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In brief: Bid carve out, med device investigation, Medline IPO 

In brief: Bid carve out, med device investigation, Medline IPO 

WASHINGTON – Reps. Neal Dunn, R-Fla., and Greg Murphy, R-N.C., are leading a sign-on letter urging the Centers for Medicare and Medicaid Services (CMS) not to move forward with expanding the competitive bidding program to include ostomy, urological and tracheostomy supplies. They seek signatures by close of business this Friday, Oct. 3. 

“We respectfully request that the proposal for inclusion of these products be withdrawn as we believe it would conflict with the administration's goals to strengthen American manufacturing, secure our medical supply chains from foreign adversaries, and protect the health and well-being of our nation's most vulnerable citizens,” the letter states. 

Stakeholders must ask their representatives to sign the letter this week. 

Dunn and Murphy make the case that bidding these supplies sends the wrong message to U.S. manufacturers that employee engineers, researchers and product developers, and U.S. suppliers that employ thousands of workers, contributing to local economies in rural and other communities across the nation. 

“Competitive bidding threatens to destroy many of these businesses overnight, transferring this market to foreign competitors who have no commitment to American workers, American communities or American patients,” the letter states. 

Dunn and Murphy also make the case that: 

  • “Ostomy, urological, and tracheostomy supplies represent a relatively small portion of overall Medicare spending, and these products, despite their significance for patients, are low cost. Any savings that might possibly be achieved through competitive bidding will be more than offset by the increased costs associated with managing health care complications, serious kidney and skin infections, emergency department visits, and hospitalizations.” 
  • “Our offices have received numerous communications from constituents, including seniors. These individuals, and the doctors and nurses who care for them, understand better than anyone that ostomy, urological, and tracheostomy supplies are not commodity items that should be subjected to a ‘lowest bidder’ procurement model. They are highly individualized prosthetics.” 

Dunn and Murphy urge the administration to, instead, focus on targeted enforcement measures to address any fraud related to supplies. 

Gov’t launches investigation into medical equipment import vulnerabilities 

Industry stakeholders worry an investigation could lead to higher tariffs 

WASHINGTON – The U.S. Department of Commerce has initiated an investigation into the potential national security risks associated with importing personal protective equipment (PPE), medical consumables and medical equipment, according to a Sept. 29 notice of request for public comments. 

“While this may sound like simple information gathering, the outcomes of this investigation have serious implications for our industry, with potential impact to nearly every segment of the medical supply chain,” VGM Government Relations stated in an alert. “We, as an industry, need to ensure the department understands how its decisions will impact our industry’s manufacturers, providers, and ultimately, our nation’s patients.”  

The Department of Commerce is particularly interested in comments and information on the following: 

  • The current and projected demand for PPE, medical consumables, and medical equipment, including devices, in the United States; 
  • The extent to which domestic production of PPE, medical consumables, and medical equipment, including devices, can meet domestic demand; 
  • The role of foreign supply chains, particularly of major exporters, in meeting United States demand for PPE, medical consumables, and medical equipment, including devices; 
  • The concentration of U.S. imports of PPE, medical consumables, and medical equipment, including devices, from a small number of suppliers or foreign nations and the associated risks; 
  • The impact of foreign government subsidies and predatory trade practices on the competitiveness of PPE, medical consumables, and medical equipment, including devices, manufacturers, in the United States; 
  • The economic impact of artificially suppressed prices of PPE, medical consumables, and medical equipment, including devices, due to foreign unfair trade practices and state-sponsored overproduction; 
  • The potential for export restrictions by foreign nations, including the ability of foreign nations to weaponize their control over supplies of PPE, medical consumables, and medical equipment (including devices); 
  • The feasibility of increasing domestic capacity for PPE, medical consumables, and medical equipment, including devices, to reduce import reliance; 
  • The impact of current trade policies on domestic production of PPE, medical consumables, and medical equipment, including devices, and whether additional measures, including tariffs or quotas, are necessary to protect national security; 
  • The potential for foreign control or exploitation of supply chains for PPE, medical consumables, and medical equipment, including devices, supply chain; 
  • The ability of foreign persons to weaponize the capabilities or attributes of foreign-built PPE, medical consumables, and medical equipment, including devices 

The department defines medical equipment as durable equipment, tools and machines used in health care to support patient care. Examples include but are not limited to wheelchairs, crutches and hospital beds. 

The investigation, launched on Sept. 2, 2025, is being conducted under Section 232 of the Trade Expansion Act of 1962.  This act empowers the U.S. government to investigate the effects of certain imports on national security. Previously, it was used to investigate the steel industry and resulted in higher tariffs. 

The department is accepting public comments until Oct. 17. 

