NuVasive (NSDQ:NUVA) announced today that it received FDA approval for its Simplify disc in two-level cervical total disc replacement (cTDR). San Diego-based NuVasive’s Simplify cervical artificial disc, part of its NuVasive C360 portfolio, is comprised of PEEK on ceramic materials to allow for enhanced visualization through MRI postoperatively when compared to alternative devices, according to […]
Implants
MTF Biologics says FDA used old data to malign its surgical mesh
A surgical mesh company claims the FDA improperly called one of its products’ safety into question. The agency said last week that two surgical mesh brands used off-label in breast reconstruction surgery have had “significantly higher major complication rates.” It named FlexHD by MTF Biologics and AlloMax by BD as having had higher rates of explantation, reoperations and infections two years […]
FDA clears Orthofix 3D-printed titanium cervical spacer system
Orthofix Medical (NSDQ:OFIX) announced today that it received FDA 510(k) clearance for its Construx Mini Ti spacer system. Lewisville, Texas–based Orthofix also administered the first patient implant of the 3D-printed Construx Mini Ti system, which is designed to enhance anterior cervical discectomy and fusion (ACDF) procedures, according to a news release. The Construx Mini Ti […]
FDA warns on use of certain surgical mesh in breast reconstruction
Two surgical mesh brands used off-label in breast reconstruction surgery have had “significantly higher major complication rates,” according to an FDA analysis. Patients implanted with FlexHD by MTF Biologics and AlloMax by BD had higher rates of explantation, reoperations and infections two years after surgery when compared with patients who received one of two other […]
Second Sight names acting CEO
Second Sight Medical (NSDQ:EYES) announced today that it has named a new acting chief executive officer. Los Angeles-based Second Sight said in a news release that Scott Dunbar has been named by its board of directors to replace Matthew Pfeffer as acting CEO. Under Nasdaq rules, an independent director may temporarily be named acting CEO […]
4 innovative devices delivered through catheters
Physicians use catheters to deploy numerous life-saving devices across the healthcare realm, from cardiovascular to neurovascular. They typically insert the thin, flexible tubes in a process called catheterization to deploy devices such as left ventricular assist devices (LVADs), transcatheter aortic valve replacements (TAVRs) and occluders to stop bleeding. The catheter industry is regularly innovating to […]
8 medical device companies that beat the COVID-19 pandemic and prospered
Some medical device businesses not only survived the COVID-19 pandemic but actually thrived — with many producing the medtech needed to fight the coronavirus’s spread. Medical Design & Outsourcing recently analyzed financials for 20 of the largest medical device businesses in the world. Not only was revenue only slightly down for the 20 during 2020, but it was […]
FDA clears Life Spine Prolift Wedge expandable spacer system
Life Spine announced today that it received FDA clearance for its Prolift Wedge expandable spacer system. The Prolift Wedge expandable interbody spacer system with Osseo-Loc surface technology is a lordotic expandable implant for use in micro-invasive transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) procedures, according to a news release. Get the […]
FDA warns plastic component could break in all of Stryker’s STAR ankles
The FDA today issued a warning regarding the STAR ankle previously made by Stryker (NYSE:SYK) — and the potential for a fracture of the plastic component. According to an FDA news release, there is a higher-than-expected risk of the polyethylene (plastic) component of the device breaking as early as three to four years after implantation […]
10 Minnesota medtech startups you need to know
Medical device startups can use all the help they can get, including from government-sponsored investment funds. In Minnesota, one of the nation’s top three medtech hubs, the state Department of Employment and Economic Development (DEED) has distributed $1.6 million per year since 2019 in innovation grants to tech startups — many of them in the […]
Merck moving to Phase 2 study of drug-eluting implant to prevent HIV infection
Merck (NYSE:MRK) today announced positive results from a Phase 1 study of its subdermal drug-eluting implant for preventing HIV-1 infection. The investigational implant has the potential for extended administration of islatravir for pre-exposure prophylaxis (PrEP) of HIV-1 infection, according to a news release. Get the full story at our sister site, Drug Delivery Business News.