Abiomed (Nasdaq:ABMD) announced today that the FDA granted its Impella RP Flex with SmartAssist pre-market approval (PMA). Danvers, Massachusetts-based Abiomed designed the Impella RP Flex with SmartAssist to treat right heart failure. It does so for up to 14 days. The company intends to introduce Impella RP Flex in the U.S. through a controlled launch […]
Pre-Market Approval (PMA)
Abiomed reaches new regulatory milestone for its Impella pumps
Abiomed (Nasdaq:ABMD) announced that the FDA accepted and closed its post-approval study reports for its Impella heart pumps. Danvers, Massachusetts-based Abiomed’s study reports relate to Impella’s premarket approvals (PMA). The company said in a news release that the FDA’s action represents “another affirmation” of the safety and effectiveness of Impella heart pumps. Impella pumps treat […]
FDA approves Medtronic drug-eluting stents for treating bifurcation lesions
Medtronic (NYSE:MDT) announced today that the FDA approved its Onyx drug-eluting stents (DES) for treating certain lesions. Approval covers the treatment of non-left main bifurcation lesions utilizing the provisional bifurcation stenting technique. The technique uses a single stent to treat the bifurcation in percutaneous coronary interventions (PCIs). It applies to the FDA-approved and CE-marked Onyx […]
Edwards wins FDA approval for Pascal Precision transcatheter valve repair system
Edwards Lifesciences (NYSE:EW) announced today that the FDA approved its Pascal Precision system for patients with degenerative mitral regurgitation (DMR). The implant and transcatheter delivery system represent Edwards’ bid to compete with Abbott and its MitraClip in the DMR treatment space. Irvine, California-based Edwards Lifesciences designed its Pascal Precision system for precision transcatheter edge-to-edge repair […]
FDA approves AcuFocus intraocular lens for cataract surgery
AcuFocus announced today that it received FDA approval for its IC-8 Apthera intraocular lens for the treatment of cataracts. Irvine, California-based AcuFocus said in a news release that the Apthera IOL represents the first and only non-toric, extended depth of focus IOL approved for the 82% of cataract patients who have as much as 1.5 […]
FDA approves expanded, full-body MRI compatibility with Inspire therapy
Inspire Medical Systems recently announced that FDA has approved additional MRI scan conditions for use with Inspire therapy Minneapolis-based Inspire Medical is the maker of a minimally-invasive, implantable device that uses neurostimulation to treat obstructive sleep apnea. Company officials in a July 6 news release said the full-body MRI approval expands the Inspire use labeling. […]
FDA approves Medtronic’s In.Pact 018 drug-coated balloon catheter
Medtronic (NYSE:MDT) announced that it received FDA approval for its In.Pact 018 paclitaxel-coated balloon catheter. Fridley, Minnesota–based Medtronic’s In.Pact 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter, a drug-coated balloon product, received an indication for the interventional treatment of peripheral arterial disease (PAD) in the superficial femoral and popliteal arteries. According to a news release, […]
Orthofix wins FDA PMA for bone growth stimulation device
Orthofix (Nasdaq:OFIX) announced today that it received FDA premarket approval (PMA) for its AccelStim bone healing therapy device. Lewisville, Texas-based Orthofix designed the AccelStim device to provide a safe and effective nonsurgical treatment for indicated fresh fractures and for fractures that have not healed (nonunions). According to a news release, the device generates a low-intensity […]
FDA approves Transmedics OCS Heart organ transplant system
TransMedics (Nasdaq:TMDX) announced today that it received FDA premarket approval (PMA) for its OCS Heart system. FDA PMA allows Andover, Massachusetts-based TransMedics to expand the pool of eligible heart donors in the U.S. to organs from donors after circulatory death (DCD). The company had previously received PMA for the OCS Heart system for use with […]
FDA approves GE Healthcare software that automates anesthesia, reduces greenhouse gas emissions during surgery
GE Healthcare recently announced that it received FDA premarket approval for its End-tidal (Et) Control software for general anesthesia delivery. The software is approved for use with GE Healthcare’s Aisys CS2 anesthesia delivery system. The Chicago-based company initially released the technology in Europe in 2010 and is currently used in over 100 countries. Get the […]
Bioventus plans to buy CartiHeal for at least $315M to launch knee implant
Bioventus (Nasdaq: BVS) today said it plans to buy CartiHeal following the FDA’s recent premarket approval of the Israel-based medtech developer’s Agili-C implant. Durham, North Carolina-based Bioventus will pay about $315 million to buy the company, excluding the stake already owned by Bioventus after it made a $50 million escrow payment last year. The deal also […]
