Teleflex (NYSE:TFX) said today that the FDA has granted the company an expanded indication for the use of its UroLift system to treat larger prostates, between 80cc and100cc. UroLift is a minimally invasive, in-office treatment designed to provide rapid relief and recovery from the symptoms of benign prostatic hyperplasia (BPH), or enlarged prostate. Symptoms may […]
Study: Novel MRI-guided ultrasound treatment destroys prostate cancer
New research claims that the minimally invasive MRI-guided transurethral ultrasound ablation (Tulsa) treatment effectively treats prostate cancer with minimal side effects. The Tulsa method is designed to deliver precise doses of sound waves to diseased prostate tissue while sparing the healthy nerve tissue that surrounds the prostate. The method rivals current techniques that lack sophisticated […]
Coloplast recalls stents due to package sterility issue
Coloplast (CPH:COLO-B) recalled nine total batches of its Biosoft Duo double loop ureteral stent kit and Vortek double loop ureteral stent kit due to a packaging anomaly. Humlebaek, Denmark–based Coloplast issued an urgent field safety notice out of Germany earlier this month to warn users of the packaging issue and instruct them to review stock and […]
Potrero Medical adds $5.5m
Predictive health company Potrero Medical today filed an SEC Form D/A disclosing the sale of nearly $5.5 million in equity. The amendment the equity offering which made its first sale on June 28. At that time, the offering was for a total of $15 million and, in July, the company announced that it sold $11.7 million […]
Axonics touts one-year data for r-SNM device, inks supply deal with Nebraska urology group
Axonics Modulation Technologies (NSDQ:AXNX) said today that results from its Artisan-SNM pivotal study highlighted durable outcomes and significant improvements in patients implanted with the Axonics r-SNM system for patients with urinary and bowel dysfunction. The announcement came one day after the company said it entered into an exclusive agreement to supply the Axonics r-SNM System to […]
Profound Medical inks $8m private placement deal
Profound Medical (TSX:PRN) last week grossed nearly $8 million from a private placement with a pair of investment banks. Mississauga, Ontario-based Profound, which developed the Tulsa-Pro MR-guided prostate ablation device, said it sold a total of 9.1 million units at 83¢ (C$1.10) apiece to Canaccord Genuity and Echelon Wealth Partners for gross proceeds of about $7.5 […]
Healthy.io raises $60m in Series C funding round
Healthy.io said today that it completed a Series C financing round worth $60 million and won FDA 510(k) clearance for its smartphone-based ACR test. The funding round was led by Corner Ventures and Joy Capital, as well as previous investors Ansonia Holdings, Aleph and Samsung NEXT. The Tel Aviv, Israel-based company plans to use the […]
RenalSense’s urine flow monitoring system wins CE Mark
RenalSense today announced that it won CE Mark approval from its Clarity RMS system that monitors urine flow in critical care and perioperative settings. The Clarity RMS system continuously measures urine flow and automatically transmits real-time data and notifications of fluctuations to help with rapid intervention while monitoring treatment efficacy and fluid management. Jerusalem-based RenalSense […]
Potrero Medical raises $11.7 million
Predictive health company Potrero Medical has raised $11.7 million of a proposed $15 million, according to a Securities and Exchange Commission filing. The Hayward, Calif.-based company’s Accuryn system is designed to use urinary catheters as diagnostic tools. The device provides real-time measurements of intra-abdominal pressure, urine output and core body temperature and can be integrated […]
Taris Bio, Bristol-Myers Squibb launch bladder cancer trial
Taris Biomedical has announced the dosing of the first patient in a study of its TAR-200 system plus a programmed immune checkpoint inhibitor for the treatment of muscle-invasive bladder cancer (MIBC). The TAR-200 system continuously delivers the chemotherapy drug gemcitabine in the bladder for multiple weeks. The combination with Bristol-Myers Squibb’s Opdivo (nivolumab) will be assessed for […]
Teleflex touts large real-world UroLift study
Teleflex (NYSE:TFX) yesterday touted results from a real-world study of its UroLift system for treating prostate disease. The UroLift implant is designed to treat lower urinary tract symptoms from benign prostatic hyperplasia. Wayne, Pa.-based Teleflex paid $1 billion to acquire NeoTract, which developed UroLift, in October 2017. The 1,413-patient retrospective study was designed to evaluate UroLift’s […]
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