Elucent Medical wins FDA nod for EnVisio breast surgery navigation device

Elucent Medical

Elucent Medical said today that it won FDA 510(k) clearance for its EnVisio surgical navigation system.

The Eden Prairie, Minn.-based company said that the EnVisio navigation system is designed for use in conjunction with the company’s SmartClip soft tissue marker during breast cancer procedures.

The SmartClip soft tissue marker is an alternative to hook-wire localization procedures used to identify malignant tissue for removal, the company said. When used with the Envisio system allows physicians to mark difficult lesions and navigate distances, depths and directions in real-time 3D during breast cancer procedures.

“Elucent Medical is offering a cost-effective solution that addresses a key challenge for breast surgeons: how to easily find the location of a malignant biopsy during surgery, especially in tissue that lacks anatomical landmarks. We developed a system designed by surgeons to be intuitive, efficient, and precise, eliminating the need for a localization procedure. We believe this innovation has the potential to improve cosmetic and clinical outcomes, with other possible applications for lymph and thoracic surgeries,” co-founder Dr. Lee Wilke said in a press release.

“Our vision is to disrupt the standard of care for women who receive localization prior to their lumpectomy as part of their breast cancer treatment. Today we take a significant step toward achieving this goal. The EnVisio Navigation System and SmartClip Soft Tissue Markers will provide patients and surgeons with a wire-free, minimally invasive alternative for pre-surgical planning and navigation throughout surgery,” co-founder and CEO Laura King said in a prepared statement.

Australia’s TGA considering, but not yet implementing, textured breast implant ban

Australia's TGA

Australia’s TGA said yesterday that it is seeking new data from suppliers of textured breast implants, which have been linked to a rare immune-system cancer, before making a decision on whether or not to suspend or cancel those products from its Register of Therapeutic Goods.

The regulatory body gave suppliers of the devices 10 working days to respond to the requests for more information, including dates they began to supply the devices and samples of the implants, according to a TGA release.

The decision comes after the convening of a breast implant expert panel on April 8, following recent decisions made in Canada and France to remove select implants from the market.

The implants have been linked to breast implant-associated anapestic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma.

The TGA said that the panel it convened discussed current data on the implants associated with BIA-ALCL and identified gap in the data that affected estimation of the true rate of the cancer in the country.

The regulatory body said that as of April 8, it has received 76 reports of BIA-ALCL in Australian women. The agency said that there are approximately 13,000 to 17,000 breast implant procedures performed in the country each year.

The panel also discussed the benefits of textured implants, particularly for reconstructive new surgery, and made suggestions including a need to update the TGA’s website with risks and benefits and to better encourage use of the Australian Breast Device Registry.

The TGA said that like the FDA and many other regulatory bodies, it has been monitoring BIA-ALCL cases since 2011, adding that the first adverse event report it received related to the cancer came in in 2009.

The agency said that textured implants of varying roughness are used in 82% of operations in the country.

Last month, a panel of experts convened by the FDA said that there’s not enough data to pull textured breast implants from the market over concerns that they may be linked to a type of immune system cancer.

Varian Medical joins embolic therapy tech dev ABK Biomedical’s $30m Series B

Varian Medical, ABK Biomedical

Varian Medical (NYSE:VAR) has joined a $30 million Series B round of financing for embolic therapy tech developer ABK Biomedical.

Palo Alto, Calif.-based Varian Medical Systems led the round alongside F-Prime Capital, Halifax, Nova Scotia-based ABK Biomedical said.

“ABK has a unique approach to address a large unmet need for patients with non-resectable liver tumors. This technology is aligned with our goal of delivering innovative solutions in cancer care,” Varian strategy & biz dev VP Gregory Sorensen said in a press release.

“We are impressed with the ABK Biomedical team and believe the company has an outstanding product platform with the potential to make a significant impact on the lives of patients with malignant liver tumors,” F-Prime Capital partner Dr. Ketan Patel said in a prepared release.

Funds from the round will support continued development of the Eye90 microspheres, designed for transarterial radiation therapy and intended to treat liver tumors, and its Easi-Vue microspheres, intended for the bland embolic treatment of hypervascular tumors.

ABK Biomedical said that funds will support R&D, manufacturing and a clinical development program intended to support regulatory submission for both the Eye90 and Easi-Vue, the company said.

“Our thought-leading physician partners and advisors see tremendous opportunities to improve procedural and oncologic outcomes for patients suffering from non-resectable liver tumors. The ABK platform aims to deliver key technical benefits over existing yttrium-90 (Y-90) microspheres technologies for improved procedural and clinical outcomes. ABK combines the benefits of advanced imaging and dosimetry analysis with the empirically proven clinical benefits of Y-90 transarterial radiation therapy,” ABK Biomedical prez & CEO Mike Mangano said in a prepared statement.

