AdaptHealth (NSDQ:AHCO) announced today that it upsized and priced an underwritten offering of common stock at approximately $124 million. Plymouth Meeting, Pa.-based AdaptHealth is offering 8 million shares of its Class A common stock at $15.50 per share. The maker of home medical equipment, supplies and related services had previously set the offering at 6.5 […]
UroMems raises $17.6m
Electronic artificial urinary sphincter (eAUS) maker UroMems announced today that it raised $17.6 million (€16 million) in an equity and debt financing. Grenoble, France-based UroMems intends to use the proceeds from the funding to support ongoing preclinical studies and the initiation of the first clinical studies of its eAUS device for treating stress urinary incontinence […]
Olympus lands FDA de Novo approval for benign hyperplasia device
Olympus (TYO:7733) announced today that it received FDA de Novo classification for its iTind non-surgical device for treating benign prostatic hyperplasia (BPH). Israel-based medical device manufacturer Medi-Tate originally designed the iTind device. Olympus holds the exclusive right to distribute Medi-Tate products in the U.S. through a strategic investment. The iTind is designed as a flexible, three-strut […]
Teleflex’s UroLift wins new FDA designation
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 […]
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