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In brief: PAP recall, indie outlook, OTC sensor, Kalogon hire

In brief: PAP recall, indie outlook, OTC sensor, Kalogon hire

WASHINGTON – BMC Medical retrospectively reported to the U.S. Food and Drug Administration (FDA) a recall of 20,160 Luna G3 APAP devices (model LG3600) distributed in the United States due to a firmware defect, the agency has reported.

The FDA has classified it as a Class I recall (FDA Recall Number: Z-2979-2026).

BMC has identified that the firmware version G3-2.00.76 with configuration G3 A20-31.cfg that is installed on these Luna devices contained a debug code. The company conducted a firmware upgrade to version G3-2.00.77 for 20,160 affected devices at the U.S. importer’s warehouse from October through December 2024.

After reporting the retrospective recall, BMC discovered that up to 196 units cannot be confirmed to have received the upgrade. When the device operated under all three extreme conditions simultaneously – high pressure, high respiratory rate and high peak flow – the debug code was triggered and activated, causing the device to display an 'Error' message and shut down.

Patients should continue using the device as prescribed and should not discontinue therapy before receiving a replacement. To date, BMC has received no complaints or serious adverse reports associated with this debug error.

Impacted products were manufactured from Sept. 11, 2024, to October 18, 2024, and distributed by BMC to its U.S. importer, React Health, from Sept. 20, 2024, to Oct. 19, 2024. Impacted products were distributed nationwide between Oct. 29, 2024, through July 6, 2026.

  • Related reading: Earlier this year, the FDA issued a warning letter to BMC Medical, citing regulatory violations involving the company’s G3X APAP devices. Through an inspection, the agency determined that BMC made significant design and software changes to a previously cleared Luna APAP device without submitting a new 510(k) premarket notification for FDA review.

New NCPA Digest offers updated outlook for indie pharmacies

KANSAS CITY, Mo. – Independent community pharmacies represent nearly 37% of all retail pharmacies in the United States, according to the 2026 NCPA Digest, which was released as part of the National Community Pharmacists Association’s Annual Convention, Oct. 3-6 in Kansas City, Mo.

The NCPA points out that it continues to be true that no single pharmacy has more stores than all independent pharmacies combined.

“Independent pharmacies continue to be resilient and providing health care services to people in communities large and small despite being faced with financial headwinds and ongoing challenges from anti-competitive PBM practices,” said NCPA CEO B. Douglas Hoey, pharmacist, MBA. “They’re offering personalized and high-quality care that makes a difference in the daily lives of their patients. As the digest shows, they’re increasingly integral to the infrastructure of American health care. The stronger independent community and long-term care pharmacies are, the stronger our health care system and population will be.”

Other data points from the digest, which was sponsored by Cardinal Health:

  • The estimated number of independent community pharmacies in 2026 is 18,988, essentially unchanged from the 18,960 locations reported in 2025.
  • Independent pharmacy represented a $103 billion marketplace in 2025, with more than 96% of sales for independents derived from the prescription department.
  • In 2025, the average prescription volume was 65,795 prescriptions per store, compared to 67,601 in 2024.
  • 81% of prescriptions at independent pharmacies are filled with a generic drug.
  • Government programs account for nearly half of all prescriptions sold in independent community pharmacies, meaning that the reimbursement strategies of government programs significantly affect the financial viability of independent community pharmacy.
  • This year, the digest adds a new primary type of pharmacy operation: retail-LTC combo. Thirty-four percent of independent pharmacies report being this primary type of operation, with a majority (56%) categorizing themselves as a full-line retail pharmacy.

To compare this year’s digest to last year’s, go here.

NCPA recognizes indie pharmacists at annual convention

KANSAS CITY, Mo. – The National Community Pharmacists Association (NCPA) is doling out numerous awards at its annual convention, including the 2026 NCPA Willard B. Simmons Independent Pharmacy of the Year Award to T.J. Woodward, PharmD, owner of Prescriptions to Geaux in Baton Rouge, La.

This annual award is given to a pharmacist who exhibits exemplary professional leadership, service to community and commitment to independent pharmacy. It is named in honor of Willard B. Simmons, a former executive secretary of NCPA (then known as the National Association of Retail Druggists or NARD) and a longtime trustee of the NCPA Foundation.  

Woodward and his wife, Aimee, who is also a pharmacist opened their first pharmacy in downtown Baton Rouge in 2013, after working for several years in retail chain pharmacies. He is actively involved in the pharmacy profession at both the state and national levels, serving on the board of directors of the Louisiana Independent Pharmacies Association and on NCPA’s Committee on State Legislation and Regulation.