Coming soon? Medline eyes $5B IPO, according to reports 

NORTHFIELD, Ill. - Medline may soon be ready to pull the trigger on an initial public offering (IPO), according to Bloomberg and other news outlets. The company may file for an IPO as early as late October in a bid to raise $5 billion, potentially valuing it at $50 billion, they report. Earlier this year, Medline confidentially submitted a draft registration statement on Form S-1 to the U.S. Securities and Exchange Commission for a proposed IPO of its common stock. In 2021, the company announced it had received outside investment from private equity firms Blackstone, Carlyle, and Hellman & Friedman in a deal reportedly worth more than $30 billion. Since then, the company has made multiple moves to strengthen its role as a strategic partner, including joining forces with Microsoft to address supply chain complexity. In 2023, Medline promoted Jim Boyle to serve as CEO, and Jim Pigott as president & COO, culminating a five-year succession planning process

Biolinq’s multi-function biosensor receives FDA De Novo Classification 

SAN DIEGO – Biolinq has received De Novo Classification from the U.S. Food and Drug Administration for its lead product, Biolinq Shine, a patch on the forearm that provides real-time glucose feedback through a primary color-coded LED display, visible with or without a phone. The device provides additional insights, such as activity and sleep trends, through a mobile app. The company says Biolinq Shine, initially marketed to people with Type 2 diabetes, is the first wearable biosensor integrating glucose, activity and sleep information in a single device with autonomous operation. “Biolinq Shine is a first-of-its kind biosensor designed to support metabolic health for people with diabetes who are not dependent on insulin,” said Dan Bradbury, chairman of Biolinq. “By automatically tracking glucose levels, physical activity and sleep information, this technology offers meaningful insights that can encourage healthier choices every day.” Biolinq points to American Diabetes Association guidelines that highlight the importance of time-in-range (TIR) for glucose levels in optimizing metabolic health, recommending that individuals diabetes strive to remain within a standard target glucose range at last 70% of the time. It says achieving this target range can be challenging with infrequent and episodic glucose measurements, and a new generation of continuous glucose sensors like Biolinq Shine can be a valuable tool in managing metabolic health. “As long-standing supporters and investors of Biolinq, Alpha Wave remains confident in their ability to deliver on a bold, innovative vision for biowearables,” said Rick Gerson, chairman of Alpha Wave Global. “Biolinq is on the path to redefine how society thinks about cardiometabolic health and wellness, driving the next wave of innovation with a profound multi-analyte biosensor platform.” 

VGM hosts Senate hopeful Josh Turek 

WATERLOO, Iowa – VGM Group on Sept. 22 hosted its first “Meet the Candidate” forum by welcoming Josh Turek, a Democratic candidate for the U.S. Senate seat soon to be vacated by Sen. Joni Ernst, R-Iowa. Turek, a state representative who currently represents Iowa House District 20, is widely recognized for his advocacy on disability rights and health care reform. As a wheelchair user and two-time Paralympic gold medalist, he brings a deep personal perspective to issues affecting the disability community. At his visit to VGM, Turek emphasized the importance of ensuring access to high-quality DMEPOS products and services. He also spoke about the broader implications of health care affordability, framing his campaign around “kitchen-table issues” that resonate with everyday Iowans. VGM encourages stakeholders to take advantage of the ramp up to the next primary election season to build relationships and advocate for the industry’s priorities. 

Inogen welcomes new chief technology officer 

GOLETA, Calif. - Inogen has appointed Naga Rameswamy, formerly vice president and global head of digital health platforms for Alcon, as its CTO effective Sept. 29. “Naga’s deep background in digital health and connected device innovation makes him an ideal fit for Inogen as we continue to expand our technology leadership,” said Kevin Smith, president and CEO of Inogen, “His ability to integrate software, data, and devices to improve user experiences will be instrumental in advancing our pipeline and strengthening our competitive positioning in today’s underserved respiratory care market. We look forward to his contributions as a key member of our leadership team.” Prior to Alcon, Rameswamy spent nearly 20 years at GE Healthcare, culminating as vice president of digital health engineering. He brings more than two decades of leadership in the medical device industry spanning innovation, R&D and digital transformation. He has advanced experience in secure device connectivity, remote diagnostics, fleet reliability and care management platforms across diagnostic imaging, ultrasound and patient monitoring modalities. He has scaled global engineering teams and partnered closely with quality, regulatory, manufacturing, sales, service and cloud infrastructure to deliver compliant, secure, and intuitive products and solutions that improve serviceability, extend product lifecycles, and enhance experiences for patients, caregivers, and clinicians, Inogen says. 

