HeartBeam (NASDAQ: BEAT) was among the medical device companies highlighted in a Jan. 8 report by Modern Healthcare by ...
The Allurion gastric balloon can be swallowed in a 15-minute office visit and lead to a weight loss of up to 14 percent in 4 ...
The U.S. Food and Drug Administration has approved a first-of-its-kind device for the treatment of adult patients with locally advanced pancreatic cancer. Optune Pax, developed by Novocure, is a ...
The Food and Drug Administration approved its Optune Pax product, which delivers tumor treating fields, for certain ...
Optune Pax® with the chemotherapy combination of gemcitabine and nab-paclitaxel is the first treatment to be FDA approved in nearly 30 years for locally advanced pancreatic cancer.
EnVVeno Medical has received a not-approvable letter for a PMA for its VenoValve technology. The Irvine, CA-based company’s device is a surgical replacement venous valve for treating severe deep ...
FDA drug alerts in pulmonology, including drug approvals/warnings, vaccine approvals, medical device recalls/updates, and drug label updates.
The FDA has released a draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices, according to an FDA news release. The guidance is meant to ...
The FDA approved Optune Pax (Novocure), a first-in-class portable device that delivers tumor-treating fields (TTFields) to ...
The majority of medical and surgical devices used to treat children are not cleared by the Food and Drug Administration for use in pediatric populations, according to a new report from the American ...
The MarketWatch News Department was not involved in the creation of this content. White Oak, Md., Feb. 12, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration has approved a ...
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