WHO delivers insulin pens to Ukraine hospitals with support from Novo Nordisk

[Image from WHO]The World Health Organization (WHO) announced that it delivered more than 26 metric tonnes of insulin pens to Ukraine.

WHO distributed approximately 57,320 pounds of insulin pens (more than 370,000 total pens) to hospitals throughout Ukraine. It represents part of an effort to help those with diabetes in the country during the ongoing humanitarian crisis.

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Another C-level executive leaves Dentsply Sirona

Dentsply Sirona’s outgoing chief commercial officer Walter Petersohn [Image courtesy of Dentsply Sirona]Dentsply Sirona (Nasdaq:XRAY) announced that SVP and chief commercial officer Walter Petersohn is leaving the company.

Petersohn’s departure comes among a slew of exits as Dentsply handles an internal investigation into its financial practices. The Charlotte, North Carolina–based dental products and technologies company is investigating its use of incentives to sell products to distributors during the third and fourth quarters of 2021. It is looking into whether the incentives and sales impact were adequately accounted for and disclosed in SEC filings.

The board’s audit committee is also evaluating whether present and former members of the senior management used the incentives and other actions to achieve executive compensation targets.

Last week, the company appointed former BD executive Simon Campion as CEO. This came after John Groetelaars,…

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DermaSensor appoints trio of new executives

[Image from DermaSensor]Skin cancer detection technology developer DermaSensor announced that it appointed three new members to its leadership team.

Miami-based DermaSensor named Larry Anderson as its new chief commercial officer. Dr. Vivien Nguyen also joins as director of medical affairs, while the company promoted Ryan Freiden to COO.

Anderson previously served as VP of sales for Acessa Health, which Hologic acquired. He also held roles at Ethicon, Interlace Medical, Hologic and BG Medical.

“It gives me great pleasure to introduce Larry Anderson as our chief commercial officer,” DermaSensor CEO Cody Simmons said in a news release. “Larry has extensive commercial experience in the medical device field with a strong track record of successfully building teams and launching new technologies.”

Nguyen joins with nearly a decade of experience in medical devices and pharmaceuticals. She held roles at Incyte, Novartis, Suneva Medical and…

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Senseonics CFO is leaving

Senseonics (NYSE:SENS) announced that its chief financial officer, Nick Tressler, is transitioning from his position.

Tressler’s transition is effective as of yesterday, Sept. 1, 2022. Senseonics selected VP of Finance, Rick Sullivan, to succeed Tressler as CFO.

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Philips, DOJ settle for $24.8M over Respironics kickback allegations

Philips (NYSE:PHG) today agreed to pay more than $24 million to resolve False Claims Act allegations revolving around kickbacks.

The U.S. Department of Justice (DOJ) alleged that Philips RS North America (formerly Respironics) misled federal healthcare programs by paying kickbacks to durable medical equipment (DME) suppliers. Affected programs included Medicare, Medicaid and TRICARE, the healthcare program for active military and their families.

According to a DOJ release, the settlement resolves allegations that Respironics caused DME suppliers to submit false claims for ventilators, oxygen concentrators, CPAP and BiPAP machines, and other respiratory-related medical equipment because Respironics provided illegal inducements to the DME suppliers. Respironics allegedly gave the DME suppliers data free of charge that could assist in marketing to physicians.

“Paying illegal remuneration to induce patient referrals undermines the integrity of our nation’s h…

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Illumina clears antitrust hurdle related to merger with Grail

Illumina (Nasdaq:ILMN) announced today that an administrative law judge in the U.S. has rejected the Federal Trade Commission’s argument that the company’s $8 billion acquisition of Grail was anti-competitive.

More than a year after the deal closed, Illumina is still keeping Grail operating as a separate internal entity under a European Commission order. The EU investigation continues, with the company setting aside $609 million in legal contingencies during its second quarter in anticipation of a potential fine.

For now, Illumina has scored a legal win in the U.S. The FTC, like its European counterparts, had argued that the merger could hurt competition and innovation around multi-cancer early detection tests.

“Reuniting Illumina and Grail will transform the detection and treatment of cancer by facilitating widespread, affordable access to Grail’s life-saving Galleri test. This decision is a step toward making that vision a reali…

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Ibex reports positive outcomes for AI-based breast cancer diagnostic

Ibex Medical Analytics announced today that a study of its Galen Breast diagnostic solution delivered positive outcomes.

Tel Aviv, Israel-based Ibex designed its Galen platform to support pathologists in diagnosing breast, prostate, and gastric biopsies.

