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 […]
Pre-Market Approval (PMA)
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 […]
FDA approves Abbott’s leadless pacemaker for patients with slow heart rhythms
Abbott (NYSE:ABT) announced today that the FDA approved its Aveir single-chamber (VR) leadless pacemaker for slow heart rhythms. In November 2021, the Abbott Park, Illinois-based company reported results from an FDA investigational device exemption (IDE) study that showed that Aveir met pre-specified primary endpoints in patients with certain abnormal heart rhythms, suggesting that, if approved, […]
CartiHeal wins FDA premarket approval for its Agili-C knee implant
CartiHeal announced today that it received FDA premarket approval for its Agili-C implant for treating knee joint surface lesions. Kfar Saba, Israel-based CartiHeal designed its Agili-C implant as a proprietary implant for treating cartilage lesions in arthritic and non-arthritic joints. Its PMA indication covers the treatment of an International Cartilage Repair Society (ICRS) grade III […]
FDA approves expanded indication for Abbott’s CardioMEMS
The FDA has expanded the number of people who can use Abbott’s tiny implantable CardioMEMS heart failure sensor. The approval of the expanded indication, announced yesterday, means that an additional 1.2 million people in the U.S. with heart failure could take advantage of the Abbott system. The CardioMEMS HF system remotely monitors pulmonary artery (PA) […]
Medtronic wins FDA expanded approval to use cardiac cryoablation catheters in kids
Medtronic today announced that it received FDA expanded approval for its Freezor and Freezor Xtra cardiac cryoablation catheters for pediatric atrioventricular nodal reentrant tachycardia (AVRNT). AVNRT is the most common form of supraventricular tachycardia and involves a life-threatening abnormal heart rhythm. More than a third of AVRNY cases are in pediatrics or children under the age […]
FDA approves Medtronic’s spinal cord stimulation for chronic pain from diabetic neuropathy
Medtronic (NYSE:MDT) announced today the FDA approved its Intellis and Vanta neurostimulator for treating chronic pain. The approval covers the Intellis rechargeable neurostimulator and the Vanta recharge-free neurostimulator for the treatment of chronic pain associated with diabetic peripheral neuropathy. The new indication offers DPN patients access to Medtronic’s spinal cord stimulation (SCS) portfolio of both […]
FDA approves expanded labeling for Nevro spinal cord stimulation
Nevro (NYSE:NVRO) today said it received FDA approval for expanded labeling of its Senza spinal cord stimulations system to treat non-surgical refractory back pain (NSRBP). Redwood City, California–based Nevro designed the 10 kHz therapy to improve pain relief and reduce opioid use. The 12-month results from a study of the system showed that patients who […]
FDA approves Cochlear Nucleus Implant for unilateral hearing loss, single-sided deafness
Cochlear Ltd. (ASX:COH) today announced that it received FDA approval for extended applications of its Nucleus implants. Sydney, Australia-based Cochlear designed the Nucleus implants to treat unilateral hearing loss (UHL) and single-sided deafness (SSD). The implants were already FDA approved for those with moderate to profound bilateral sensorineural hearing loss. UHL is characterized by hearing loss […]
