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Boston Scientific Announces Acquisition of EMcision

March 8, 2018 Sean S. Kim

On March 5, 2018, Boston Scientific announced its acquisition of EMcision, a privately held company in the United Kingdom and Canada. According to Boston Scientific, this acquisition will expand its range of medical devices in the field of minimally invasive endoluminal procedures as alternatives to conventional surgery.

FDA Approves Blood Test for Concussion

March 16, 2018 Nathan J. Lee

The U.S. Food and Drug Administration has announced approval of Banyan Biomarkers, Inc.’s Banyan BTI (Brain Trauma Indicator) under the FDA’s De Novo premarket review pathway.   According to the press release, Banyan BTI is the first in vitro diagnostic blood test for the evaluation of mild traumatic brain injuries (mTBI), commonly referred to as concussions, authorized for marketing by the FDA.

Johnson & Johnson Acquires French Surgical Tech Firm Orthotaxy

March 2, 2018 Chang Lim

On February 20, 2018, Johnson & Johnson Medical Devices Companies announced the acquisition of Orthotaxy, a privately-held developer of software-enabled surgery technologies, including a differentiated robotic-assisted surgery solution.

Improper Markush Rejection: The New Kid on the Patent Block

March 1, 2018 Jane Xia

The U.S. Patent and Trademark Office (“USPTO”) quietly increased the examiners’ arsenal by slipping a new rejection into the latest revision of the Manual of Patent Examining Procedure (“MPEP”) released last month. One of the changes made in this revision is the addition of a new “improper Markush grouping” section, MPEP § 706.03(y), which authorizes patent examiners to reject a claim on the basis that it contains an improper listing of alternative elements.

Xeris’ Pharmaceuticals Glucagon Progresses Towards FDA Approval

February 28, 2018 Aaron S. Johnson

Xeris Pharmaceuticals, Inc. (“Xeris”) recently announced successful completion of both adult and pediatric clinical studies for its glucagon rescue pen.

U.S. to Have its Own Supply of the Most Commonly Used Medical Imaging Isotope for the First Time in 30 Years

February 27, 2018 Noorean I. Gill

Medical imaging isotopes are used to diagnose various diseases, such as cancer and coronary artery disease, and to evaluate brain, lung, kidney, and liver function.  According to an U.S. Food and Drug Administration (FDA) press release, the most widely used medical imaging isotope, Technetium-99m (Tc-99m), is used in over 80% of the United States’ nuclear medical imaging procedures.  

FDA Clears New Surgery Infection Control System

February 26, 2018 Sean S. Kim

The FDA recently cleared Prescient Surgical’s CleanCisionTM  Wound Retraction and Protection System (CleanCisionTM), a retractable device designed to prevent surgical site infection.

Da Volterra Develops Device to Combat Antibiotic Resistance

February 11, 2018 Mark Rubinshtein, Ph.D.

Da Volterra, a biotech company developing products in the antibacterial field, has announced results in a human clinical trial for DAV132, a product said to prevent life-treating bacterial infections during antibiotic treatments.

FDA Approves NorthStar’s Tc-99m Generator

February 23, 2018 Robert J. Hilton, Ph.D.

The Food and Drug Administration recently announced approval of the RadioGenix™ System, a technetium 99m (Tc-99m) generator. The RadioGenix™ System is developed by NorthStar Medical Radioisotopes, LLC, a nuclear medicine technology company.

Seizure-Detecting Smart Watch Given FDA Approval

February 22, 2018 Nathan D. Reeves

The FDA has recently approved Embrace, a smart watch designed to monitor epileptic patients for seizures, according to a press release. According to the press release, the device uses machine learning to monitor patients for dangerous seizures, including grand mal or generalized tonic-clonic seizures.

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