Boston Scientific Corp.’s up to $664 million acquisition of Bolt Medical Inc. closed just days after Bolt secured U.S. FDA 520(k) clearance for its intravascular lithotripsy (IVL) system, positioning Boston Sci to challenge Johnson & Johnson’s Shockwave IVL system, which has been the only player in the market.

The U.S. FDA has cleared regenerative medicine company Orthocell Ltd.’s 510(k) for its nerve repair product, Remplir, paving the way to begin commercial operations in the $1.6 billion U.S. nerve repair market.

Some say it’s not what you say but how you say it, but the U.S. FDA’s Feb. 10, 2025, warning letter to Denver-based Exer Labs Inc., makes clear that a 510(k)-exempt device can’t be altered and promoted for claims that are disallowed under the regulation.

The on-again, off-again U.S. tariffs are off again, at least for now, for more than 75 countries that have reached out to the Trump administration to negotiate instead of retaliating. The 90-day pause will provide some breathing room for the med-tech industry. Pharmaceuticals and active pharmaceutical ingredients were among the few products exempted from the reciprocal tariffs, but that exemption for pharmaceuticals was expected to be short-lived. Meanwhile, pharma CEOs warned European Commission President Ursula von der Leyen April 8 that, unless the EU quickly changes its policy, pharmaceutical research, development and manufacturing is increasingly likely to be directed to the U.S.

In the wake of the pandemic, many leading med-tech companies took steps to on-shore and near-shore manufacturing, a move that could protect significant numbers of players from the worst of the effects of the tariffs announced by the Trump administration last week.

The April 8 Senate hearing on the Trump administration’s tariffs generated some heated debate, although U.S. Trade Representative Jamieson Greer parried some of the criticism by pointing to the yawing trade deficit.

Med tech and diagnostic companies in Europe are considering strategies to navigate the U.S. market following President Trump’s introduction of reciprocal tariffs on imports. While some companies are more exposed than others, there’s no doubt that many will feel the pain.

The U.S. NIH published the results of a study of the use of AI in referring patients for intervention for risk of opioid use disorder, which found the algorithm helped stave off hospital admissions.

Researchers from George Washington University filed for protection of a system and method that leverages generative models, specifically Variational Autoencoders, to conduct functional connectivity analysis from functional magnetic resonance imaging scans.

Women have substantially greater relative risk of major adverse cardiovascular events associated with a variety of plaque measures assessed by Cleerly Inc.’s AI-enhanced quantitative coronary computed tomography than men, an post hoc analysis of the CONFIRM2 trial found.