Endologix (NSDQ:ELGX) CEO John McDermott is planning to step down once an appropriate replacement is found, the company said yesterday as it announced fourth-quarter results that handily topped earnings expectations but missed on the top line. “Despite the business challenges over the past couple of years, I am confident that Endologix has a bright future. Our […]
Endoscopic
Three Rivers Medical wins CE Mark for Rio aneurysm embolization device
Three Rivers Medical said yesterday that it won CE Mark approval in the European Union back in October for its Rio embolization coil for treating brain aneurysms. Mountain View, Calif.-based Three Rivers said it also treated the first 10 patients with the Rio device, which is also CE Marked for peripheral embolizations. The company said it […]
Motus GI closes $18m IPO
Motus GI last week closed an initial public offering worth $18 million for its Pure-Vu system for intra-colonoscopy cleaning. Fort Lauderdale-based Motus said it plans to use the proceeds to commercialize Pure-Vu and for R&D, among other things. The company said it sold 3.5 million shares at $5 apiece, grossing $17.5 million, and also granted a 30-day […]
17 black innovators who made medtech better
From cardiology to endoscopy to blood transfusion, African Americans have played an important role as innovators in the history of medicine and medtech. To help mark African American History Month, here’s a look at some of their greatest achievements. Here are 17 black innovators who have made discoveries and invented devices to make medtech better. […]
Pentax Medical recalls ED-3490TK duodenoscopes
Hoya‘s Pentax Medical is recalling its ED-3490TK duodenoscopes looking to replace parts of the scopes to prevent leakage of patient fluids into the device, according to an FDA release. The company is looking to replace the forceps elevator mechanism, o-ring seal and distal end covering to prevent leakage of fluids into the closed elevator channel and under […]
Motus GI sets terms for $26m IPO
Motus GI yesterday set the range for its pending initial public offering, which at the midpoint would fetch nearly $26 million. Last month the Israeli company, which makes the Pure-Vu intra-colonoscopy cleaning system, registered the IPO at roughly $28.8 million. Motus GI won FDA clearance for the device in September 2016. Yesterday Motus said it plans […]
Strapped for cash, Lombard Medical defaults on loan
Strapped for cash, Lombard Medical Technologies (NSDQ:EVAR) said last week that it received a default notice from one of its lenders. The Didcot, U.K.-based stent graft maker said Oxford Finance sent the default letter Jan. 12, four days after meeting with Lombard to discuss its finances. To make matters worse, Lombard said it doesn’t have enough […]
Motus GI announces plans for $29m IPO
Motus GI said this week it intends to hold an initial public offering to raise approximately $28.8 million, according to an SEC filing. The company developed and produces the Pure-Vu cleaning system which is designed to be used with a standard colonoscope to perform intra-procedural cleaning of poorly prepared colons. Motus GI won FDA clearance for […]
Attune Medical wins 510(k) clearance for drug-delivery model of EnsoETM esophageal device
Attune Medical said today that it won 510(k) clearance from the FDA for a new model of its EnsoETM device capable of administering tube feeds or medication while regulating a patient’s temperature through the esophagus. The newly-approved model allows clinicians to maintain a patient’s core temperature while simultaneously administering fluids, eliminating the need for a separate […]
PQ Bypass wins IDE nod for Detour percutaneous femoropopliteal bypass study
PQ Bypass said today it won FDA investigational device exemption approval to launch a pivotal clinical trial of its Detour percutaneous femoropopliteal bypass system designed to treat patients with peripheral artery disease. The company’s Detour II clinical trial will look to enroll up to 292 patients with lower limb ischemia due to long blockages over 15 […]
Medtronic wins CE Mark for Endurant stent graft, HeliFX EndoAnchor combo
Medtronic (NYSE:MDT) this week won CE Mark approval in the European Union for combined treatment with its Endurant II or IIs stent graft and the Heli-FX EndoAnchor system in patients with short aortic anatomies. The combined treatment is now cleared with indications to that patients with aortic neck lengths down to 4mm with a less than […]