Analogic escapes Labor Dept. suit over alleged pay discrimination

A U.S. Labor Dept. judge last week dismissed a suit the agency brought against Analogic over alleged pay discrimination.

The Labor Dept. sued Analogic in October 2016, alleging that it paid female assembly workers at its Peabody, Mass., headquarters less than their male counterparts after a compliance review by its Office of Federal Contract Compliance Programs.

In a March 22 decision, Administrative Law Judge Colleen Geraghty dismissed the case, ruling that the OFCCP failed to prove that the alleged discrimination took place.

The office “failed to identify the employment practice causing the alleged pay disparity and Analogic successfully challenged the methodology and findings of OFCCP’s statistical evidence,” Geraghty wrote, noting the company’s successful challenge to an OFCCP expert’s statistical analysis with its own review of the numbers.

In June 2018 Altaris Capital Partners closed a $1.1 billion buyout of Analogic after the imaging device maker’s prolonged search for a suitor.

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LivaNova’s CMS vagus nerve depression device trial must include sham arm

A new U.S. Centers for Medicare & Medicaid Services trial of LivaNova‘s (NSDQ:LIVN) Vagus Nerve Stimulation Therapy system intended to treat treatment-resistant depression will require a sham-control arm, doubling the subject population LivaNova originally expected.

The trial, which the London-based company won clearance from CMS for last month, will allow coverage for the VNS devices through a Coverage with Evidence Development framework.

As revealed last month, the trial will be double-blinded, randomized and feature a follow-up of at least one year, the company said.

New data, revealed in a posting on Clinicaltrials.gov, indicate that the trial will seek 1,000 subjects with an estimated start date of this July. LivaNova said last month that it only planned to include 500 subjects in the trial of the device.

All subjects in the trial will be implanted with the VNS system, though subjects in the sham-control arm will not have the device activated for the first 12 months. After the initial trial, patients in the sham arm will be allowed to join the open-label, prospective and longitudinal portion of the study where they will tracked out to five years.

The primary endpoint of the trial will be mainly monitored through scoring on the Montgomery Åsberg Depression Rating Scale, as well as disability assessments, adverse event monitoring and a selection of other physical and mental health assessment criteria.

Last November, CMS proposed a launch of a clinical trial of the VNS system to explore its ability to treat Treatment-Resistant Depression.

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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.

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3m settles dental crown case for $33m

3M Cos. (NYSE:MMM) agreed to settle a proposed class-action lawsuit brought over alleged defects in its Lava Ultimate dental crown product.

The lawsuit, filed in May 2016 in the U.S. District Court for Minnesota by 39 dentists who used the Lava Ultimate crowns, alleged that they failed at rates that were “orders of magnitude higher than those seen in any other crown material.” More than 1 million Lava Ultimate crowns were sold before 3M pulled the crown indication from the market in June 2015, according to court documents.

“3M represented that its Lava Ultimate restorative product provided dentists and patients with a crown material that had a combination of aesthetics and durability that had previously been unavailable in restorations that were created ‘chairside’ – i.e., at the dentist’s office – during a single visit,” the suit alleged. “The shockingly high failure rates were due to an inherent defect in Lava Ultimate, which made the product inappropriate for the uses for which 3M had previously represented – in particular, Lava Ultimate’s use in dental crowns. All Lava Ultimate crowns contain this inherent defect.”

In March 2018 Judge Donovan Frank tossed claims brought under statutes in various states and struck the plaintiffs’ bid for punitive damages, but allowed other claims to be amended. Although the plaintiffs were seeking to amend the claims Donovan dismissed without prejudice and the case was in discovery, the parties agreed to hire retired Magistrate Judge Arthur Boylan as an outside mediator.

After “rigorous negotiations” over the course of five sessions produced a settlement agreement, earlier this week the plaintiffs asked Frank to approve a deal that would require 3m to create a $32.5 million settlement fund for dentists who experienced at least one de-bonding before June 15, 2020, according to the documents.

