On July 1, 2022, Acutus Medical (”Actus”), an arrhythmia-based medical device company, reported that it completed the first of its two closings in its left-heart access portfolio sale to Medtronic. Actus, the maker of the...more
On December 1, 2021, RefleXion Medical, Inc. (“RefleXion”), announced that the U.S. Food and Drug Administration (“FDA”) has granted the company breakthrough device designation for its biology-guided radiotherapy (“BgRT”) for...more
Before Moore, Wallach, and Hughes. Appeal from the Patent Trial and Appeal Board -
Summary: Industry skepticism is a question of fact that weighs in favor of non-obviousness and can range on a scale, with the most weight...more
On May 30, 2018, the U.S. Food and Drug Administration launched an innovation challenge as a way to combat the fight against opioid addiction. The challenge was issued to “spur the development of medical devices, including...more
According to Bloomberg, Apple, Inc. is currently developing an electrocardiogram (also known as an EKG or ECG) feature in its smartwatch products. A report from Bloomberg and other sources have stated that the unit in...more
The FDA may begin certifying the laboratories that produce lab-developed tests (“LDTs”) instead of drafting regulatory rules to cover the tests themselves....more