Medtronic plc received U.S. FDA approval for its Omniasecure defibrillation lead for placement in the right ventricle to treat arrhythmias. Medtronic said the lead is the smallest made at 4.7 French or 1.6 mm, making it suitable for individuals as young as age 12 and others with smaller anatomies, particularly women.
Celldex Inc.’s KIT inhibitor, barzolvolimab, which hit its phase II endpoints in late 2023, kicking off phase III development in chronic spontaneous urticaria, offered up some impressive long-term findings at the EAACI Congress 2025, including complete responses in patients for as long as seven months after the cessation of therapy, which analysts said could position the drug as a potentially best-in-class option.
Boston Scientific Corp.’s Farapulse pulsed field ablation system racked up more than $1 billion in revenue in its first year; its Watchman left atrial appendage occluder holds more than 90% of the market. How does the company choose and position its products for such astonishing success?
Med-tech veterans advised companies looking to launch new products in fields with dominant players to mind their 'Ps and Qs,' but not the ones your mother drilled in childhood. Rather than good manners, they urged competitors attending Device Talks Minnesota to ensure they had the right people, product, proof, pace and quality control.
Researchers from Virginia Polytechnic Institute and State University filed for protection of their development of a slim, painless, and affordable microfluidic infusion pump device for the continuous transdermal delivery of drugs.
And then there were eight. That is, eight members of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP).Two days after dismissing the 17 members of the committee, Health and Human Services Secretary Robert Kennedy named eight new members to the panel. Eight is the minimum required for a quorum, which will be necessary for the June 25-27 ACIP meeting.
Cullinan Therapeutics Inc. swept up ex-China rights to a multiple myeloma-targeting BCMAxCD3 bispecific T-cell engager (BiTE) velinotamig from Chongqing Genrix Biopharmaceutical Co. Ltd. via a potential $712 million deal June 4. The plan is to repurpose the cancer drug to autoimmune disease.
Slightly ahead of the assigned June 23 PDUFA date, Nuvation Bio Inc. scored the U.S. FDA’s go-ahead for Ibtrozi (taletrectinib) to treat adults with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).
The bankruptcy of genetic testing service 23andme Holding Corp. prompted a reaction from many quarters, but a June 11 Senate hearing highlighted an interest in federal privacy legislation that would be directed toward genetic privacy as well as comprehensive and preemptive federal privacy legislation.
The bankruptcy of genetic testing service 23andme Holding Corp. prompted a reaction from many quarters, but a June 11 Senate hearing highlighted an interest in federal privacy legislation that would be directed toward genetic privacy as well as comprehensive and preemptive federal privacy legislation.
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