Other pharmacists being recognized at the event, Oct. 3-6 in Kansas City, Mo.:

  • Steve Giroux, owner of Middleport Family Health Center in Middleport, N.Y., received the 2026 Calvin J. Anthony Lifetime Achievement Award. This award honors a pharmacist who has dedicated their career to the advancement of the pharmacy profession. Anthony, who died earlier this year, had a distinguished pharmacy career, starting as an independent community pharmacy owner in Stillwater, Okla. He went on to serve on multiple pharmacy organizational boards, as National Association of Retail Druggists (now NCPA) president from 1993-1994, and as NCPA’s executive president for a five-year term.
  • Jessica Hung, co-owner of Semmes Pharmacy in Semmes, Ala., received the 2026 NARD Ownership Award. This award, which this year was sponsored by Cascadia Pharmacy Group, recognizes an independent community pharmacist who embraces entrepreneurial spirit through promotion and demonstrated excellence in the field of community pharmacy ownership.
  • Xiaoyan Qin, PharmD, of Newton Center, Mass., received the 2026 Sharlea Leatherwood Memorial Trailblazer Award. This award is given to someone who is blazing the trail for independent pharmacy owners and future generations of independent pharmacy.
  • Blake Torres, co-owner and managing partner of West Side Pharmacy and Compounding, was named the recipient of the 2026 National Preceptor of the Year Award. This award recognizes a pharmacist who has made a significant contribution to the education of pharmacy students as a preceptor in a community practice setting.

The NCPA held its annual convention Oct. 3-6 in Kansas City, Mo.

Kalogon hires first chief technology officer

MELBOURNE, Fla. – Kalogon has named Marty Evans, former Meta and Magic Leaf executive, as its first chief technology officer (CTO). Evans, who has a total of 25-plus years of experience designing and shipping consumer hardware, will lead the company’s engineering and product development teams. "Marty has built some of the most sophisticated consumer devices on the market, and he knows how to make advanced technology disappear into the background of someone's day," said Tim Balz, founder and CEO of Kalogon. "That's exactly what great seating should do. His experience will help us move faster as we take what we've learned from wheelchair users into new places people sit, including the airplane cabin." Evans began his career as a U.S. Air Force avionics technician, maintaining F-16 and F-117A stealth fighters. After earning his electrical engineering degree with top honors, he entered the consumer electronics industry in 1999. He most recently served as vice president of engineering at Magic Leap, and before that was director of electrical engineering at Meta's Reality Labs. He has also built hardware at Valve and on Microsoft's Surface product line. He holds more than 20 patents spanning pressure sensing, wireless charging, electromechanical actuation, power management and accessory usability. "Joining Kalogon feels like coming full circle, getting closer to the technology again while applying the same principles of empathy-driven design to a new sector," said Evans. "In AR, we explored ways technology could extend someone’s abilities, from helping someone follow a conversation in a noisy room to making visual information easier to see. Adaptive seating calls for the same mindset – understanding what each person needs, then using hardware and thoughtful design to improve their daily experience."

Henry Schein marks 20 years of supporting cancer research and prevention

MELVILLE, N.Y. – Henry Schein is marking the 20th anniversary of Practice Pink, its global initiative bringing together health care professionals, supplier partners, employees and nonprofit organizations to support cancer research and prevention. Since Practice Pink began 20 years ago, Henry Schein and its partners have contributed more than $2.1 million to cancer-related causes, helping advance research, prevention, early detection, access to care and programs supporting people affected by cancer. “For two decades, Practice Pink has shown what is possible when our global healthcare community comes together around a shared purpose,” said Jennifer Kim Field, vice president, chief sustainability officer, Henry Schein. “What began as an effort to raise awareness has grown into a meaningful tradition of collaboration among our customers, supplier partners, Team Schein Members, and nonprofit partners. We are proud of what we have accomplished together and remain committed to supporting organizations making a difference for people impacted by cancer.” By offering its customers a variety of pink products, including health care consumables, practice supplies and apparel, Practice Pink enables customers to join Henry Schein in supporting these efforts. The Practice Pink program supports the Ronald McDonald House Charities in the U.S., as well as various organizations in Europe, including ALADINA (Spain), Cancer Research UK, KWF (The Netherlands), LILT (Italy), Odyssea (France), and others.

F&P Healthcare sells part of land for second campus in New Zealand

AUCKLAND, New Zealand – Fisher & Paykel Healthcare has entered into an agreement to sell 13 hectares of its 105-hectare site on Karaka Road in Drury, New Zealand, to Health New Zealand at a purchase price of $45.3 million. Health NZ intends to use the land to develop a future hospital facility to serve the growing South Auckland population. Fisher & Paykel Healthcare will retain the remaining land for the development of its planned second campus in New Zealand.  “We have worked closely with local health care providers since Dr. Nigel Rankin at Middlemore Hospital first suggested working with our research and development team,” said Lewis Gradon, managing director and CEO. “That collaboration has gone on to improve care and outcomes for patients in New Zealand and around the world. Locating a major new hospital alongside a world-class research and development campus creates a strong foundation for innovation in medical technologies. We look forward to working closely with the new facility in the future.” Settlement of the sale to Health NZ is expected between March and June 2027, subject to certain sale and purchase conditions. The impact of the sale will be reported as an abnormal item in Fisher & Paykel Healthcare’s income statement.

