Author: Newsbit

Rural hospitals are preparing to lose billions of dollars from President Donald Trump’s signature tax and spending cut bill signed into law this summer.

Dozens, already on the brink, have warned they face the prospect of closure or reduced services because of the bill’s cuts to Medicaid, which is funded by federal and state governments and provides health care coverage for the poorest Americans.

At a cabinet meeting Tuesday celebrating working Americans, Health and Human Services Secretary Robert F. Kennedy Jr. asserted that a historic “ infusion of cash ” is on the way for rural hospitals throughout the country.

“Right now we spend 7% of Medicaid dollars on rural hospitals,” he said. “They’re getting the short end of the stick.” To address that, he said a new fund — established in the legislation — will give rural hospitals an extra $10 billion every year. AP News

Carlsmed, Inc. reported financial results for the second quarter ended June 30, 2025.

“Our strong commercial performance was driven by the continued adoption of our highly differentiated AI-enabled aprevo® technology platform and growing recognition of its ability to deliver more favorable patient outcomes than legacy devices,” said Mike Cordonnier, Chairman and CEO of Carlsmed. “Building upon our momentum in personalized lumbar fusion surgery, in July we successfully completed the first personalized cervical spine surgery using our aprevo® technology platform, launching in 2026. We enter the second half of 2025 well positioned for continued scale as we become the new standard of care in spine fusion surgery.”

Second quarter financial results & recent highlights

• Revenue was $12.1 million for the second quarter of 2025; a 99% increase compared to $6.1 million for the second quarter of 2024. This increase was driven by the increased number of surgical procedures utilizing the aprevo^® technology platform in the second quarter of 2025, with average revenue per procedure flat between these periods.
• Gross profit for the second quarter of 2025 was $8.9 million compared to $4.6 million for the second quarter of 2024, due to our increased revenue. Gross margin was 73.4% for the second quarter of 2025, compared with 75.0% for the second quarter of 2024; this decrease was primarily driven by expedite production fees charged by our contract manufacturer in the second quarter to meet customer timing requirements.
• Operating expenses were $15.4 million for the second quarter of 2025, compared with $10.9 million for the second quarter of 2024.
  • Research and development expenses were $4.2 million for the second quarter of 2025, compared with $4.0 million for the second quarter of 2024. This increase was primarily driven by higher personnel costs to support product development and artificial intelligence initiatives, partially offset by lower prototype and materials costs and reduced COMPASS registry costs following enrollment completion in second half of 2024.
  • Sales and marketing expenses were $7.9 million for the second quarter of 2025, compared with $4.9 million for the second quarter of 2024. This increase was primarily driven by personnel additions and variable sales expenses associated with our revenue growth, as well as an increase in marketing expenses.
  • General and administrative expenses were $3.3 million for the second quarter of 2025, compared with $2.0 million for the second quarter of 2024. This increase was primarily due to personnel additions to support business growth and costs associated with the transition to being a publicly traded company, including associated legal, accounting, and other professional fees.

• Net loss was $6.8 million for the second quarter of 2025, compared to a $6.3 million net loss for the second quarter of 2024.
• Adjusted EBITDA loss was $6.2 million for the second quarters of 2025 and 2024.

• Cash and cash equivalents were $33.5 million as of June 30, 2025. The Company received $93.5 million of net proceeds, after deducting underwriting discounts and commissions and before other additional offering expenses, from its initial public offering in July 2025.
• The first personalized cervical spine surgery using the AI-enabled aprevo^® technology platform was performed.
• aprevo^® cervical procedures received CMS New Technology Add-On Payment (NTAP) reimbursement, in effect October 1, 2025.

2025 full year financial outlook
Revenue for the full year 2025 is expected to be in the range of $45.5 million to $47.5 million, representing growth of 67% to 75% over 2024.
TheNewsBit Bureau

The global medical device supply chain is immensely complex, accounting for billions of dollars in trade each year. With that, millions of lives depend on its swift delivery and provision of crucial medical equipment—meaning also, regrettably, that companies on the chain are at increasing risk from cyber criminals.

Managing cyber risks in the chain, however, requires businesses to be more than just careful with how they handle their own data and systems. As part of a wider, global chain, they’re at the mercy of third-party vendor practices—and so are millions of innocent consumers.

Let’s explore the current threat landscape affecting medical device supply, and how companies on the chain can better protect themselves and their customers.

Understanding the Cyber Threat Landscape in Medical Device Supply Chains
The healthcare industry remains the third most-attacked worldwide, largely due to the sensitivity of the data held and the services provided.

By disrupting companies on the medical device supply chain, for example, hackers put suppliers and care providers under immense pressure to restore service as quickly as possible.

Ransomware, which locks down systems until ransom payments are made to attackers, can prevent crucial devices and support from reaching people, meaning organizations on the chain must be on high alert to prevent such extortion from taking hold.

HIMSS’ 2024 Healthcare Cybersecurity Survey explains that ransomware threats in the industry have remained steady since at least 2018—meaning that while the methodologies to handle evolving threats are improving, this type of attack is never going away.

And yet, businesses in the device supply chain must carefully consider the security postures of the vendors they work with, not just their own. Any weaknesses in vendor cybersecurity can lead to hackers intercepting communications on the supply chain, potentially finding backdoors into firms that otherwise have robust protections.

