Zimmer Biomet (NYSE:ZBH) last week released a letter advising hospitals and surgeons that it would be recalling various Legacy Biomet products that underwent cleaning processes that could result in elevated levels of bacterial endotoxin and residual debris. Warsaw, Ind.-based Zimmer Biomet said a supplier who performs final cleaning operations on some of its products received a […]
FDA plans advisory panel on metal implants, dental alloys
The FDA is slated to hold an advisory panel meeting to discuss immunology concerns about metal implants and dental alloys. The Immunology Devices Panel meeting of the Medical Devices Advisory Committee is scheduled for Nov. 13-14 of this year to discuss the use of the materials and assess the adequacy of current approaches and standards […]
LivaNova launches vagus nerve stim depression study
LivaNova (NSDQ:LIVN) said last week that it enrolled its first patient in a study of vagus nerve stimulation therapy for treatment-resistant depression. The Recover study is designed to determine whether active VNS therapy is a superior option compared to a no-stimulation control in producing a reduction in baseline symptom severity of depression. LivaNova plans to enroll […]
Report: Medtronic establishes $35m settlement fund for Synchromed pumps
Medtronic (NYSE:MDT) last week reportedly agreed to create a settlement fund worth some $35 million to compensate those who say they were harmed by the SynchroMed II intrathecal drug pump. The settlement involves about 500 people who claimed harm came from use of the pain-fighting pump, represented by three law firms that are negotiating individual […]
Smith & Nephew launches assurance program for Trigen Intertan hip nail
Smith & Nephew (NYSE:SNN) said yesterday that it launched the Intertan product assurance program centering on the performance Trigen Intertan intertrochanteric hip fracture nail. The Trigen Intertan device is designed to use a Smith & Nephew proprietary integrated compression screw to reduce risk of implant failure and non-union, reduce postoperative pain and increase time to […]
Convexity Scientific raises $4m Series B for Flyp nebulizer
Convexity Scientific said yesterday that it closed a Series B financing round worth nearly $4 million ahead of the launch of its Flyp nebulizer. Fairfield, Conn.-based Convexity’s funding was led by HighCape Capital with participation from Connecticut Innovations, Benslie International and Stonehenge Capital, according to a news release. The company said the funding is earmarked […]
Nemaura, Sparsha ink drug-delivery deal
Nemaura Pharma said today that it entered into a strategic collaboration with Sparsha Pharma USA for the development and manufacturing of transdermal drug delivery systems. The terms of the agreement state that Loughborough, England-based Nemaura will develop transdermal therapeutic systems at its facilities in the U.K., up to pilot clinical manufacture, for both global pharmaceutical […]
More reimbursement wins for Inspire Medical Systems
Inspire Medical Systems (NYSE:INSP) said yesterday that it received two additional draft Local Coverage Determinations for its minimally invasive therapy for sleep apnea. The latest proposals were issued by National Government Services and CGS Administrators, which represent a combined 12 states. The companies have different public comment periods, with NGS’s running from Sept. 26 to Nov. […]
Newronika raises €8m Series A for closed-loop DBS
Newronika said yesterday that it raised more than $9 million in Series A funding for its closed-loop deep brain stimulation system. The funding totals nearly $9.2 million (€8.4 million) for the spin-off from Milan’s Policlinico and University of Milan research centers. French venture capital fund Omnes led the round, joined by existing investors Innogest Capital […]
Zimmer Biomet licenses Bactiguard tech for trauma implants
Bactiguard said today that it inked an exclusive global license agreement worth up to $5 million with Zimmer Biomet (NYSE:ZBH) to apply its infection prevention technology to Zimmer’s orthopedic trauma implants. The agreement consists of an upfront license fee of $3 million and additional contingent payments of $2 million, based on clearance and royalties on net […]
Forest Devices wins 2019 MedTech Innovator competition
MedTech Innovator this week announced Forest Devices as the winner of its 2019 global competition at the annual AdvaMed MedTech conference in Boston. Pittsburgh-based Forest is developing a portable device to use electroencephalogram monitoring and machine learning to diagnose large-vessel occlusions and other stroke subtypes. The technology is designed to enable first responders to triage […]
