Empirical Spine announced that it completed enrollment in the investigational arm of its U.S. investigative device exemption trial studying its LimiFlex therapy for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The trial reached its target of 135 LimiFlex patients for the investigational arm ,and Empirical Spine plans to continue enrolling the control arm […]
DePuy Synthes issues urgent field safety notice for USS II Polyaxial 3D heads
Johnson & Johnson’s (NYSE:JNJ) DePuy Synthes issued an urgent field safety notice to initiate a voluntary recall of its USS II Polyaxial 3D heads. The recall stems from a complaint trend that reported unusual intraoperative sounds associated with use of the USS II Polyaxial 3D heads, as well as cracking of the device’s ring. Intraoperative or postoperative […]
Orthofix names former Medtronic exec to lead global spine business
Orthofix (NSDQ:OFIX) today announced that it appointed Kevin Kenny as president of its global spine business, effective Dec. 5. Kenny will be responsible for leading the global spinal implants, motion preservation, bone growth therapies and biologics businesses. “Kevin is uniquely qualified to take on this role given his prior leadership experience in the spine and medical […]
IntraVu raises $11.7m for tiny imaging system
IntraVu (Redwood City, Calif.) has raised nearly $11.7 million as it markets its tiny imaging system to doctors, according to a Form D recently filed with the SEC. The company’s single-use MIDAScope is a 1.4 mm high-definition video and photo camera on the tip of a needle. The scope, according to the company, disrupts less […]
Medtronic launches Mazor X robot surgery system in India
Medtronic (NYSE:MDT) subsidiary India Medtronic has reportedly launched its Mazor X Stealth Edition robotic guidance surgical system across India. Last week, surgeons at the Indian Spinal Injuries Centre in New Delhi used the Mazor X Stealth Edition system to successfully perform the first minimally invasive spine surgery in the country, according to a report in Express Healthcare. […]
DePuy Synthes launches new cervical spine system
Johnson & Johnson’s (NYSE:JNJ) DePuy Synthes said it has launched its Symphony occipito-cervico-thoracic system to expand its portfolio of surgical treatments for the neck and upper back. The Symphony system is designed to stabilize the spine in patients undergoing posterior cervical fusion surgery. It is meant to help streamline procedures and create efficiencies for the surgeon […]
Exactech acquires Italian distributor
Exactech (NSDQ:EXAC) announced that it acquired its independent distribution partner, Exactech Italia, creating a new corporate subsidiary. The acquisition was made official yesterday and includes all shares of the Brescia, Italy-based importer and distributor of Gainesville, Fla.-based Exactech’s orthopedic implants, instrumentation and advanced surgical technologies. Financial terms of the agreement were not disclosed but it marks […]
FDA clears Life Spine Longbow titanium lateral expandable spacer system
Life Spine announced that it won FDA 510(k) clearance for its Longbow titanium lateral expendable spacer system. The Longbow system is the first interbody on the market that expands laterally in-situ, specifically for a direct lateral approach, according to Life Spine’s website. Longbow is designed to minimize tissue retraction and potential nerve damage associated with […]
InVivo prices $1m public stock offering
InVivo Therapeutics (NSDQ:NVIV) announced that it priced a public stock offering expected to produce gross proceeds of just under $1 million for the company. The Cambridge, Mass.-based company is offering 7 million shares of its common stock to the public at a price of 12¢ per share. InVivo expects the gross proceeds to reach $840,000, before […]
Report: Appeals court revives hip implant lawsuit against Zimmer-Biomet
A federal appeals court has reinstated a personal-injury lawsuit against Zimmer Biomet (NYSE:ZBH) over a metal-on-metal hip prosthesis implanted in 2011. The Third Circuit Court of Appeals revived the lawsuit that a Pennsylvania U.S. District Court judge dismissed in August 2018 because it missed the statute of limitations, according to an article by Law 360. […]
Curiteva raises $8M for spine implant tech
Curiteva filed an SEC Form D to confirm the sale of $8 million in equity as it develops implants for complex spinal disorders. The Tanner, Ala.–based company completed the filing yesterday, confirming that nearly half of the $20 million offering was sold with 16 investors already involved and $12,000 remaining to be sold. It is […]
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