VGM Canada’s Steve Cranna to retire 

TORONTO – Steve Cranna of VGM Canada will retire as director of government relations and new business development at the end of September. He has agreed to stay on in a consulting role for the next six months. During that time, he will work closely with Dominique Sedlezky, who will assume his government relations responsibilities. “Steve has been a cornerstone of our success at VGM Canada throughout his 19-year career of dedicated service,” said Dave Davies, president of VGM Canada. “The many roles he has played over the years have been instrumental to the overall success of not only VGM but also to many of our customers.” Since joining VGM Canada in 2006, Cranna has played a pivotal role in advancing the interests of the home medical equipment (HME) sector. His work with government bodies at the federal, provincial and municipal levels helped shape policies that support industry growth and sustainability—directly benefiting VGM Canada members and stakeholders nationwide. In addition to his advocacy efforts, Cranna oversaw a range of business services and managed key programs and contracts that enhanced operational efficiency for suppliers, manufacturers and retailers across Canada. “It has been an honor and privilege to work with the team at VGM to leverage our resources and skills to positively impact not only our members’ businesses but the broader industry for these 19 years,” said Cranna. “I have been privileged to collaborate with many brilliant leaders throughout my career, and together we have been able to have a positive impact on the industry. There are still headwinds and much to be done in an industry I care deeply about.” 

Encore Health readies to host respiratory professionals 

LIVINGSTON, Tenn. - Encore Healthcare will host the Smoky Mountain Symposium 2025 (SMS 2025) Oct. 23-24 at the Ramsey Hotel & Convention Center in Pigeon Forge, Tenn. Attendees can earn up to 12 respiratory CEUs or 10 sleep CEUs, as well as gain insights into the latest innovations, compliance changes and best practices. “Our goal with SMS is to combine world-class education with a fun, supportive atmosphere,” said Zach Gantt, CEO of Encore Healthcare. “This isn’t just a conference—it’s a community. And the Smokies make a perfect backdrop to connect, learn and grow.” Highlights of SMS 2025 include: 

  • Expert-led CEU-accredited sessions across two days 
  • Separate educational tracks for respiratory therapists and sleep techs 
  • Exhibitor hall showcasing 30-plus vendors with the latest technologies and services 
  • Networking opportunities in a relaxed and scenic environment 

For more information and to register visit https://www.encorehc.com/sms.  

Viemed completes share repurchase 

LAFAYETTE, La. - Viemed Healthcare has completed all repurchases authorized under its previously announced share repurchase program. "Completing this share repurchase program highlights both our confidence in Viemed's long-term outlook and our ongoing commitment to enhancing shareholder value,” said Casey Hoyt, Viemed's CEO. “With our strong balance sheet and ample liquidity driven by increasing free cash flow, we remain well positioned to continue investing in growth opportunities while returning capital to shareholders." On June 9, Viemed announced that its board of directors had authorized the repurchase of up to 1,976,441 common shares, representing about 5% of the total issued and outstanding shares at the time of authorization. The company has completed the repurchase and cancellation of all 1,976,441 common shares authorized under the program, for a total cost of approximately $13.2 million at a weighted average price of $6.69 per share, before taxes. The repurchases were executed through open market transactions in accordance with applicable securities laws.  

Arecor, Sequel partner to advance diabetes treatment through clinical trials and beyond 

CAMBRIDGE, U.K. - Arecor Therapeutics, a biopharmaceutical company focused on drug development and delivery in diabetes and other cardiometabolic diseases, has signed a co-development agreement with Sequel Med Tech, a company that is developing insulin delivery technologies. Part of the agreement: 

  • Combining Arecor’s AT278 (500U/ml) with Sequel’s twiist automated insulin deliver (AID) system powered by Tidepool; and 
  • Implementing a royalty financing agreement with Ligand Pharmaceuticals to raise non-dilutive capital of up to $11 million. 

“The co-development agreement for AT278 and the non-dilutive fund raising via the monetization agreement are both major strategic achievements for Arecor,” said Sarah Howel, CEO of Arecor. “The Sequel agreement marks a key milestone, furthering our ambitions to realize AT278’s significant benefits for people living with diabetes, as well as building substantial value for our shareholders. The funding realized through the monetization of specific royalty rights enables us to accelerate AT278’s clinical development and extends our cash runway to 1H 2027 without diluting our shareholders.” 

Under the terms, Arecor and Sequel will co-fund all trial-enabling development activities for the AT278-AID System development program to achieve Phase 2 trial-ready status. Each company will commit up to $1.3 million to accelerate and fund all Phase 2 clinical trial-enabling development work. This will include regulatory interactions and filings with the U.S. Food and Drug Administration (FDA), clinical trial batch manufacturing and AID System compatibility work. Work will commence immediately and is expected to be completed during the first half of 2026, culminating in the filing of an IND (Investigational New Drug). If approved, the program would be ready to enter a pivotal Phase 2 clinical study during 2H 2026. 

Longer term, both companies have confirmed their strategic intent to enter a broader, co-development and commercialization partnership. This would enable the further development and future commercialization of AT278 in a next generation AID system, serving a key unmet patient need in a high value market. 

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