Galen uses AI and machine learning technology based on hundreds of thousands of image samples scanned from biopsy slides through digital pathology.

The AI technology provides accuracy, speed and objectivity, Ibex said in a news release. It aims to improve the quality of diagnosis, user experience, operational efficiency and patient outcomes.

Galen Breast, which holds CE mark approval, is generally available to laboratories and hospitals across Europe.

In a blinded, multi-site clinical study in France and Maccabi Healthcare Services in Israel, Galen Breast produced strong outcomes. The study evaluated the performance of pathologists who used Ibex AI for diagnosing breast biopsies. It compare…

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Stryker launches new hip fracture nailing system

[Image from Stryker]Stryker (NYSE:SYK) announced today that it launched the Gamma4 next-generation intramedullary nailing system.

Kalamazoo, Michigan-based Stryker designed its Gamma4 system to treat stable and unstable fractures. It also holds indication for the stabilization of bones and the correction of bone deformities.

It covers bone deformity correction in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur. Gamma4 also treats both osteoporotic and osteopenic bone.

“Since 2004, the Gamma3 System has been the proven work horse of our Trauma business,” said Eric Tamweber, VP and GM, Stryker’s Trauma business unit. “But we aren’t proven because we have a legacy; we have a legacy because we are proven. That’s why we’re so excited to introduce Gamma4—an enhanced, modern product that is designed to fulfill our customers’ hip fracture needs.”

Stryker’s system features the Precision Pin to reduce the potential for ski…

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FDA clears new Viz.ai algorithm for measuring ventricles in identifying pulmonary embolism

[Image from Viz.ai]Viz.ai announced today that it received FDA 510(k) clearance for its automated RV/LV ratio algorithm as part of the Viz PE solution.

San Francisco-based Viz.ai designed its algorithm to quickly and accurately measure the diameter of the ventricles of the heart. The measurements provide the ratio of the maximum right ventricle (RV) diameter versus left ventricle (LV). Automating this risk indicator for pulmonary embolism (PE) enables care teams to respond quickly.

Viz.ai launched Viz PE in November 2021. It uses deep learning to identify suspected central and segmental pulmonary emboli in under two minutes. The integration of the new RV/LV algorithm adds an automated assessment of potential right ventricle dilation.

The company that this enables care teams make the right decision at the right time. No matter where the patient resides in the healthcare system, this ensures quick and appropriate care, Viz.ai said.

“The Viz.ai automate…

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Study backs next-gen Medtronic MiniMed 780G insulin pump

The Medtronic MiniMed 780G system. [Image from Medtronic]Medtronic (NYSE:MDT) today announced positive results from a study of its next-generation MiniMed 780G automated insulin delivery system.

Results from the ADAPT study, published in The Lancet Diabetes & Endocrinology, demonstrated improved glycemic control and treatment satisfaction among users of MiniMed 780G.

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Nevro wins multiple coverage options for spinal cord stimulation

The Senza system [image from Nevro]Nevro (NYSE:NVRO) today announced positive updates to multiple spinal cord stimulation (SCS) coverage policies.

Aetna’s new SCS policy explicitly covers PDN (painful diabetic neuropathy), effective Aug. 29, 2022. Aetna’s health plan covers approximately 22 million commercial lives.

Novitas and First Coast, Medicare Administrative Contractors (MACs) that represent 12 states, also provided a positive update. They published draft local coverage determinations (LCDs) that proposed updated coverage criteria to include PDN. This includes PDN refractory to conventional medical management for SCS devices with an explicit FDA approval to treat PDN.

The LCDs — if finalized — mean Medicare patients in all 50 states will receive coverage for PDN. This would add approximately 17 million covered Medicare lives, according to a news release. The review for the proposed LCDs is ongoing with finalization dates yet to be determin…

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The Evolution of Home Healthcare

by Clarissa Benfield, Global Director of Medical & Laboratory Equipment, Intertek

Monitoring Blood Oxygen Levels & Pulse Rate

Medical devices have been used in the home for many years to monitor vital statistics such as weight, blood pressure, fluid intake, oxygen saturation rate, etc. For many reasons, the market for these and other home-use medical devices has grown significantly, especially within the last several years, and they are bringing the convenience of home-based healthcare to patients who could previously only access these services in a clinical setting.

Some factors currently driving the growing marketing for home healthcare technology include an aging population, rising healthcare costs, the growing acceptance/use of telemedicine, and advances in home healthcare technology. During the COVID-19 pandemic, many patients were forced to receive treatments at home for a variety of ailments and conditions (non-COVID related) due to the restricti…

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