What’s more, typical cyberattacks such as phishing and social engineering take advantage of supply chain employees who lack adequate training and knowledge.

Worryingly, KLAS Research found that the majority of healthcare firms take a “when, not if” position on cybersecurity and threat response.

With generative AI making threats to the device supply chain more sophisticated, this all culminates in a stark wake-up call for businesses and vendors.

Regulatory expectations and compliance requirements
Beyond threats to customer data and operational lockdowns, businesses in the medical device supply chain also have regulatory expectations and must ensure they are adequately protected in line with compliance standards.

HIPAA, the Health Insurance Portability and Accountability Act, for example, regulates healthcare businesses (including medical device users and suppliers) with regard to how they handle, protect, and store patient data.

Within medical device manufacturing itself, the U.S. Food and Drug Administration (FDA) applies specific cybersecurity guidance in line with the Consolidated Appropriations Act of 2023.

Therefore, businesses should already be aware of and following security recommendations set by regulators—and if not, should consider setting up their own security templates or frameworks, or using a pre-established framework to guide along.

Implementing a robust cybersecurity framework
The ideal cybersecurity framework and incident response plan will look different for every organization on the supply chain. However, there are key steps they can take to ensure they build a reactive, proactive framework that keeps data and operations safe, and which continues to maintain compliance.

Here are a few suggested steps businesses might take to protect themselves, at least initially:

• Use a recommended security framework, such as NIST CSF. NIST CSF 2.0 is the latest version of a widely used cybersecurity template that helps businesses—such as those on the device supply chain—to ensure they follow recommended practices to protect data and operations, and to stay compliant.
• Carefully vet vendors. As mentioned above, medical device suppliers and manufacturers are frequently at the mercy of the security standards set by partners they work with. Therefore, it’s vital to hold potential new partners to account for their security measures, and to establish a framework that you can regularly revisit and reanalyze together.
• Apply zero-trust practices. An effective cybersecurity framework must never take trust for granted. Even with long-standing partners and trusted devices, firms should apply strict controls to verify connections and restrict access to data and operations unless several factors have been confirmed.
• Run regular tests and scans as part of ongoing framework reviews. Medical device firms should always run penetration tests and vulnerability scans to search for weaknesses in systems and networking that escape the naked eye. Tiny flaws such as misconfigurations can, for example, still provide backdoors to hackers.

Best practices for ongoing cyber risk mitigation
Beyond setting up a reliable, proactive cybersecurity framework, medical device manufacturers and suppliers should take regular steps to mitigate risks and prevent threats from taking hold.

Here are a few best practices that supply chain firms should consider to tighten up their ongoing cybersecurity:

• Regularly refresh and rewrite contracts and agreements with vendors and partners to establish mutual security targets and auditing.
• Work with cybersecurity professionals and use threat intelligence tools to stay ahead of the latest threats with recommended software.
• Regularly top up employee knowledge on how the supply chain is connected, the risks that are involved, and how to secure data and personal access.
• Develop incident plans and backup procedures in the event of the worst-case scenario happening—run thorough, targeted risk analyses to grade how likely risks are to occur.
• Collaborate and share knowledge with other businesses and thought leaders on the supply chain—are there any practices you could take inspiration from, or any you could share with your partners?
• When using hardware such as RFID scanners and IoT devices, take care to regularly update firmware and reassess how systems are connected—according to the World Economic Forum, cyberattacks targeting IoT in particular are increasing.

Conclusion
The medical device supply chain and the wider healthcare industry are more at risk now than ever before from sophisticated hacking and cybersecurity threats. Although efforts to prevent these threats are, in turn, becoming more sophisticated, there is still plenty for businesses to do in terms of vigilance and preparedness.

Take our advice and don’t make cybersecurity an afterthought—plan ahead, set up analytics and work with security professionals—and, most of all, choose vendors you can safely trust across the chain. Medical Product Outsourcing

Chief Minister N Chandrababu Naidu has announced the launch of the Bharat Biodesign Research and Innovation (BRAIN) programme in collaboration with global biodesign leaders at the Ratan Tata Innovation Hub in Amaravati.

The announcement followed a meeting with members of the Asia-Pacific (APAC) Biodesign Alliance, who are in India for their annual summit. The delegation included representatives from the USA, Australia, Israel, Taiwan, Japan, Ireland and Singapore.

The discussions centred on advancing healthcare innovation, medical technology, and entrepreneurial capacity building in India, with a special focus on positioning Andhra Pradesh as a hub for next-generation health technology solutions.

Naidu interacted with Dr Rakesh Kalapala, President of the AI & MedTech Alliance Foundation, Prof Anurag Mairal of Stanford Biodesign, and Naresh Kumar Pagidimarry, Director of Bharat Biodesign. The dialogue culminated in the launch of the Bharat BRAIN initiative, to be spearheaded by the AI & MedTech Alliance Foundation in collaboration with the APAC Biodesign Alliance and Stanford Biodesign, USA.

“The Bharat BRAIN programme will not only bring the best of global health innovation to Andhra Pradesh but also create local solutions that can be scaled across India and emerging markets,” Naidu said.

The initiative aims to make AP a hub for global health technologies and digital health innovation, with a strong focus on preventive healthcare. The New Indian Express