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 […]
Medtronic launches GI Genius AI colonoscope
Medtronic (NYSE:MDT) said yesterday that it launched the GI Genius endoscopy module for detecting colorectal polyps in the treatment of colorectal cancer. The GI Genius is designed to use artificial intelligence to highlight pre-cancerous lesions with a visual marker, something Medtronic said can increase colorectal polyp detection rates. The Fridley, Minn.-based company said it is the […]
9 early medical devices that will horrify or amaze you
The movie Frankenstein inspired eight-year-old Earl Bakken to consider how electricity could restore life and health to the human body. Bakken went on to invent the first external cardiac pacemaker and to co-found medtech giant Medtronic in 1949. Bakken’s fascination with the effects of electricity on the human body continued throughout his career, and he amassed a collection of […]
JAMA: Minimal safety benefit for robot-assisted colectomies
A study of robot-assisted colectomies found that the procedure offered minimal safety benefit compared with laparoscopic colectomy and should continue to be questioned by surgeons and hospitals. The trial was conducted because of the rapid increase in robotic surgery for common operations like colectomy, combined with a lack of evidence regarding its effectiveness. It was […]
GE Healthcare to market Theragnostics’ new PET/CT imaging agent for prostate cancer
GE Healthcare (NYSE:GE) said today that it entered into a global commercial partnership with Theragnostics for its prostate-specific membrane antigen PET/CT imaging agent. The agreement stipulates that Theragnostics is to lead the development of the GalliProst diagnostic tracer, while GE Healthcare is slated to lead pre-approval commercial preparations, plus all commercial and distribution activities after […]
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 […]
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