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 […]
Boston Scientific touts SpaceOAR meta-analysis results
Boston Scientific (NYSE:BSX) announced that published results from an analysis of its SpaceOAR hydrogel spacer revealed safe prostate-rectum separation. Marlborough, Mass.-based Boston Scientific has developed the SpaceOAR since its $600 million acquisition of Augmenix in September 2018. The absorbable polyethylene glycol hydrogel spacer won CE Mark approval in the European Union in 2010 and 510(k) clearance from the […]
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 […]
Ibex wins CE Mark for AI-powered cancer detection software
Ibex Medical Analytics announced today that it won CE Mark approval for its artificial intelligence-powered Galen Prostate software for identifying suspected cancer on prostate core needle biopsies. Tel Aviv-based Ibex touts its Galen prostate solution as the first-ever AI-based software for cancer detection used in routine clinical practice, and it is already deployed in pathology […]
Colospan wins IDE FDA approval for intraluminal bypass device
Colospan announced today that it won FDA investigational device exemption for its CG-100 temporary intraluminal bypass device for gastrointestinal resection procedures. Following the IDE win, Israel-based Colospan plans to launch its pivotal study for the CG-100 device, which is designed to reduce diverting stoma rates in patients undergoing those resection procedures. In comparison to diverting […]
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 […]
Concept Medical wins CE Mark for MagicTouch DCBs
Concept Medical said yesterday that it received CE Mark approval for three versions of its MagicTouch sirolimus-coated balloons. The MagicTouch PTA for peripheral artery disease, MagicTouch ED for erectile dysfunction and MagicTouch AVF for arterio-venous fistula and graft all received approval in Europe, according to a news release. Get the full story at our sister […]
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