Medtech Companies Expand US Production To Meet Increased Demand
These expansions include millions of dollars to increase domestic manufacturing by adding new facilities and increasing capacity at existing facilities. In other news: Regeneron gets FDA green light on blood cancer drug; FDA issues alert about Abiomed blood pump controller; and more.
Modern Healthcare:
Medtech Companies Boosting Production To Meet Demand
Major medtech companies are expanding their U.S. manufacturing presence, investing millions — and in one case, billions — of dollars to boost capacity by adding facilities and expanding existing ones. Companies say they have seen increased demand for their products. Tariffs imposed by the Trump administration, along with the threat of tougher tariffs tied to a July 9 deadline, also may be a factor, although none of the companies have said so. Expanding domestic production also could offset any product shortages. (Dubinsky, 7/2)
The Wall Street Journal:
Regeneron Gets Accelerated FDA OK Of Lynozyfic For Blood Cancer Treatment
Regeneron Pharmaceuticals has won Food and Drug Administration accelerated approval of its Lynozyfic treatment for certain patients with the blood cancer multiple myeloma. Regeneron on Wednesday said the FDA green light covers Lynozyfic in adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. (Kellaher, 7/2)
Becker's Hospital Review:
FDA Flags Blood Pump Controller Issue Linked To 3 Deaths
The FDA has issued an alert about a potentially high-risk issue involving Abiomed’s Automated Impella Controller, which is used with the company’s blood pump systems. Abiomed, now part of Johnson & Johnson Medtech, notified customers June 23 with updated instructions for use and urgent recommendations, including having a backup AIC console on hand in the event of a device failure, according to a July 1 news release from the agency. (Murphy, 7/2)
MedPage Today:
Nerve-Illuminating Agent Shows Early Promise For Reducing Surgical Morbidity
A nerve-illuminating agent to minimize surgical risk passed an early test by achieving sustained fluorescence of the obturator nerve without safety concerns in patients undergoing robotic-assisted prostatectomy. (Bankhead, 7/2)
Bloomberg:
Sperm Freezing Startups Like Legacy And Fellow Take Samples By Mail
Last summer, Alexander McKinnon was always feeling tired. “I would lie on the couch at 2 in the afternoon and fall asleep,” he says. ... By September his doctor had run a blood test and found his “super fatigue” was tied to low levels of testosterone. McKinnon was prescribed steroids to boost his energy. The trade-off was that the injections would severely reduce his sperm count. McKinnon, 32, and his wife weren’t ready to start a family, but they didn’t want to risk their ability to do so in the future. “That’s when I froze my sperm,” he says. (Popescu, 7/2)
Also —
The New York Times:
454 Hints That A Chatbot Wrote Part Of A Biomedical Researcher’s Paper
Scientists know it is happening, even if they don’t do it themselves. Some of their peers are using chatbots, like ChatGPT, to write all or part of their papers. In a paper published Wednesday in the journal Science Advances, Dmitry Kobak of the University of Tübingen and his colleagues report that they found a way to track how often researchers are using artificial intelligence chatbots to write the abstracts of their papers. The A.I. tools, they say, tend to use certain words — like “delves,” “crucial,” “potential,” “significant” and “important” — far more often than human authors do. (Kolata, 7/2)
