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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
Cancer Research UK took a significant hit when its U.K.-wide charity shop chain had to close last year because of the pandemic. But, according to latest figures, its commercial arm could help it to bounce back after seeing its income more than double in the recent biotech boom. The organization reported record levels of investment in its spinout companies, which more than doubled in 2020-2021 compared with the previous year, jumping from £400 million (US$555 million) to £822 million (US$1.14 billion) Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Accure Health, Active Implants, Nexus Medical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ablynx, Alpha Innomed, Avicenna.ai, Axle Health, China Resources, Digital Science, Elitechgroup, Ginger.io, Gonotec, H.E.L. Group, Labgenius, Lifemd, Medaxiom, Novari, Ontochem, Topcon, Visia, Viz.ai. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Istar Medical, Palliare. Read More
