Growth in the first quarter for Boston Scientific Corp.’s blockbuster products, Farapulse and Watchman, pushed the company well over analysts’ expectations and gave management confidence to raise its guidance for the year to 15% to 17% up from 12.4% to 14.5%, despite a projected $200 million in tariff impacts.
The U.S. FDA has granted de novo clearance for Epiminder Pty. Ltd.’s Minder implantable device for continuously monitoring brain activity in patients with epilepsy.
AMT Medical BV raised $25 million in a series B financing round for its Excimer Laser Assisted Non-Occlusive Anastomosis heart bypass system. The funds will go towards clinical trials and regulatory approval for its sutureless coronary bypass technology designed to replace traditional open-heart bypass surgery.
The U.S. FDA’s authority to require cybersecurity measures in premarket submissions is a radical change for industry, but firms must document that they have erected solid cybersecurity measures.
In all practicality, U.S. FDA Commissioner Marty Makary’s recently announced policy directive removing industry representatives from the agency’s advisory committees may have little effect on the makeup of the drugs and devices committees, which typically include them as nonvoting members.
The use of Renalytix plc’s Kidneyintelx biomarker-based prognostic test led to increased and targeted use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in patients at risk of diabetic kidney disease, compared to untested patients, according to data from a study.
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