AirXpanders touts study results

AirXpanders (ASX:AXP) said that a retrospective clinical study has concluded that the use of its AeroForm tissue expanders may be associated with reduced infection rates, less medical treatment and lower costs for patients and health systems.

The Palo Alto-based company makes the AeroForm tissue expander for post-mastectomy breast reconstruction. The device is designed to expand and stretch the skin and underlying muscle prior to a permanent breast implant using small amounts of CO2 up to three times a day.

Get the full story on our sister site, Medical Design & Outsourcing.

FDA wants to update mammography standards

The FDA today issued a proposed rule that would modernize mammography quality standards and require mammography facilities to provide more information to patients and healthcare providers.

The proposed rule would be the first update in 20 years, amending regulations issued under the Mammography Quality Standards Act of 1992, which authorizes FDA oversight over mammography facilities, including their accreditation, certification, annual inspections and enforcement of standards. The new proposal could help patients and providers make more informed decisions regarding care, and boost the FDA’s regulatory power over the safety and quality of mammography services, the agency said.

The proposed amendments include:

  • Adding specific language about breast density to the mammography results summary letter provided to patients and to the medical report sent to providers.  Mammograms of breasts with a higher proportion of dense fibroglandular tissue compared to fatty tissue can be difficult to interpret because the dense tissue can obscure signs of breast cancer, lower the sensitivity of the image and increase the risk of developing breast cancer.
  • Codifying three more categories for mammogram assessment, including one titled “known biopsy-proven malignancy,” which would help identify for health care professionals cases in which cancer that is being evaluated by mammography for therapy has already been identified.
  • Adding more detailed information about the mammography facility to patient summaries and medical reports for caregivers to aid in post-exam communications.

Proposed changes to boost the FDA’s enforcement powers include:

  • Expressly stating that the FDA can directly notify patients and their health care professionals, should facilities be unwilling or unable to do so, that mammography at a facility did not meet quality standards and that reevaluation or repeat of the mammogram at another certified facility may be needed.
  • Requiring facilities to use only FDA-approved or -cleared digital accessory components for mammography, or that facilities use components that otherwise meet the requirements under the rule.
  • Strengthening record-keeping requirements to minimize information loss and improve access to and transfer of patient mammography records.

“As part of our overall commitment to protecting the health of women, we’re proposing new policies to modernize our oversight of mammography services, by capitalizing on a number of important advances in mammography, like the increased use of 3-D digital screening tools and the need for more uniform breast density reporting,” said FDA commissioner Dr. Scott Gottlieb in a prepared statement. “We’re committed to making sure patients have access to high-quality mammography. Today’s proposed rule would help to ensure patients continue to benefit from advances in new tools and robust oversight of this field.”

According to the National Cancer Institute (NCI), approximately 12.4% of women will be diagnosed with breast cancer at some point during their lifetime. NCI estimates that, in 2018, more than 260,000 women were diagnosed with breast cancer and more than 40,920 women died of the disease. Aside from skin cancer, breast cancer is the most common cancer among women and the second leading cause of death. Mammography can also be an important tool in detecting male breast cancers. According to the NCI, breast cancer may occur in men at any age, but usually occurs in men between 60-70 years of age.

“The FDA is committed to advancing efforts that improve the health of women,” said FDA principal deputy commissioner Dr. Amy Abernethy. “Given that more than half of women over the age of 40 in the U.S. have dense breasts, helping to ensure patient access to information about the impact that breast density and other factors can have on the risk for developing breast cancer is an important part of a comprehensive breast health strategy.”

The proposed rule may be found here and is available for public comment for 90 days from publication.

The post FDA wants to update mammography standards appeared first on MassDevice.

FDA Panel: Too early to pull textured breast implants over cancer risk, need more data


A panel of experts convened by the FDA yesterday said that there’s not enough data to pull textured breast implants from the market over concerns that they may be linked to a type of immune system cancer, according to an AP News report.

The recommendation comes from the first day of a two-day panel meeting discussing the risks associated with breast implant devices, reviewing current study data and exploring how to best track and treat the cancer, and other issues, the devices have been tied to.

The FDA only began reporting on the cancer, known as breast implant-associated anaplastic large cell lymphoma, and its link to implants in 2011. Last month, the federal watchdog said it has received 457 unique reports of the cancer, with 246 new adverse event reports related to it since 2017.

Estimates of the frequency of the disease range greatly, from one in 3,000 to one in 30,000, according to the AP News report. The disease has also been reported to the FDA by patients with smooth implants, and other research has indicated that silicone that leaks from the implant could possibly trigger or exacerbate immune system disorders.

Despite the increased visibility of the cancer and its link to implants, the panel did not recommend any immediate restrictions on the devices, according to the report. The majority of the 19 panelists said that it was too soon to pull the products from the shelves.

