An agreement has been reached by Johnson & Johnson's German device unit, Johnson & Johnson GmbH, to buy Surgical Process Institute, a German software firm that specializes in surgical workflow standardization and digitization in the surgical theater. The acquisition, for which terms were not disclosed, is expected to be completed this quarter.
A round of seed financing pulled in $3.1 million for San Clemente, Calif.-based Spinal Singularity. The money will be used for clinical validation of the company's Connected Catheter, which is designed to last 29 days, reducing urinary tract infections and replacing disposable intermittent catheters in men with chronic lower urinary tract dysfunction.
A round of financing brought in about $2.1 million for Irish medtech company AventaMed, a spin-out from the Cork Institute of Technology's Medic research center, that makes the Solo Tympanostomy Tube Device for simplifying insertion of plastic ear tubes in pediatric patients with ear infections and hearing loss. The proceeds will be used to help the company secure approval from the FDA and enter the US market.
Quest Diagnostics agreed to buy Cleveland Clinic spinoff Cleveland HeartLab, a company that offers biomarker tests for predicting cardiovascular diseases, under an equity deal that is expected to close in the fourth quarter. Quest will also partner with the Cleveland Clinic for diagnostic services and create a national center of excellence in cardiometabolic disorders at Cleveland HeartLab.
A partnership was reached by Insulet and Dexcom to provide users of the Animas insulin pump with a Welcome Program that includes a free Omnipod tubeless insulin delivery system, built-in blood glucose meter and 30 days of supplies, as well as a $200 gift card for the purchase of Dexcom's G5 mobile continuous glucose monitor. The partnership comes after Johnson & Johnson announced its exit from the insulin pump business.
A prolonged slowdown in Puerto Rican medical device manufacturing operations after Hurricane Maria could result in shortages in trauma-based devices, valves, surgical sutures and catheters, among other products, said Greg Crist, a spokesman for AdvaMed. Twenty-three of AdvaMed's members in Puerto Rico are relying on generator power, and "if the situation does not change in the next three to seven weeks, you're going to see drawdowns and eventual shortages," Crist said.
7 keys: Put real-world evidence into action Life sciences organizations need to know how their therapies work in the real world once clinical trials end. And these seven key components to standardizing real-world data and analytics platforms are how they get started. Read the paper, Institutionalizing Real World Evidence.
France's regulatory agency granted Pixium Vision approval to conduct a five-patient feasibility clinical study of the Prima system, a next-generation subretinal wireless implant system intended for the treatment of retinal dystrophies with a focus on advanced atrophic dry age-related macular degeneration. The study will assess the system's tolerance, as well as evoked central visual perception, among patients who lost their sight because of dry AMD, with evaluations at six months and 36 months.
The Halcyon image-guided volumetric intensity modulated radiotherapy cancer treatment system was launched by Varian Medical in the European Union, with the first procedure using the product recorded in Belgium. The system comes with enhancements that improve patient comfort and streamline workflow of the operator, reducing the steps from start to treatment from 30 in legacy machines to nine in the Halycyon system.
Modulus XLIF, a 3D-printed porous titanium implant, was launched by NuVasive for use in extreme lateral interbody fusion procedures. The implant is made with an additive manufacturing technology that allows for reduced stress shielding by creating an architecture that imitates the porosity and stiffness of the natural bone.
European regulators gave Implanet CE mark approval for Jazz Passer, a system intended for use in posterior fixation during spine surgery for treating degenerative scoliosis deformities and trauma pathologies. The system comes with new instruments, including a variation of the company's Jazz Band braid and is compatible with the whole Jazz Platform.
Oct. 25-26, 2017 | San Diego, Calif. This next-level reimbursement workshop was created with the more advanced professional in mind. You'll walk away from this workshop with more insight into the complex and critical nature of coverage issues and policy. Learn more.
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