronics. According to the press release, GSK and Verily will contribute IP rights and an investment of $712.7 million...more

European Life Sciences Review: Issue 3

Welcome to the third issue of our European Life Sciences Review 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

New EU Rules for Medical Devices

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...more

Medtronic Acquires HeartWare for $1.1 Billion

Medtronic PLC has announced it has agreed to acquire HeartWare International Inc. for $1.1 billion in cash. According to the press release, the acquisition will expand Medtronic’s portfolio of diagnostic tools and treatments...more

NuVasive Acquires Biotronic NeuroNetwork for $98 Million

NuVasive, Inc., has announced it has agreed to acquire Biotronic NeuroNetwork for $98 million cash. According to the press release, the acquisition more than doubles NuVasive’s footprint in the neurophysiology business across...more

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