Brain Scientific Inc. plans to acquire Piezo Motion Corp. in an all-stock transaction expected to close in July 2021. The deal depends in part on the successful closing of a $5 million funding round. At closing, Brain Scientific will acquire 100% of Piezo’s outstanding shares along with its assets and liabilities. Piezo Motion’s shareholders will receive the number of shares of Brain Scientific’s common stock equal to 100% of its issued and outstanding shares immediately prior to closing on a fully diluted, as converted basis.

The FDA responded on Thursday to longtime industry calls for the agency to clarify the distinction between the “serving” and “remanufacturing” of a medical device with new draft guidance to provide consistency and a better understanding of the applicable statutory and regulatory requirements. The 35-page document details its current thinking on the distinction.

Diagnostics powerhouse Danaher Corp. has agreed to buy Aldevron LLC, a privately held biotech company that supplies a key ingredient for COVID-19 vaccines, from EQT VIII Fund for $9.6 billion in cash. Based in Fargo, N.D., with additional operations in Madison, Wis., Aldevron makes high-quality plasmid DNA, mRNA and recombinant proteins used in vaccines, gene and cell therapy, gene editing and diagnostic applications.

As demand for artificial intelligence (AI)-driven health assessment platforms grows, software developer Ada Health GmbH has signed more than 10 new partnerships with key players across life sciences, insurance and health systems. These include pharmaceutical partners Takeda Pharmaceutical Co., Sanofi SA, Alnylam Pharmaceuticals Inc., as well as Taj Digital Health, Sutter Health, and more.

With the advent of wearable digital health technologies, patient-generated health data (PGHD) will play an increasingly central role in evidence generation for medical device companies. Speakers on a recent FDA workshop advised that there are several barriers to the use of PGHD for evidence generation, however, such as the perennial headache of data interoperability and a new twist on the question of patient trust, problems that are likely to plague the field for the foreseeable future.

PERTH, Australia – Digital cognitive assessment technology company Cogstate Ltd. saw its stock skyrocket 60% on the heels of FDA accelerated approval of Biogen Inc./Eisai Co. Ltd.’s Alzheimer’s disease drug Aduhelm (aducanumab). Cogstate and Eisai signed a deal in October 2020 that granted Eisai global development rights and exclusive commercialization rights of all cognitive function tests developed by Cogstate.

The largest med-tech M&As so far in 2021 have bumped the year’s value well above this point last year, although none come close to the October merger of Teladoc Health Inc. and Livongo Health Inc. for $18.5 billion. Still, 2021 appears on track to exceed 2020’s $38 billion M&A total, with 227 completed M&As already valued at $25 billion, 66% of 2020’s full-year amount.