Blog Tag: Medical Devices

Former Lutonix VP Pleads Guilty to Trade Secret Theft

On May 9, 2017, according to court records, Christopher Barry, former Vice President of R&D at Lutonix Inc., pled guilty to stealing Lutonix’s trade secrets in the form of several confidential electronic files.  According to the

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

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

Voxello Receives FDA 510(k) Clearance for the Noddle Communication Device

Voxello recently announced FDA 510(k) clearance of its noddle™ device, following submission of its application in October 2016.  According to the press release, the noddle gives patients who are unable to speak a way to communicate

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,

Johnson and Johnson Insulin Pump Potentially Vulnerable to Cyber Attack

Johnson and Johnson Insulin Pump Potentially Vulnerable to Cyber Attack

Johnson & Johnson recently warned its customers of a cybcersecurity issue with one of its insulin pumps, potentially leaving thousands of users vulnerable.  According to Johnson & Johnson’s letter, “a cybersecurity

FDA Planning Board Emphasizes Use of Data Sharing in Medical Device Monitoring

The FDA‘s planned National Evaluation System for Health Technology (NEST) will focus on new forms of clinical data, data sharing, and advanced analytics as the keys to optimizing the medical device ecosystem, says 

Increase in Funding to Med Device Startups

Despite a drop in the second quarter of 2016, medical device funding is expected to finish stronger this year than in 2015.  CB Insights has released a report on the funding and deal activity within the medical device industry since

The Brexit Effect on Medical Devices

The medical device industry has been struck by a wave of uncertainty in the wake of the United Kingdom’s (UK) historic vote to leave the European Union (EU).  Until the breakup becomes official, British legislation should remain fully

FDA Issues Draft Guidance on Dissemination of Patient-Specific Information from Devices

On June 10, 2016, the U.S. Food and Drug Administration (FDA) issued draft guidance advising manufacturers on appropriate and responsible dissemination of patient-specific information from medical devices.

The draft guidance

FDA Approves AspireAssist Obesity Device

FDA Approves AspireAssist Obesity Device

On June 14, 2016, the U.S. Food and Drug Administration approved AspireAssist, an obesity treatment device that uses a surgically-placed tube to drain a portion of the stomach contents after every meal.  According to a press release

Cuba an Untapped Market for Medical Device Exports

Cuba an Untapped Market for Medical Device Exports

The United States is the world’s largest medical device exporter, according to reports accounting for $45 billion of over $140 billion in global exports in 2014.  This is not surprising since it also produced the largest share

FDA Proposes Ban on Electrical Stimulation Devices for Aggressive or Self-Injurious Behavior

On April 25, the U.S. Food and Drug Administration published a proposed rule banning electrical stimulation devices (ESDs) used to treat aggressive or self-injurious behavior.

ESDs have been used to reduce or eliminate self-injurious

Life Spine Announces FDA Clearance of PROLIFT Expandable Interbody System

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to the PROLIFT Expandable Interbody System of Life Spine.  Accordoing to its website, Life Spine is a medical device company based in Huntley, Ill., that designs,

Polymer for Celiac Disease is Confirmed as Class IIb Medical Device in European Union

According to a press release from the Israeli company BioLineRx, their novel polymer for treating Celiac Disease has been confirmed as a Class IIb medical device in the European Union (EU).  According to the company, the polymer,

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 between

Bills Introduced to Streamline FDA Review of Medical Devices

U.S. Senators Cory Gardner (R-CO) and Joe Donnelly (D-IN) recently introduced the Rare Device Innovation Act and the FDA Regulatory Efficiency Act.  The bills, if passed, would streamline the U.S. Food and Drug Administration (FDA)

Endologix, Inc. To Merge With TriVascular Technologies, Inc.

Endologix, Inc. To Merge With TriVascular Technologies, Inc.

According to a recent press release, Endologix, Inc. and TriVascular Technologies, Inc. have entered into a definitive merger agreement.  The merger, in which TriVascular will survive as a wholly-owned subsidiary of Endologix, is

Expedited Access Program Begins For Medical Devices

Expedited Access Program Begins For Medical Devices

On April 15th, the U.S. Food and Drug Administration (FDA) began its Expedited Access Program (EAP), which is designed to get certain medical devices to market sooner. Under the EAP program, device sponsors collaborate early with Center

FDA Issues Draft Guidance Document on Acceptance of Foreign Medical Device Clinical Data

The FDA recently issued a draft guidance document regarding its policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical devices.  In view of the “increasingly