Three former FDA commissioners are calling on Congress to fully fund the agency’s $60 million fiscal year 2020 budget for using more real-world evidence to evaluate drugs, biologics and devices. Most of that money — $23 million — is earmarked for medical devices. The document is titled “Expanding the Use of RealWorld Evidence in Regulatory […]
These 5 DIY medical devices might surprise you
Big ideas in medical device development can come from regular people driven to solve vexing problems. Here are a handful of folks from outside the medtech industry who decided to create devices to solve their own health troubles or those of others around the world. Read on to see what high school, college and medical […]
BioSig raises nearly $3.3 million for new, non-EP company
Cardiac arrhythmia-detection startup BioSig Technologies (NSDQ:BSGM) has raised $3.26 million for a subsidiary that is developing more applications for its electrogram-evaluation technology. The company attributed the funding round to 17 investors, according to a regulatory filing. It began the offering on August 5 with a goal of raising $3.6 million. BioSig formed NeuroClear Technologies in November […]
Report: 32 new lawsuits filed against Sterigenics in Illinois over ethylene oxide emissions
This article has been updated with comments from one of the plaintiffs’ attorneys. More than 40 lawsuits have been filed against Sterigenics by people who claim that emissions from the company’s Willowbrook, Ill. medical device sterilization plant have adversely affected their or their relatives’ health, according to a report by the Associated Press. Lawyers for the plaintiffs filed 32 […]
Arthrex loses another round in patent spat with Smith & Nephew
Arthrex has lost another battle in a patent dispute with Smith & Nephew’s (NYSE:SNN) ArthroCare. A U.S. Court of Appeals panel today rejected Arthrex’s attempt to overturn a Patent Trial and Appeal Board ruling that two claims of an Arthrex patent on a surgical suture anchor are unpatentable. Smith & Nephew had challenged claims 10 […]
FDA warns Innovative Sterilization Technologies on marketing language
This article has been updated with a statement from Innovative Sterilization Technologies. The FDA has issued a warning letter to Innovative Sterilization Technologies, claiming that the Dayton, Ohio-based company has been marketing its surgical device sterilization trays for non-cleared purposes. Innovative Sterilization Technologies makes the One Tray reusable sealed sterilization container intended to hold reusable medical […]
Ultrasound firm Terason partners with DiA Imaging Analysis
Ultrasound imaging company Terason said today that it has inked a deal with y DiA Imaging Analysis to provide DiA Imaging’s cardiac solutions on Terason’s point-of-care ultrasound devices. The partnership fills a market need for more accurate and objective image analysis for clinicians in hospitals and outpatient settings, that commonly analyze ultrasound images visually, according […]
Delcath Systems raises another $9.5m
Delcath Systems (OTC:DCTH) has closed on a $9.5 million private placement round, bringing the total amount raised since July to $29.5 million. The Queensbury, N.Y.-based company priced the round at $1,000 per unit, with each unit consisting of a preferred convertible share worth 16,667 common shares, at a 6¢ strike price, and a five-year warrant for […]
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 […]
Restoration Robotics lands CE Mark for hair restoration system
Restoration Robotics (NSDQ:HAIR) said it has received CE Mark approval for the sale of the Artas iX system designed forf hair restoration. The CE Mark approval follows the company’s receipt of ISO 13485:2016 certification for Artas iX in January 2019. The Artas iX robotic hair restoration system has a three-camera stereoscopic vision system with 44-micron […]
Department of Justice clears Misonix in China FPCA probe
Misonix (NSDQ:MSON) said last week that the U.S. Department of Justice has dropped its inquiry into the company following a probe of self-reported possible Foreign Corrupt Practices Act violations in China. The Justice Department action, detailed in an August 13, 2019, letter to the company, follows the Securities & Exchange Commission’s June 18, 2019, letter […]