This article has been updated with comments from the FDA and from Madris Tomes. A new investigation of FDA adverse event data has revealed that more women are harmed by medical devices than men. The report published by the International Consortium of Investigative Journalists (ICIJ) shows that among 340,000 people whom the FDA listed as […]
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 […]
Coloplast to keep interventional urology business
Coloplast (CPH:COLO-B) officials have decided to keep the company’s interventional urology business — about five months after confirming it was the subject of a strategic review. “After completing a thorough review, we have firmly concluded that the interventional urology business is core to our mission, and that retaining the business is the right decision to […]
Coloplast could sell its interventional urology business
Coloplast (CPH:COLO-B) recently confirmed that it is conducting an unconditional strategic review of its interventional urology division. That’s corporate speak for potentially selling it. The June 4 announcement came amid rumors of a potential sale. A Coloplast spokesperson had no further comments when reached by MassDevice. Coloplast’s interventional urology business grew 6% during the fiscal […]
FDA’s pelvic mesh ban spooks investors
The FDA’s ban on U.S. sales of pelvic mesh products for pelvic organ prolapse may have spooked investors, but should only have a minimal effect on the books at Boston Scientific (NYSE:BSX) and Coloplast (CPH:COLO-B) – the only companies still selling mesh for prolapse in the U.S. – according to analysts and the company. Yesterday the […]
FDA bans Boston Sci, Coloplast sales of pelvic mesh
The FDA has ordered Boston Scientific (NYSE:BSX) and Coloplast — the only remaining companies that sell pelvic mesh in the U.S. — to immediately halt sales and distribution of those products. The two companies have not demonstrated a “reasonable assurance of safety and effectiveness for these devices” used to treat pelvic organ prolapse (POP) since the […]
The Danes are coming to Medical Alley
A delegation of Denmark’s medtech and health leaders is traveling to Minnesota’s Medical Alley next week to solidify a partnership with Denmark’s MedTech Bridge. MedTech Bridge is a nonprofit program established to expand the relationship between medical device and digital health companies in Denmark and the United States and to scale commercial-stage Danish medtech businesses in the U.S. […]
Coloplast picks up French distribution co Lilial for $43m
Coloplast (CPH:COLO B) said last month it acquired French direct-to-consumer distribution company Lilial for approximately $42.8 million (EU €35.5 million). The France-based distribution company has approximately 80 employees and is expected to report sales of approximately $40 million for its full-year 2017, according to Denmark-based Coloplast. Coloplast said the acquisition is a continuation of its goal to […]
Coloplast acquires Comfort Medical for $160m
Coloplast (CPH:COLO B) said today it inked a definitive agreement to purchase urological device supplier Comfort Medical for $160 million. Comfort Medical is a direct-to-consumer dealer of durable medical equipment including catheters and ostomy supplies, and Coloplast said the acquisition “is a continuation” of its ambition to bring innovative products and services to the US market. […]
Report: Coloplast looks to expand in Minnesota
Coloplast (CPH:COLO B) is looking to expand its worker base in Minnesota, according to a new report from the Twin Cities Business Mag. The company, which acquired the urology business mentor Minnesota in 2006, has its North American headquarters in Minneapolis, Minn. with 310 employees in the area. Coloplast is looking to add an additional 3,000 staff […]
Coloplast hails U.K. growth but cuts outlook on weak pound
(Reuters) — Denmark’s Coloplast (CPH:COLO B) overcame problems in Britain to post what it described as highly satisfactory growth in its largest market, lifting its shares, though it trimmed 2016 sales guidance on sterling weakness ahead of Britain’s referendum on EU membership. The company, which makes ostomy bags, wound dressings and penile implants, said it is […]
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