ICU Medical (NSDQ:ICUI) said today it inked a long-term distribution deal with B. Braun Medical for ICU’s SwabCap disinfecting cap for needlefree connectors for select countries outside the U.S. San Clemente, Calif.-based ICU Medical’s SwabCap is a disposable cap designed for disinfecting needlefree connectors with 70% isopropyl alcohol when attaching them to an intravenous catheter. “We look […]
Contract Manufacturing
Olympus updates reprocessing instructions for Duodenoscopes
The FDA yesterday released updated reprocessing instructions it received from Olympus (TYO:7733) in relation to its TJF-160F and TJF-160VF duodenoscopes. Olympus has been working on refining its reprocessing instructions since March last year, the FDA said, and only in January did the agency clear the updated reprocessing models as adequate. The updated reprocessing instructions include a […]
FDA warns SureTek on sterilization, QC issues
The FDA issued a warning letter it sent to single use device reprocessor SureTek Medical earlier this month over issues with the company’s cleaning and validation processes. The letter was in response to an inspection performed between October and November last year, which SureTek Medical responded to 3 times to address the federal watchdog’s concerns […]
Analyst: Long-term upside for contract manufacturers despite near-term challenges
While U.S. medical device contract manufacturers may be facing choppy waters right now, there’s smooth sailing ahead in the long term, according to a new report from Standard & Poor’s Ratings Services. A key factor holding back industry growth, S&P reports, are the industry-wide cost-containment efforts associated with health care reform. Health care spending growth […]
Cantel Medical closes $13.5m buy of NAMSA’s sterility assurance biz
Cantel Medical (NYSE:CMN) said today it closed its $13.5 million buy of North American Science Associates sterility assurance business, which Cantel said it plans to fold into its Crosstex division. The NAMSA operation, which posted sales of $5.7 million last year, makes biological and chemical indicators designed to monitor the effectiveness of sterilization procedures. Little Falls, […]
Cantel Medical buys NAMSA’s sterility assurance biz for $14m
Cantel Medical (NYSE:CMN) and North American Science Associates said they agreed to a $13.5 million cash deal for NAMSA’s sterility assurance business, which Cantel said it plans to fold into its Crosstex division. The NAMSA operation, which posted sales of %5.7 million last year, makes biological and chemical indicators designed to monitor the effectiveness of sterilization procedures. […]
Stericycle agrees to $29m settlement in False Claims Act case
A federal judge in Illinois yesterday approved a settlement agreement between Stericycle (NSDQ:SRCL) and the plaintiff in a whistleblower lawsuit accusing the medical waste disposal company of overbilling federal and state governments to the tune of some $13.6 million. Jennifer Perez, a government customer relations specialist at Lake Forest, Ill.-based Stericycle from 2004 until March 2008, filed a qui tam lawsuit […]
FDA to offer webinar on new final guidance on sterility
The FDA said yesterday it will host a webinar covering newly released guidance concerning sterilization. The federal watchdog yesterday issued a final guidance on sterilization, outlining adequate sterilization methods for sterile-labeled 510(k) devices and the appropriate documentation necessary for the premarket review of novel sterilization processes. The Agency said its final guidance also included details […]
Steris gains on post-Synergy merger outlook
Steris (NYSE:STE) shares are up nearly 8% since the company last week issued its 1st post-merger guidance since its $2 billion merger with the U.K.’s Synergy Health, as investors reacted to a top-line growth forecast of 21% to 22% for fiscal 2016. Mentor, Ohio-based Steris closed the Synergy merger Nov. 2 in a so-called inversion deal, in which it re-incorporated as a […]
Pritzker Group’s Technimark buys Ci Medical
Pritzker Group Private Capital subsidiary Technimark said today that it acquired specialty medical component maker Ci Medical Technologies from Altaris Capital Partners for an undisclosed amount. Latrobe, Pa.-based Ci Medical specializes in product development, scientific molding, contract manufacturing, assembly, packaging and logistics. Asheboro, N.C.-based Technimark said the deal expands both companies’ footprints. Ci Medical employs more […]
Proven Process to develop cell implant device for Giner
Proven Process Medical Devices said yesterday it signed on to develop and manufacture a cell implant device for Giner used to administer cell therapies for indications such as liver failure, Parkinson’s disease, parathyroid disease, pancreatectomy and Type 1 diabetes. Giner is developing a miniaturized implantable electrochemical oxygen generator to continuously supply oxygen to islets or cells […]