A merger has been announced between Sandhill Scientific and Medovations, both owned by Diversatek, through which they will operate as a single organization named Diversatek Healthcare. Through the merger, Sandhill's diagnostic solutions for esophageal motility disorders, gastroesophageal reflux disease and anorectal motility disorders will be combined with Medovations' portfolio of endoscopy products.
Reimagine the life science patient experience The life science industry is undergoing rapid transformation, driven by consumer empowerment, clinical innovation and outcomes-driven health care policy. In this changing landscape, medical device and pharmaceutical companies are striving to connect with patients and deliver the best possible experience before, during and after therapy. Learn more.
A mixed shelf offering involving nine unnamed investors has brought in $8.2 million for Novi, Mich.-based Delphinus Medical Technologies, according to a filing with the SEC. The company, which makes the SoftVue whole breast ultrasound system, did not disclose how it intends to use the proceeds and is still looking to raise $16.8 million in the round.
Tissue Regeneration System's 3D technology has been acquired by Johnson & Johnson unit DePuy Synthes in a move that is expected to bolster the company's trauma platform. Using TRS' 3D-printing methods, DePuy will be able to enhance its ability to develop patient-specific, unique mineral-coated bioresorbable implants for promoting bone healing in patients with craniomaxillofacial and orthopedic deformities and injuries.
TypeZero Technologies has signed a nonexclusive agreement giving Cellnovo a commercial license to integrate its artificial pancreas software, inControl AP, into Cellnovo's all-in-one, mobile insulin pump system. The deal, for which terms were undisclosed, allows Cellnovo to globally commercialize a Cellnovo-TypeZero product, with the integrated product expected to be launched next year.
A GlobalData report predicts the European market for pancreatic and biliary stents will reach about $84 million by 2023 with a 4.8% compound annual growth rate because of the development of stenting technology and higher cancer rates. Boston Scientific and Cook Medical are the leading market players.
The STRIVE trial, a longitudinal, prospective, observational study, has been launched by Illumina spinout Grail in hopes of developing and validating a next-generation sequencing-based blood test for detecting early-stage breast cancer. The multicenter study will include up to 120,000 women receiving routine mammograms throughout the Sutter Health system in Northern California and at the Mayo Clinic.
Cardiac Insight has obtained clearance from the FDA for its single-use, leadless, wearable electrocardiogram sensor, Cardeo Solo. The water-resistant, disposable device, which can be worn for up to a week, stores information on patient symptoms and ECG data and allows for real-time analysis of cardiac data with tandem software.
The FDA has granted Halyard Health clearance to market its Coolief cooled radiofrequency thermal treatment for relieving chronic moderate to severe osteoarthritis pain in the knee. The minimally invasive, thermal radiofrequency pain management system safely deactivates sensory nerves that cause pain using water-cooled technology.
The FDA has given Illinois-based Life Spine clearance to market its Plateau-C Ti cervical spacer system, which comes with OSSEO-LOC titanium surface technology to support potential bone growth. The system promotes increased visibility in situ and bone graft containment by providing additional graft windows.
A recall initiated by Medtronic involving nearly 2,000 StrataMR adjustable valves and shunts has been classified by the FDA as Class I. The recall was issued because a design flaw may lead to underdrainage of cerebrospinal fluid, posing the risks of headaches, vomiting, nausea, coma and death.
May 23-24 | Washington, D.C. 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 will explore these issues during this two-day workshop. Learn more.
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