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
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
AngioDynamics mechanical thrombectomy system wins FDA clearance
AngioDynamics (NSDQ:ANGO) today said it received FDA 510(k) clearance for its AlphaVac mechanical thrombectomy system. AlphaVac is an off-circuit, multi-purpose mechanical aspiration thrombectomy device for the non-surgical removal of thrombi or emboli from the vasculature. Latham, N.Y.-based AngioDynamics designed the system with a … [Read more...] about AngioDynamics mechanical thrombectomy system wins FDA clearance
EvoEndo raises $10M for unsedated transnasal endoscope
EvoEndo today said it secured $10.1 million in equity financing to develop its unsedated transnasal endoscopy system. The Denver-based company's funding round included family offices and early-stage life science investors. EvoEndo's transnasal endoscopy (TNE) system is a sterile, single-use, flexible endoscope with VR-based patient … [Read more...] about EvoEndo raises $10M for unsedated transnasal endoscope
CardioFocus, China Grand Pharmaceutical partner to commercialize catheter ablation system in China
CardioFocus today announced a licensing and distribution agreement with China Grand Pharmaceutical to seek regulatory approvals for the HeartLight X3 catheter ablation technology in China. Marlborough, Mass.–based CardioFocus designed the HeartLight X3 system for controlled and consistent pulmonary vein isolation, which is the primary treatment … [Read more...] about CardioFocus, China Grand Pharmaceutical partner to commercialize catheter ablation system in China
Preceptis Medical launches tympanostomy tube system for in-office pediatric ear tube procedures
Preceptis Medical today said it has launched its second-generation Hummingbird tympanostomy tube system for office-based pediatric ear tube procedures. The Maple Grove, Minn.–based company designed the device with an ergonomic design to allow for more efficient ear tube delivery in children. “The Hummingbird enables ear, nose and throat (ENT) … [Read more...] about Preceptis Medical launches tympanostomy tube system for in-office pediatric ear tube procedures
Envizion Medical wins Frost & Sullivan award
ENvizion Medical announced it has won the Frost & Sullivan 2021 North American Technology Innovation Leadership Award for its ENvue system. Israel-based ENvizion Medical has developed the feeding tube navigation system for accurate enteral tube placement in adult patients as an alternative to the limitations of blind insertions and the … [Read more...] about Envizion Medical wins Frost & Sullivan award
Resonetics acquires Distal Solutions
Resonetics today said it completed its acquisition of Distal Solutions for an undisclosed amount. Distal Solutions specializes in the design and development of catheter-based delivery systems for medical devices and implants. Distal's founder David Rezac will lead Resonetics's design and development efforts and California market … [Read more...] about Resonetics acquires Distal Solutions
Cardiovascular Systems launches peripheral balloon catheter
Cardiovascular Systems (NSDQ:CSII) today said it has launched its OrbusNeich Jade percutaneous transluminal angioplasty over-the-wire balloon catheter in the U.S. Jade is an over-the-wire (OTW) balloon catheter for the peripheral vasculature, including obstructed native arteries and synthetic arteriovenous dialysis fistulae and post-dilation of … [Read more...] about Cardiovascular Systems launches peripheral balloon catheter
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
