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Xeris Pharmaceuticals, Inc. (“Xeris”) recently announced successful completion of both adult and pediatric clinical studies for its glucagon rescue pen... Read More »
Federal Circuit Summary
Before Newman, Hughes, and Stoll. Appeal from U.S. District Court for the Southern District of New York.
Summary: General... Read More »
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... Read More »
Tel Aviv-based MedyMatch Technology recently announced it has received Expedited Access Pathway (EAP) designation from the FDA for its intracranial hemorrahage (ICH)... Read More »
BioArctic AB, a public Swedish biopharma company, recently announced that they received allowance of a patent application directed to a method of promoting axonal... Read More »
On January 31, 2018, the European Commission adopted a legislative proposal with the aim of strengthening EU cooperation among Member States when conducting a Health... Read More »
The United States District Court of Western District of Washington entered a judgment in a trade secret case, Verasonics, Inc. v. Alpinion Medical Systems Co., Ltd... Read More »
The Food and Drug Administration recently announced approval of the RadioGenix™ System, a technetium 99m (Tc-99m) generator. The RadioGenix™ System... Read More »
Global medical device company Boston Scientific has announced on January 24, 2018, an agreement to make a $90 million investment in privately-held medical device... Read More »
According to IlluminOss Medical, Inc.’s recent press release, the company has successfully obtained the first-ever de novo clearance from the FDA’s... Read More »
Medtronic announced FDA approval and U.S. launch of its Intellis Platform for the management of certain types of chronic intractable pain. According to... Read More »
The U.S. Food and Drug Administration has announced approval of Abbott’s FreeStyle Libre flash glucose monitoring system for certain diabetes patients. ... Read More »
The FDA recently issued a draft guidance document intended to “to ensure that least burdensome principles are implemented for all device-related applications... Read More »
Akili Interactive recently announced results of a trial on the company’s digital medicine product, AKL-T01. According to FierceBiotech, Akili plans to... Read More »
The U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently announced that the agency plans to publish a draft guidance outlining a voluntary... Read More »
A report appearing in the December 2017 issue of Value in Health, (a journal of the International Society for Pharmacoeconomics and Outcomes Research) concluded that... Read More »
Microbot Medical Inc. announced that it entered into an agreement with CardioSert Ltd. to acquire CardioSert’s patented guidewire technology, including R&D... Read More »
Virtual reality is not just a growing trend in the entertainment industry, but is now reaching the healthcare field. As the technology improves and develops, the uses ... Read More »
On October 24, 2017, the FDA announced new steps that it is taking to promote beneficial medical device innovation.
First, the FDA completed a first qualification ... Read More »
The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices. The guidance document, which issued on December 5... Read More »