FDA approves mFLUSIVA, the first mRNA-based flu vaccine for adults 50 and older
Moderna adds a fourth FDA-approved product as mRNA technology moves beyond COVID-19
Zeta Surgical gets FDA clearance for its robotic TMS targeting system
The Boston startup's robotic platform promises submillimeter accuracy for transcranial magnetic stimulation, with setup times under a minute
Health Universe raises $6M to bring AI workflow automation to hospitals
The platform connects medical records to AI agents, helping health systems deploy automated workflows in days instead of months
Samsung Galaxy Watch teams up with Verily to speed up clinical trials
The partnership combines consumer wearables with AI-powered health analytics to make medical research easier and more accessible
Switzerland to accept medical devices certified by the FDA
The Swiss parliament made an urgent and necessary decision paving the way for accepting medical devices certified by the FDA.
FDA’s digital health pre-certification pilot program is now open for applications
The focus of the Pre-Cert program is not on particular products but on firms and developers, which in turn (if pre-certified) will be able to more easily certify all of their products.
Senseonics’ Eversense CGM System receives CE Mark approval
The system includes an implanted glucose sensor that lasts up to 90 days, a wearable smart transmitter to calculate glucose levels, and a mobile app.
Gauss Surgical’s receives CE mark for its surgical blood loss system
The company's flagship offering Triton scans surgical sponges and blood bearing canisters to estimate the amount of blood contained in them.
St. Jude’s Infinity Deep Brain Stimulation System receives CE mark
The Bluetooth-enabled system is made for people suffering from Parkinson's, tremor and dystonia; it comes in two sizes to better match patient needs...
FTC wants Apple’s guarantees over health data use
The idea is to prevent usage of sensitive health data collected by Apple's upcoming smart watch and the HealthKit platform without owners' consent.