Glaukos (NYSE:GKOS) recently announced that it received regulatory approval from Australia's Therapeutic Goods Administration for its Preserflo MicroShunt. The San Clemente, Calif.–based company designed the MicroShunt to reduce intraocular pressure in the eyes of patients who have primary open-angle glaucoma where IOP remains uncontrollable or … [Read more...] about Glaukos wins Australian regulatory approval for MicroShunt
Implants
How Abbott engineered a catheter-delivered device for premature babies
Abbott’s experience designing its Piccolo device provides essential lessons for medical device creators who want to spark a pediatric medical device renaissance. The Amplatzer Piccolo occluder from Abbott is one of the first medical devices that health providers can implant in premature babies weighing as little as 2 lb to treat patent ductus … [Read more...] about How Abbott engineered a catheter-delivered device for premature babies
Olympus acquires Israel-based Medi-Tate
Olympus (TYO:7733) announced that it finalized the acquisition of benign prostatic hyperplasia (BPH) treatment developer Medi-Tate. The Japanese conglomerate did not disclose the financial terms of the acquisition, which was finalized after the company exercised a call option in February, according to a news release. Get the full story at our … [Read more...] about Olympus acquires Israel-based Medi-Tate
Micro Interventional Devices tricuspid annuloplasty system wins FDA breakthrough device designation
Micro Interventional Devices today said it received FDA breakthrough device designation for its MIA-T percutaneous tricuspid annuloplasty system. The MIA-T system treats moderate to severe tricuspid regurgitation through a 12F catheter-based system. Micro Interventional Devices studied the safety and performance of the device in a study … [Read more...] about Micro Interventional Devices tricuspid annuloplasty system wins FDA breakthrough device designation
atHeart Medical launches atrial septal defect occluder trial
AtHeart Medical is initiating a U.S. investigational device exemption trial for its atrial septal defects (ASD) occluder. The reSept ASD Occluder is an occluder with a metal-free, bioresorbable frame. The implant is designed to overcome the limitations of occluders by reducing the risk of complications associated with the long-term presence of … [Read more...] about atHeart Medical launches atrial septal defect occluder trial
Endologix acquires PQ Bypass
Endologix today announced that it has completed its acquisition of PQ Bypass for an undisclosed amount. PQ Bypass makes the Detour platform that is designed for percutaneous femoral-popliteal bypass, which has been designated as a breakthrough device by the FDA. The Detour system has the company’s Torus stent graft and the PQ crossing device. … [Read more...] about Endologix acquires PQ Bypass
Abbott Xience stent gains expanded CE mark
Abbott (NYSE:ABT) announced today that its Xience stent received CE mark approval for a shorter duration of dual anti-platelet therapy (DAPT). The European approval for the stent allows for the DAPT to go as short as 28 days, the shortest indication available in the world for patients with high bleeding risk (HBR), according to a news … [Read more...] about Abbott Xience stent gains expanded CE mark
4 innovative devices delivered through catheters
Physicians use catheters to deploy numerous life-saving devices across the healthcare realm, from cardiovascular to neurovascular. They typically insert the thin, flexible tubes in a process called catheterization to deploy devices such as left ventricular assist devices (LVADs), transcatheter aortic valve replacements (TAVRs) and occluders to … [Read more...] about 4 innovative devices delivered through catheters
Ambu single-use endoscope wins Frost & Sullivan innovation award
Frost & Sullivan today announced that it awarded Ambu with a 2021 Global New Product Innovation Award. Ambu received the award for its single-use flexible endoscopes that are designed to make the devices safe, affordable and accessible. It has aView and aBox all-in-one video displays that eliminate the traditional video endoscopy tower size … [Read more...] about Ambu single-use endoscope wins Frost & Sullivan innovation award
The worst catheter-based device recalls of 2020
The U.S. saw nine serious medical device recalls related to catheters in 2020 — up from four the previous year, according to the FDA. The agency 2020 tagged a total of 33 medical device recalls as Class I — the most serious level — down from 49 in 2019. The list of the most serious catheter-based device recalls in 2020 includes products from … [Read more...] about The worst catheter-based device recalls of 2020
