France-based EDAP TMS SA will get its day with the FDA next month, when the agency’s expert advisors will review EDAP’s Ablatherm-HIFU therapeutic ultrasound technology for treatment of prostate cancer.
NxThera said it closed a $20 million Series C round that topped its initial $18 million target.
Maple Grove, Minn.-based NxThera won CE Mark approval in the European Union last August for its Rezūm prostate device, which uses steam to reduce the size of the prostate to relieve urinary symptoms from benign prostate hyperplasia.
C4 Imaging won clearance from the FDA for its 1st product, the Sirius Positive Signal MRI marker, designed for use following the treatment of prostate cancer with brachytherapy.
The MRI marker is designed to facilitate seed localization within the prostate, utilizing a single post-implant MRI procedure.
Brachytherapy involves implanting around 100 radioactive seeds into the prostate. It has risen in popularity because the treatment is considered more effective and convenient, according to the press release.
Profound Medical said it won an investigation device exemption from the FDA for a clinical trial of its device to treat prostate cancer.
The Toronto-based medical device company said it hopes to begin enrolling patients later this year in the Tulsa trial.
The Profound device combines thermal ultrasound with real-time MRI guidance in a single outpatient session to treat localized prostate cancer, according to a press release.
Routine screening has been touted as the most effective way to stem cancer deaths, but it may instead put patients in harm’s way, according to American Cancer Society chief medical officer Dr. Otis Brawley. Speaking at a seminar last week, Brawley warned that hospitals recommending regular screening may be looking out for their profits rather than their patients.