The FDA has issued a warning letter to Conformis (NSDQ:CFMS) about the number of failures in the company’s Wilmington, Mass. vaporized hydrogen peroxide (VHP) system, the company said in a regulatory filing. VHP is used in low-temperature sterilization and is compatible with a wide range of medical instruments and materials, including polypropylene, brass and polyethylene. Unlike ethylene oxide, a […]
Conformis launches next-generation hip system
Conformis (NSDQ:CFMS) has won FDA clearance for its latest 3D-designed Conformis hip system for hip surgeries. The Billerica, Mass.–based company began hip surgeries in July 2018 during a limited launch of its hip system. The latest version of the system, announced yesterday, incorporates design improvements based on surgeon feedback after more than 400 surgeries were completed […]
These 10 medtech companies care a lot about research
These 10 medical device companies spent the largest portion of their budgets on research and development. Here’s a look at what they produced. Each year, Medical Design & Outsourcing compiles a list of the top 100 medical device companies across the globe and ranks the companies based on annual revenue for the most recent fiscal year. We […]
Smith & Nephew taps ex-Roche chief Diggelman for CEO | Personnel Moves, October 21, 2019
Smith & Nephew (NYSE:SNN) today named former Roche (PINK:RHHBY) chief Roland Diggelmann to replace Namal Nawana next month. Nawana, named to succeed Olivier Bohuon last year, is stepping down effective Nov. 1 “to pursue other opportunities outside of the U.K.,” the London-based healthcare giant said. Nawana is slated to stay on until Dec. 31 to […]
Nelipak names Roger Prevot CEO | Personnel Moves, Oct. 16, 2019
Nelipak Corp. said last week that Roger Prevot will take over as CEO, following the retirement of current CEO Michael Kelly. Kelly was in charge when private equity giant Kohlberg bought Nelipak for an undisclosed amount July 2. Kelly is retiring after overseeing the deal and positioning the company for the next phase of its […]
Stryker inks $30m deal with Conformis
UPDATED Oct. 2, 2019, with details on the agreement. Stryker (NYSE:SYK) inked a deal worth up to $30 million for the customized instrumentation technology developed by Conformis (NSDQ:CFMS). The deal calls for Stryker to pay $14 million up front for the Conformis patient-specific instrumentation, which uses CT scans to create customized, single-use instrumentation for knee replacement […]
Appeals court tosses two ConforMIS patents despite settlement with Smith & Nephew
A federal appeals court has upheld U.S. Patent Trial and Appeal Board decisions invalidating two ConforMIS (NSDQ:CFMS) patents for patient-specific knee implants, even though ConforMIS and Smith & Nephew (NYSE:SNN) settled their dispute last year for $10.5 million. Bedford, Mass.-based ConforMIS sued the British healthcare giant in 2016 in the U.S. District Court for Massachusetts, alleging infringement […]
ConforMIS sues Zimmer Biomet for alleged patent infringement
ConforMIS (NSDQ:CFMS) has sued Zimmer Biomet (NYSE:ZBH) alleging infringement of four different patents for personalized joint replacement surgery. In the lawsuit filed last week in U.S. District Court in Delaware, ConforMIS claims that Zimmer Biomet has infringed its patents for personalized knee and hip replacement surgery and for shoulder arthroplasty. Bedford, Mass.-based ConforMIS is targeting Zimmer […]
ConforMIS beats The Street with Q2 results
ConforMIS (NSDQ:CFMS) posted second-quarter 2019 results that beat the consensus on Wall Street by 1¢. The Billerica, Mass.-based company reported a loss of -$6.7 million or -11¢ per share on sales of $9.6 million for the three months ended June 30, 2019. The company halved its quarterly loss for a bottom-line gain of 48% on sales […]
ConforMIS lines up $33m financing
ConforMIS (NSDQ:CFMS) said yesterday that it lined up $33 million in financing for its customized joint replacement devices. Innovatus Capital Partners and East West Bank put up $30 million in debt financing and Innovatus took out a $3 million equity position in Billerica, Mass.-based ConforMIS. The proceeds are earmarked for paying down a $15 million term […]
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 […]
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