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
Boston Scientific has a serious stent recall problem
The FDA announced today that it deemed Boston Scientific’s recall of its VICI SDS and VICI RDS venous stent systems as Class I, the most serious kind of recall. Marlborough, Mass.-based Boston Scientific’s VICI SDS and VICI RDS venous stent systems treat obstructions and occlusions in narrowed or blocked venous veins. Get the full story at our … [Read more...] about Boston Scientific has a serious stent recall problem
Medtronic wins FDA breakthrough nod for Emprint ablation catheter kit
Medtronic (NYSE:MDT) announced today that it received FDA breakthrough device designation for its Emprint ablation catheter kit. Fridley, Minn.-based Medtronic's catheter is designed to be used in conjunction with the Emprint microwave generator and the Medtronic lung navigation platform to offer a minimally invasive, localized treatment of … [Read more...] about Medtronic wins FDA breakthrough nod for Emprint ablation catheter kit
FDA says Cordis carotid artery stent recall is serious
The FDA has classified Cordis‘ recall of its Precise Pro Rx carotid system as Class I, the most serious kind of recall. Cordis in February recalled certain lots of its Precise Pro RX carotid stent systems because of a risk of separation of the atraumatic distal tip of the sheathed delivery system in patients. Get the full story at our sister … [Read more...] about FDA says Cordis carotid artery stent recall is serious
Fresenius Kabi launches sodium chloride injection for maintaining catheter patency
Fresenius Kabi announced today that it launched two new presentations of Heparin sodium in its Freeflex IV bags. Lake Zurich, Ill.–based Fresenius Kabi’s Heparin sodium in sodium chloride injection at a concentration of two USP units per ml is indicated as an anticoagulant to maintain catheter patency, according to a news release. Get the full … [Read more...] about Fresenius Kabi launches sodium chloride injection for maintaining catheter patency
FDA grants IDE approval for Cerus Endovascular’s Contour Neurovascular System clinical study
Cerus Endovascular announced today that it received FDA investigational device exemption for a trial for its Contour Neurovascular System. Fremont, Calif.-based Cerus’ Contour Neurovascular System is designed to treat intracranial aneurysms. It is made of fine mesh braid to target the neck of the aneurysm away from the vulnerable dome. Get the … [Read more...] about FDA grants IDE approval for Cerus Endovascular’s Contour Neurovascular System clinical study
FDA clears Acutus Medical suite of universal transseptal crossing devices
Acutus Medical announced that it received FDA clearance for its AcQCross family of universal transseptal crossing devices. Carlsbad, Calif.-based Acutus touts the AcQCross system as the first and only transseptal puncture system specifically engineered to pair and mate seamlessly with Acutus' suite of sheaths, as well as with sheaths sold by … [Read more...] about FDA clears Acutus Medical suite of universal transseptal crossing devices
Medtronic stent graft recall is serious
The FDA has deemed the recall of the Medtronic (NYSE:MDT) Valiant Navion thoracic stent-graft system as Class I, the most serious kind. Medtronic's Valiant Navion is designed to repair lesions of the descending thoracic aorta. It uses a long catheter to place the stent graft inside the aorta. The stent graft expands to fit within the aorta to … [Read more...] about Medtronic stent graft recall is serious
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
Erbe Elektromedizin to acquire Maxer Endoscopy
Erbe Elektromedizin announced today that it is set to acquire Maxer Endoscopy for an undisclosed amount. Teubingen, Germany–based Erbe Elektromedizin develops, manufactures and distributes surgical instruments and devices in almost all specialist areas. Combined with other Erbe technologies, the surgical instruments are based on … [Read more...] about Erbe Elektromedizin to acquire Maxer Endoscopy
