In the largest private fundraising round for a U.S. medical device company in the past year, Imperative Care Inc. closed $260 million in a series D financing round on Thursday. The company also acquired its spinoff Truvic Medical Inc., a peripheral thrombectomy developer.

Negotiations between the FDA and industry over the next device user fee are going on behind closed doors, but the agency’s summaries of these meetings suggest there are sharp disagreements. While the FDA continues to press industry on additional fees for the total product life cycle advisory program, industry’s dissatisfaction with the FDA’s fiscal management of the user fee program has prompted a demand for a one-off audit of the agency’s use of those user fees.

Heartflow Holding Inc. is aiming to bring its noninvasive, artificial intelligence (AI)-based test for coronary heart disease to more doctors and patients via a merger with Longview Acquisition Corp. II. The deal, valued at an enterprise value of about $2.4 billion, is the latest in a steady stream of med techs queueing up to go public via a “blank check” special purpose acquisition company (SPAC) this year.

Orexo AB enrolled the first patient in a pivotal trial of its digital therapeutic Modia plus sublingual buprenorphine/naloxone for treatment of opioid use disorder (OUD). Orexo’s Zubsolv, the combination of buprenorphine and naloxone used in the study, has been employed to help U.S. patients with OUD since 2013.

Med-tech mergers and acquisitions are at their highest level in four years and have already beat the full year of 2020, primarily due to a multibillion-dollar whopper completed in April. The number of industry partnerships also tower over prior years, with digital health efforts covering about 40% of the volume. Looking only at this year, the second quarter (Q2) of 2021 performed better than the first quarter (Q1) in terms of both M&As and deals.

South Korea plans to create a bio data dam, a step toward generating the necessary industrial ecosystem in the country’s bid to become one of the top seven players in the global medical device market by 2025.