CQRC commends new fraud report, offers SOAR Act as reform

WASHINGTON – The Council for Quality Respiratory Care (CQRC) commends the House Committee on Energy and Commerce for releasing a report on emergent fraud trends impacting Medicare and Medicaid services across the nation. The report emphasizes the need for innovative tools and technology-based solutions to improve fraud detection and mitigation, and the need to move away from “pay and chase.” The CQRC points out that the Supplemental Oxygen Access Reform (SOAR) Act, H.R. 2902/S. 1406, would help the government reach that goal by, among other things, requiring the Centers for Medicare & Medicaid Services (CMS) to adopt a standardized electronic template that it says would help prevent fraudulent or abusive claims by providing the information needed to establish medical necessity before claims are paid. “The electronic template would improve clarity and accuracy in the Medicare review process, reducing improper payments linked to the current order process and contractors’ reliance on physician chart notes, thereby preventing fraud before it occurs,” the organization states. “In 2025, HHS estimated improper payments for oxygen cost the government approximately $80 million.” The CQRC urges the Energy and Commerce Committee to pass the SOAR Act. Previously, the CQRC commended the committee for holding a Jan. 8 legislative hearing on “Improving Medicare Payment Policies for Seniors” that highlighted the SOAR Act as reform for addressing barriers to care for individuals who need medical oxygen to manage their respiratory and pulmonary diseases.

Biolinq glucose sensor receives clearance for OTC use

SAN DIEGO – Biolinq Incorporated has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for over-the-counter (OTC) use of Biolinq Shine, the company’s needle-free glucose sensor designed to provide a simple, intuitive view of glucose, activity and sleep information in a single device with autonomous operation. The clearance expands access to Biolinq Shine without a prescription, marking the company’s latest regulatory milestone following FDA De Novo classification in 2025. “This clearance represents an important evolution in how people can access glucose information to build greater awareness of their metabolic health,” said Amy VandenBerg, chief regulatory and clinical officer at Biolinq. “The FDA conducted a thorough and rapid review of our submission, and we appreciate the agency’s rigor and engagement throughout the process.” Biolinq Shine is intended for adults ages 22 and older who are not on insulin, providing glucose range information to support general awareness of glucose patterns and trends. Worn on the forearm, the patch uses a color-coded LED to communicate real-time changes in glucose levels, signaling when glucose is within, above or below the target range. The company says it is the first glucose sensor with an integrated primary display that works with and without a phone.

California passes bill that eases home delivery for enteral nutrition

SACRAMENTO, Calif. – California Gov. Gavin Newsom in late September signed AB 1794, legislation that creates a clearer pathway for directly delivering medically necessary enteral nutrition products to patients in their homes, according to the California Association of Medical Product Suppliers (CAMPS). AB 1794 amends the state’s pharmacy law to expressly authorize pharmacists, manufacturers and wholesalers to participate in arrangements allowing enteral nutrition supplements or replacements to be delivered directly to a patient's residence. Deliveries must be supported by a valid order from an authorized prescriber and comply with applicable pharmacy standards of care. “The legislation provides greater statutory clarity for direct delivery arrangements, helping suppliers and their pharmacy partners serve patients who rely on prescribed nutritional products,” CAMPS stated in a bulletin. “It also recognizes the importance of home delivery in reducing unnecessary barriers to obtaining essential nutrition.” CAMPS says AB 1794 reflects the association's ongoing efforts to address regulatory challenges, support medical product suppliers and improve patient access to medically necessary products and services. The association applauds Assemblymember Rhodesia Ransom for authoring and advancing the legislation, and thanks the legislators, industry partners and CAMPS members who contributed to the legislative effort.

Dynarex recognizes EMS for inclusive emergency care

MONTVALE, N.J. – Dynarex Corp. has honored Lt. Sarah Studley of Orange County Fire Rescue as the recipient of the 2026 Dynarex First Responder Caring Award (FRCA). The annual award celebrates EMS professionals who have demonstrated exceptional compassion, leadership and commitment to the communities they serve. "The strength of EMS is driven by professionals who push the field forward every day," said Shauna Winston, Dynarex interim vice president of global sales/category manager. "Lt. Studley has advanced inclusive emergency care, strengthening first responders' ability to meet the needs of those they serve. Dynarex is honored to recognize her and proud to continue our longstanding support of the EMS community." During the opening ceremony of EMS World Expo 2026 in Orlando, Fla., Kimberly Grace, Dynarex regional vice president, sales – east, presented Studley with the award as part of the National EMS Awards of Excellence. Studley, a firefighter/paramedic with Orange County Fire Rescue, established the department's Functional Needs Registry, a voluntary program that lets residents securely provide important information before an emergency occurs. Participants can document medical conditions, mobility limitations, and communication preferences, giving first responders critical insight into individual needs before they arrive on scene. In 2025, Studley expanded the department's support for patients with sensory needs by introducing sensory bags on every Orange County Fire Rescue transport unit. The bags give responders resources to help minimize sensory overload, increase patient comfort, and support clearer communication throughout care and transport. Studley also leads autism and sensory-awareness training through the department's Preceptor Academy, helping responders identify sensory triggers and use appropriate de-escalation strategies.

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