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10 women in medtech manufacturing you should know

Women account for nearly one-third of employees in the manufacturing industry, where men have historically held the majority of jobs, according to the U.S. Census Bureau.

The situation includes manufacturers and other outsourcers serving the medical device space.

The lack of diversity is even more apparent farther up the corporate leadership ladder. According to a report from the Centers for American Progress, women hold 52% of professional jobs in the U.S., but only 14.6% of CEOs are women.

The Equal Employment Opportunity Commission also reports that only a fifth of executives, senior officers and managers in the U.S. high-tech industries are women.

To close out Women’s History Month this year, here are 10 women in manufacturing you should know.

Next >>

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DarioHealth, Glytec ink joint marketing deal

DarioHealth (NSDQ:DRIO) said today it inked a joint marketing agreement with Glytec through which DarioHealth’s smart glucose meter will be able to transmit information to Glytec’s Glucommander Outpatient software.

Israel-based DarioHealth said that blood glucose data from its Dario Blood Glucose Monitoring System will now be imported into the Glucommander Outpatient for use in conjunction with other clinical data to create personalized insulin dose recommendations.

Read the whole story on our sister site, Drug Delivery Business News

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CMS touts ‘more flexibility’ in new TAVR coverage requirements

The Centers for Medicare and Medicaid Services have proposed new policy that could expand the use of transcatheter aortic valve replacement procedures, touting that it may provide more flexibility for starting and maintaining TAVR programs.

The original National Coverage Determination for TAVR procedures was cleared in 2012, when the technology and associated procedure was still new. The new policy from CMS looks to update requirements based on new information about the safety and viability of the procedures.

The new proposal, released yesterday, would reduce the number of cardiac surgeons required to independently examine and evaluate patient suitability for open aortic valve replacement surgery or TAVR from two to one.

“We believe this modification is appropriate given the advancements and progress made since 2012 as TAVR becomes more widely performed,” CMS wrote in its proposal.

Volume requirements for existing TAVR programs at hospitals looking to receive CMS reimbursement were raised slightly, according to the new proposal. Previously, hospitals were only required to perform 20 aortic valve replacements per year or 40 per two years – that requirement has been more than doubled to either 50 AVRs per year or 100 AVRs per two years.

For new programs looking to begin TAVR programs, the volume requirements stayed mostly the same, but language was shifted from 50 total AVRs per year to 50 open heart surgeries in the year prior to the program launch and at least 20 aortic valve related procedures in the two years prior to launch.

“When reassessing this requirement, CMS endeavored to balance ensuring hospitals have the experience and capabilities to handle complex structural heart disease cases while limiting the burden and barriers unnecessary requirements may have on both hospitals and patients flexibility. Therefore CMS proposes to maintain the annual volume of cases (≥ 50) in the previous year prior to TAVR but have provided flexibility on how that is met,” CMS wrote in its proposal.

In a press release, CMS said it met with “numerous stakeholders” as it sought new requirements for providers to perform a certain volume of heart procedures. The agency said that the volume procedures are included “given the link between heart procedure volume and patient outcomes in the medical literature and the risks from receiving care in low-volume settings.”

CMS added that it believes the new decisions will provide “more flexibility” in how providers meet those requirements, and that it reflects the “latest evidence on volume and outcomes.”

“CMS must continually refine our policies and requirements in light of emerging evidence. Today’s decision updates the requirements for hospitals and physicians to perform TAVR to ensure these requirements are in line with the latest research on patient outcomes, in order to broaden access to care while safeguarding quality and safety for Medicare beneficiaries,” CMS Administrator Seema Verma said in a press release.

The agency also said it is looking to gather more information about metrics other than volume that could be used to asses quality and safety, and said it is “specifically proposing a question regarding the relationship between other metrics and patient health outcomes, which could inform a future change to replace the volume criteria with a different metric.”

Earlier this month, results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) TAVR systems exploring their use in low-risk patients indicated that the devices were as safe as open surgery, paving the way for possible new indications for TAVR technology.

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