Consumer advocates, and the panel’s consumer representative, did not agree, according to AP News. The consumer rep said that many women who receive the implants do so as part of reconstructive surgery following breast cancer surgery, and the risk of subjecting those women to a second cancer was enough to justify their commercial removal.

Panelists were receptive to patient advocates’ calls for more standardized risk disclosures and informed consent for women considering the devices, according to the report.

The panel is meeting again today, continuing to explore how to diagnose and treat the breast implant-linked cancer as well as other concerns related to the devices.

Though they are meeting for another day, the panel is still not expected to recommend a ban on textured implants, according to SVBLeerink analyst Richard Newitter, which is good news for manufacturers of the devices, including Sientra(NSDQ:SIEN) and Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide.

Both Sientra and Mentor received warning letters last week from the FDA over failures to conduct appropriate post-approval studies of the devices.

“It seems more likely that the panel will focus its “actionable” recommendations on: (a) improved data collection around implants going into patients (at the time of primary & revision surgeries,) (b) stepped up infrastructure/resources to facilitate (possible mandatory) registry participation, (c) more compliant post-surgery surveillance on the part of industry, and (d) a more rigorous approach to informed consent,” Leerink analyst Newitter said in a letter to investors.

The post FDA Panel: Too early to pull textured breast implants over cancer risk, need more data appeared first on MassDevice.

Elekta wins Health Canada approval for Elekta Unity MR radiation therapy system


Elekta (STO:EKTA B) said today that it won Health Canada approval for its Elekta Unity magnetic resonance radiation therapy system.

The Elekta Unity system consists of a high-field 1.5 Tesla MRI scanner and a linear accelerator alongside integrated real-time dose planning software for target monitoring, the Stockholm-based company said.

Elekta added that its Elekta Unity device has the ability to reshape doses based on daily changes in shape, size and the position of the tumor and surrounding healthy anatomy.

“We are pleased to have achieved this important milestone toward making Elekta Unity available in Canada and expect that this important new treatment option will become available to patients later this year, subsequent to receiving a service license from the Canadian Nuclear Safety Commission. Researchers and clinicians from the Odette Cancer Centre at Sunnybrook Health Sciences Centre and Princess Margaret Cancer Centre have played critical roles in developing and evaluating this transformative technology, and we look forward to the day when their patients and other Canadian cancer patients will have access to this transformative approach to radiation therapy,” prez & CEO Richard Hausmann said in a press release.

Last July, Elekta said that it acquired Canadian quality assurance company Acumyn for an undisclosed amount.

The post Elekta wins Health Canada approval for Elekta Unity MR radiation therapy system appeared first on MassDevice.

Novocure launches pivotal ovarian cancer trial

NovocureNovocure (NSDQ:NVCR) said today that it kicked off a Phase 3 pivotal trial testing its Tumor Treating Fields therapy combined with paclitaxel in people with recurrent, platinum-resistant ovarian cancer.

The 540-patient trial has a primary endpoint of overall survival, with secondary endpoints that include progression-free survival, objective response rate, severity and frequency of adverse events and quality of life.

Get the full story at our sister site, Drug Delivery Business News.

The post Novocure launches pivotal ovarian cancer trial appeared first on MassDevice.

FDA ramps up scrutiny of materials in medical devices

(Image by Michael Longmire on Unsplash)

The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances.

It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts to regulate the medical device industry. In the past year, Netflix’s documentary “The Bleeding Edge” and the International Consortium of Investigative Journalists’ “The Implant Files” series ripped the agency and the industry over patient injuries attributed to faulty devices. The FDA has been particularly faulted for its 510(k) clearance pathway, under which it allows devices that are similar to previously approved technology to undergo a less strenuous review before they can be sold.

Get the full story on our sister site, Medical Design & Outsourcing.

The post FDA ramps up scrutiny of materials in medical devices appeared first on MassDevice.

Onkos Surgical to use Promimic’s nano-thin HA coating

Onkos Surgical ProminicOnkos Surgical, a surgical oncology device developer, said today that it is working with Promimic AB to commercialize Promimic’s nano-thin hydroxyapatite coating technology for use on limb salvage surgery implants.

Hydroxyapatite (HA) is a major component of normal bone and teeth that is already used as a coating on orthopedic implants to promote fixation and bone in-growth. Onkos is developing 3D-printed implants with novel porous structures to facilitate hard and soft tissue attachment. Promimic’s HAnano Surface — applied in a three-step process that creates a nano-thin HA coating — doesn’t block tiny porous structures.

Get the full story on our sister site Medical Design & Outsourcing.

The post Onkos Surgical to use Promimic’s nano-thin HA coating appeared first on MassDevice.