Johnson & Johnson is progressing as planned six months after implementing a restructuring process for its orthopedics, surgery and cardiovascular segments, company CEO Alex Gorsky said at an earnings call in which the company reported global device sales of $6.4 billion during the second quarter, up 0.8% from a year earlier. Gorsky added that in considering merger and acquisition opportunities, the company will be "very disciplined" and "very decisive."
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A direct offering of 3,468 shares of Series B convertible preferred stock has brought in $3.5 million for Eden Prairie, Minn.-based Sunshine Heart, which makes the C-Pulse system for left ventricular load reduction using intra-aortic balloon counter-pulsation. The proceeds will be used for general corporate functions and as working capital.
A round of equity financing has brought in $1 million for El Dorado Hills, Calif.-based Consensus Orthopedics, bringing the company closer to its $4 million goal, according to a filing with the SEC. The company did not disclose how it will use the proceeds.
Bovie Medical's J-Plasma product line will be added to Hologic's gynecological and gynecological/oncological surgery business across three regions in the US under a sales channel partnership agreement. The companies have an option to extend the initial six-month deal into a global distribution agreement involving the full surgical sales force of Hologic.
A deal has been reached between Johnson & Johnson and Belgium-based 3D printing provider Materialise to create personalized titanium 3D craniofacial implants for patients with disorders of the face and skull; terms were undisclosed. Materialise will facilitate 3D printing of the Trumatch line of implants from J&J's DePuy Synthes unit.
Varian Medical Systems' Imaging Components business will be named Varex Imaging upon completion of the division's spinoff by year's end. Sunny Sanyal, president of the Imaging Components unit, will serve as CEO at Varex, which will offer software, components and services for X-ray systems.
The FDA has given LifeBond an investigational device exemption to conduct a study of its LifeSeal Surgical Sealant Kit, which is designed for staple-line leakage reduction in gastrointestinal resection procedures.
A study in Anticancer Research: International Journal of Cancer Research and Treatment showed positive results for Accuray's TomoTherapy system. Use of the system in treating 111 women with once-daily accelerated partial-breast irradiation showed no cancer recurrence after a median of 34 months and resulted in lower toxicity, better cosmetic outcomes and minimal side effects.
The RELIEVA SCOUT Multi-Sinus Dilation System has been launched by Johnson & Johnson subsidiary Acclarent for use in treating patients with chronic sinusitis. The sinuplasty device widens a patient's sinus opening using a flexible balloon.
An FDA panel has voted in favor of approving Dexcom's G5 Mobile Continuous Glucose Monitoring System for use as a replacement for finger-stick testing in patients with diabetes. The panel found that the device, which is currently an adjunct to the method, is safe and effective, and its benefits outweigh the risks of use.
Oct. 5-6 | South San Francisco, Calif. How do you implement and measure the effectiveness of a complaint-handling system covering a diverse set of possible products and problems? How are complaint files managed across multiple domestic and international facilities? When do complaints rise to the level of MDRs, and how do you handle recalls? What are the current FDA enforcement trends in these areas? Industry experts and FDA staff (invited) will explore these issues during this day-and-a-half workshop. Learn more.
Oct. 31-Nov. 1 | Washington, D.C. FDA (invited) and industry experts are coming together to teach you the basics of 510(k) submissions. You'll learn the FDA's updates to the 510(k) process, considerations for determining a product's regulatory route to market, factors to consider when planning and assembling a 510(k) submission, and tips and hints on interacting with the FDA during the 510(k) review process. Learn more.