Swiss orthopedics company Medacta International and Geisinger Health System have said they will pilot a lifetime guarantee program for knee replacement surgeries. The program will cover full costs for screened Geisinger Health Plan members who receive knee replacement surgery while also ensuring reimbursement for any associated future care the patients may incur throughout their lifetimes. Medacta and Geisinger will […]
Think Surgical, United Orthopedic join forces for global sales
Think Surgical and United Orthopedic have announced a global joint marketing agreement of Think’s Active robotic system and United’s U2 knee system. Think’s Active robotic system consists of a 3D pre-surgical planning workstation and its computer-assisted Active robot. Its use in total knee arthroplasty is the subject of an FDA investigational device exemption study, with clearance anticipated in […]
FDA ramps up scrutiny of materials in medical devices
The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances. It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts […]
10 orthopedic products from AAOS 2019 you need to know
The American Academy of Orthopaedic Surgeons (AAOS) annual meeting in Las Vegas is abuzz about robotics, according to industry analysts from SVB Leerink. While the SVB Leerink analysts termed Stryker’s (NYSE:SYK) Mako platform “best-in-class,” it’s an expanding category. Other major orthopedics companies are using this week’s AAOS meeting to introduce new offerings or tout updates to existing […]
Miach Orthopaedics touts results of two-year study on ACL repair
Miach Orthopaedics said that a study of its bio-engineered implant for autograft anterior cruciate ligament (ACL) repair revealed results similar to those achieved by traditional ACL repair surgeries two years post-procedure. The non-randomized, two-arm study conducted at Boston Children’s Hospital enrolled 10 patients treated with Miach Orthopaedics’ bridging scaffold-enhanced ACL repair (BEAR) implant with hamstring autograft […]
FDA issues ‘leap-frog’ guidance on brain/computer interfaces
FDA has issued draft guidance for developers of devices to help amputees and people with paralysis regain mobility or their sense of touch. FDA defines brain/computer interface (BCI) devices as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities. The guidance proposes that non-clinical device testing can be used […]
Cultivate(MD) buys into magnesium alloy developer
Genesis Innovation Group‘s Cultivate(MD) Capital Fund II said that it has invested in Magnesium Development Company (MDC), a firm with a breakthrough magnesium (Mg) alloy technology for orthopedic use. MDC designed its technology to combine the strength and handling properties of metal with complete, controllable absorption. Its magnesium alloy may be used in multiple applications to provide appropriate […]
FDA slaps Class 1 designation on corneal implant recall
FDA has upgraded a recall of the Raindrop corneal inlay to Class I, the most serious designation. Developed by the now-defunct ReVision Optics, the inlay was designed to treat presbyopia. But 75% of patients in a post-approval surveillance study developed corneal hazing. ReVision closed its doors last year; RVO 2.0, doing business as Optics Medical, […]
Cultivate(MD) buys into Embody and its ortho injury implant
Genesis Innovation Group‘s Cultivate(MD) Capital Fund II said that it has invested in Embody, a startup that has developed a collagen-based microfiber implant designed for use in Achilles’ and rotator cuff repairs. Embody (Norfolk, Va.) based its Tapestry implant on research on collagen-accelerating recellularization by growing new aligned tissue over surgical repairs. The company previously […]
Study finds fault with ICD leads that Abbott inherited from St. Jude Medical
A review of FDA adverse event reports has revealed that some Abbott (NYSE:ABT) implantable cardioverter defibrillator (ICD) leads were much more likely than those made by Boston Scientific or Medtronic to fail due to internal insulation breaches (IBR). Researchers at the Minneapolis Heart Institute Foundation combed through the FDA MAUDE database from 2008 to 2018 for reports […]
Ocular Therapeutix doses first wet-AMD patient in implant trial
Ocular Therapeutix (NSDQ:OCUL) said today that it dosed the first patient in a study of its OTX-TKI tyrosine kinase inhibitor implant. The Phase I trial is slated to assess the bioresorbable device’s safety, durability and tolerability in people with wet age-related macular degeneration. Get the full story at our sister site, Drug Delivery Business News.
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