Hologic To Pay $350M For Gynesonics
A company that works to develop minimally invasive solutions for women’s health is being acquired by Hologic. The agreement, which was announced on 14 October, will see Hologic paying $350m for Redwood City, CA-based Gynesonics Inc.
Gynesonics’ flagship product is the Sonata system, which is used for diagnostic intrauterine imaging and transcervical treatment of certain symptomatic uterine fibroids, including those associated with heavy menstrual bleeding. It combines real-time intrauterine ultrasound guidance with targeted radiofrequency ablation in an incisionless procedure.
“Gynesonics’ Sonata System complements our offering and will give GYN surgeons across the globe an expanded range of options to treat women suffering from heavy periods and fibroids,” said Brandon Schnittker, division president of surgical solutions at Hologic. “This acquisition furthers our commitment to providing women with minimally invasive treatment options.”
FDA Approval For Novocure Lung Cancer Treatment
Swiss device firm Novocure has won approval from the US FDA for the Optune Lua, a portable device used alongside chemotherapy drugs to treat adults with metastatic non-small cell lung cancer (mNSCLC) who did not respond to other treatments.
Optune Lua is a portable device that emits electric fields known as tumor treating fields (TTFields), which are delivered through wearable arrays. The fields work against the electrically charged components of dividing cancer cells, leading to cell death. It is used concurrently with PD-1/PD-L1 inhibitors or docetaxel.
In a randomized clinical trial, patients using the Lua saw a three-month extension in their overall survival over those using pharmaceuticals alone. The benefit reached eight months for patients who received Optune Lua and a PD-1/PD-L1 inhibitor.
“The overall survival results we observed with Optune Lua in the LUNAR study mark the first substantial improvement in more than 8 years in this patient population which, when combined with Optune Lua’s lack of systemic toxicity, make this a compelling development for many patients and their physicians who need better treatment options for this advanced disease,” said said Ticiana Leal, director of the thoracic oncology program at the Emory University School of Medicine and primary investigator of the pivotal trial.
CMR Surgical Versius Surgical System Gains US FDA De Novo Approval
CMR Surgical received FDA de novo authorization for its Versius Surgical System on 15 October.
The Versius Surgical System is a robotic-assisted surgical device (RASD) indicated for soft tissue minimal access surgery such as gallbladder removal in adults aged 22 and older. It controls Versius Surgical endoscopic instruments such as rigid endoscopes, scissors, forceps and accessories to manipulate tissue. CMR Surgical says it is the first RASD of its type to reach market via the de novo process.
“The US is a mature market for surgical robots, so it is hard to believe that until today there was little choice when deciding to start a soft tissue robotics program,” said Erik Wilson, division director and vice chair of surgery at the University of Texas McGovern Medical School at Houston. “Versius securing FDA clearance is an important step forward for helping hospitals of any size to be able to offer robotic-assisted surgery.”
IMDRF Adds 15 Affiliate Members
The International Medical Device Regulators Forum has added 15 new affiliate members from Africa, Asia, Latin America and the Middle East over the last year, trade group AdvaMed announced recently. IMDRF members voluntarily convene to harmonize device regulatory requirements from country to country.
The new members are Botswana, Costa Rica, Dominican Republic, El Salvador, Ethiopia, Kenya, India, Jordan, México, Oman, Nigeria, Paraguay, Peru, Tanzania, and Zimbabwe. Together, they have a population of more than 2 billion, or about a quarter of the world’s population.
Affiliate membership is open to regulatory authorities who wish to work with IMDRF, but do not wish to become official observers. Members with the status may attend IMDRF’s open meetings, use IMDRF documents in part or in whole as the basis for their own regulatory framework, and participate in open working groups.
“The IMDRF has the important mission of harmonizing medtech regulations from country to country. This leads to more efficient patient access to medtech innovations globally. The organization has done a great job adding new affiliate members from Latin America, Africa, the Middle East, and India,” said Scott Whitaker, Advamed’s president and CEO.
FDA Issues Draft Guidance On Blood Storage Systems
New draft guidance from the US FDA makes recommendations on the development of blood collection, processing, and storage systems that are intended for the manufacture of blood and blood components for transfusion using the buffy coat (BC) method. Products covered by the document include blood bags with anticoagulant and additive solutions and empty bags for platelet pooling.
American blood processing labs use a two-step technique called the platelet rich plasma (PRP) method to separate blood into its components. In it, blood is first centrifuged at a low speed for separation into red blood cells and PRP. The PRP then goes through a second centrifuge to separate it into platelet and plasma components.
In contrast, the buffy coat method uses a single centrifuge process in which whole blood is rapidly spun to separate it into plasma, red and white blood cells, and other components. Some US establishments want to use the BC method to prepare blood products for transplant. Research has shown that blood products prepared with the two methods are comparable, and logistical advantages of the BC method could result in higher plasma and platelet recovery and increased platelet availability.
Right now, the use of BC in the US has been delayed because no US blood containment devices have been FDA-cleared for use with BC-treated blood products. The guidance document is intended to help manufacturers fill the gap. It makes recommendations on what manufacturers should include in marketing submissions as well as proposed clinical trial benchmarks to demonstrate effectiveness.
The FDA is accepting comments on the document at Regulations.gov.