MedAlliance announced today that it enrolled the first patient in an erectile dysfunction (ED) feasibility study with its drug-eluting balloon (DEB). Nyon, Switzerland–based MedAlliance’s first patient was enrolled in the trial at the University of Rome Tor Vergata, Italy, under the direction of principal investigator Giuseppe Sangiorgi, a professor of cardiovascular interventional pathology. Get the full […]
Urology
The 18 most innovative medical devices of 2021
The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards. The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition. “The Awards Committee is excited to introduce the nominees for the 2021 […]
Zenflow raises $24M for minimally invasive urinary obstruction treatment
Zenflow announced over the past week that it has raised $24 million in a Series B round. The South San Francisco, Calif.–based company — which has a minimally invasive treatment for urinary obstruction caused by an enlarged prostate — also appointed Susan Stimson as its president. Stimson was a founding member of ear, nose and […]
Lucida Medical gains CE mark for cancer-detection software
Lucida Medical announced today that it received CE mark approval for its machine learning-based prostate cancer detection software. Cambridge, UK-based Lucida’s Prostate Intelligence (Pi) software offers a way for radiologists to assess and report MRI imaging studies and support the decision of whether or not to perform a biopsy, while also accurately targeting biopsies where […]
Olympus acquires Israel-based Medi-Tate
Olympus (TYO:7733) announced that it finalized the acquisition of benign prostatic hyperplasia (BPH) treatment developer Medi-Tate. The Japanese conglomerate did not disclose the financial terms of the acquisition, which was finalized after the company exercised a call option in February, according to a news release. Israel-based Medi-Tate develops the iTind device, which it designed as a […]
Axonics closes $201.3M offering
Axonics (NSDQ:AXNX) announced today that it closed a public offering of common stock worth proceeds of more than $200 million. Irvine, Calif.-based Axonics, which develops the Axonics r-SNM (sacral neuromodulation) system to treat bladder and bowel dysfunction, offered more than 4 million shares of its common stock at $50 per share, according to a news […]
Cook Medical selling powerful Quanta surgical laser in U.S.
Cook Medical announced that the Litho 150 laser from Quanta is now available in the U.S. through its distribution channels. Bloomington, Ind.-based Cook Medical said in a news release that the Litho 150 is the most recent product in Quanta’s line of laser systems and it complements Cook’s line of urologic stone management disposables. The […]
Axonics announces $150M offering
Axonics (NSDQ:AXNX) announced today that it commenced a proposed public offering of common stock worth $150 million. Irvine, Calif.-based Axonics, which develops the Axonics r-SNM (sacral neuromodulation) system to treat bladder and bowel dysfunction, also expects to grant underwriters a 30-day option to purchase up to $22.5 million in additional shares of its common stock, […]
Avenda Health wins FDA breakthrough nod for AI-based prostate cancer treatment
Avenda Health announced today that it received FDA breakthrough device designation for its AI-based male “lumpectomy” product. Santa Monica. Calif.-based Avenda designed its lumpectomy product to treat prostate cancer in-office while preserving the quality of life through AI and minimally invasive technologies, according to a news release. The Avenda Health focal therapy system spares healthy […]
UroMems adds $8.3M, brings Series B round to $27.3M
UroMems announced today that it added $8.3 million to its Series B financing round, bringing the total funds raised to $27.3 million. Grenoble, France-based UroMems’ $27.3 million (€23 million) financing round had its first tranche completed in May 2020 but added the $8.3 million (€7 million) thanks to existing investors including Hil-Invent GmbH, Financière Arbevel, […]
FDA clears point-of-care STI test
The FDA announced today that it authorized the Binx Health IO CT/NG assay at point-of-care settings to diagnose STIs. Point-of-care settings include physician offices, community-based clinics, urgent care settings, outpatient healthcare facilities and other patient care settings operating under a CLIA certificate of waiver, certificate of compliance or certificate of accreditation, according to a news […]