Blog Category: Blog

Intellectual Property Cases Dominate 2016 Verdict Awards

According to the annual Top 100 Verdicts report by ALM’s VerdictSearch, five jury verdicts for Intellectual Property cases cracked the top 10 with a sixth breaking into the top 25 verdicts of 2016. While the amounts do not account for

WannaCry Malware and Medical Device Security

The WannaCry virus has infected and frozen computers in many industries around the world.  According to a news source report, the virus has extorted doctors and hospital administrators for the keys to unlock and regain access to their

INC Research Merges with inVentiv Health Creating a $7.4B Combined Entity

According to press releases, INC Research Holdings, Inc. has agreed to merge with inVentiv Health, creating a combined company having an enterprise value of approximately $7.4 billion. The press release further notes that the combined

NeuroTronik Closes $23.1 million Series B Round

NeuroTronik Closes $23.1 million Series B Round

NeuroTronik, a North Carolina based subsidiary of NeuroTronik LTD of Dublin, announced that it recently closed a $23.1 million Series B funding round. The press release noted that the round was led by contributions from Boston Scientific,

Medical Device Excise Tax Remains in Limbo

Medical Device Excise Tax Remains in Limbo

President Trump and Paul Ryan (R-Wis) have not yet successfully replaced the Affordable Care Act with the American Health Care Act (“AHCA”).  The medical device industry had been paying particular attention to the proposed reform

Novartis’ Gilenya Patent Invalidated as Obvious

On April 12, 2017, the Federal Circuit affirmed the determination by the US Patent and Trademark Office (USPTO), Patent Trial and Appeal Board (Board) that the claims of  U.S. Patent No. 8,324,283 (“the ’283 patent”) were invalid

Testing of Jenex TherOZap™ Device Set to Begin

Luminar Media Group recently announced that, after completing development of a working prototype device, the Jenex Corporation has signed an agreement with the Techna Institute at the University Health Network to begin testing the TherO

Novocure Announces Optune™ Wearable Device Improves Glioblastoma Survival Rates

Novocure recently announced final results from a phase III EF-14 clinical trial of its Optune device for treatment of newly diagnosed glioblastoma (GBM).

According to Novocure’s press release, the final results of the EF-14 clinical

Certain Medical Devices Exempted from 510(k) Requirements

The Food and Drug Administration (FDA) recently identified a list of Class II Medical Devices that, when finalized, will be exempt from premarket notification (510(k)) requirements.  This publication was made by the FDA pursuant

Ingestible e-Pill Approved For Use in Hospitals

Ingestible e-Pill Approved For Use in Hospitals

BodyCap, a France-based company said to be dedicated to the development of miniature wireless electronic sensors, recently announced that its e-Celsius® device has earned CE mark approval and is now commercially available for hospital

Positive Clinical Results for Using Myriad’s BRACAnalysis CDx® for Identifying Breast Cancer Patients for Treatment with Lynaparza

Myriad Genetics recently announced clinical results showing that its BRACAnalysis CDx® test was able to identify patients with HER2-negative metastatic breast cancer who had improved response with Lynparza (olaparib), AstraZeneca’s

Outsourcing of Services in the Medical Device Industry

As the medical device market continues to grow, the medical device industry has strived to reduce costs through outsourcing. An industry report has found that the global medical device outsourcing market was valued at $33.2 billion in 2016,

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Ethicon To Acquire Torax Medical, Inc.

Ethicon Inc. announced on February 17 that it reached an agreement to acquire Torax Medical, Inc.  According to its website, Torax Medical is a privately held medical device company developing a minimally invasive surgical treatment

New Video Resources on Inter Partes Review (IPRs)

New Video Resources on Inter Partes Review (IPRs)

Since 2012, Inter Partes Review (“IPR”) has emerged as one of the most significant new procedures in patent law. An IPR is a proceeding in the Patent Office, and allows a party to challenge an issued patent on certain prior art

Potential Repeal of Medical Device Tax

With the upcoming Republican-dominated Presidency and Congress in 2017, the Affordable Care Act, or at least parts of it, look to be on the chopping block.  One of the changes that may be forthcoming is a repeal of the 2.3% medical device

Myriad Genetics Announces an Assay that Identifies Patients for Olaparib Treatment

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 clinical study

Isto Holdings Acquires Arteriocyte To Form Isto Biologics

Isto Holdings, the parent company of Isto Technologies, has acquired Massachusetts based Arteriocyte Medical Systems Inc. and the two companies will be combined under the name Isto Biologics under the current CEO of Isto Technologies,

2016 Security of Things® Forum

The third annual Security of Things® Forum (SECOT) in Cambridge, Massachusetts fostered discussion on a variety of cyber-security related topics ranging from a standards-based approach to security connected devices to connected healthcare

FDA Announces International Draft Guidance for Clinical Evaluation of Software as a Medical Device

The U.S. Food and Drug Administration announced the availability of a draft guidance for the clinical evaluation of software as a medical device (SaMD).  The draft guidance was prepared by the SaMD Working Group of the International

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