Avvio Medical Proudly Announces ISO 13485 Certification, Marking a Major Milestone in Global MedTech Readiness
SAN FRANCISCO, June 26, 2025--(BUSINESS WIRE)--Avvio Medical, Inc., a clinical-stage medical device company focused on transforming the treatment of kidney stone disease, is proud to announce that it has successfully achieved ISO 13485:2016 certification following its initial audit conducted by BSI (British Standards Institution). This globally recognized certification demonstrates Avvio's compliance with international standards for medical device quality management systems and reflects the company's unwavering commitment to excellence, patient safety, and operational rigor.
"This milestone is more than a regulatory requirement—it represents the fulfillment of our promise to stand up a full-scale medical device company," said Paul Molloy, CEO of Avvio Medical. "Through disciplined execution, a culture of continuous improvement, and a mindset grounded in honor, behavioral integrity, and precision, we have built a foundation for scalable, global operations." He added, "The quality culture at Avvio is not just a box-checking exercise. We embed it through storytelling, structured messaging, and principles drawn from disciplines of Lean and KAIZEN and a culture Bushidō. As we shared with the BSI audit team, our internal motto is #ImproveEverything—and this certification illustrates that we live by it."
The ISO 13485 certification now enables Avvio to fully qualify its manufacturing and design processes for commercial scaling, pursue CE marking for international distribution, and reinforce confidence among global partners, investors, and regulators. The achievement is a major step toward the company's upcoming 2026 commercial launch in the U.S. market. With this certification, Avvio affirms that it is not only compliant—but built to lead.
About the Enhanced Lithotripsy System (ELS)
The AVVIO ELS introduces microbubble enhanced acoustic cavitation lithotripsy that enables kidney stone treatments to move out of the traditional operating room and into more accessible outpatient and office-based settings. The system provides a single, minimally invasive therapy suitable for Ambulatory Surgery Centers (ASCs) and cystoscopy suites, without requiring general anesthesia, fluoroscopy, or costly capital equipment. This innovation offers compelling clinical and economic advantages for both patients and providers.
About Avvio Medical
Avvio Medical is a privately held medical technology company based in San Francisco and dedicated to transforming the treatment of urinary stones. Its breakthrough platform is designed to improve patient experience, reduce healthcare costs, and expand access to care by offering a fast, minimally invasive solution suitable for a wide range of clinical settings. The company's system eliminates the routine need for general anesthesia or X-ray imaging, streamlining the treatment pathway for both patients and healthcare professionals.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250625553966/en/
Contacts
Media Contact: Paul MolloyChief Executive OfficerAvvio Medical, Inc.Email: paul.molloy@avviomed.com Tel: (415) 887-2037
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Forbes
10 minutes ago
- Forbes
The Cyber Risk SMBs Can't Afford To Ignore
AI-driven threats are rewriting the rulebook. Here's the new cybersecurity playbook every small business must adopt before it's too late June just marked National Cybersecurity Education Month, an effort to raise awareness and expand the cybersecurity workforce. While public understanding is growing, so is the scale and sophistication of attacks. In the age of AI, threats no longer target only governments and large organizations. Cyberattacks now strike in unexpected places, putting individuals, SMBs, and entire systems at risk. Awareness alone isn't enough. Are we prepared? A recent conference held at Nasdaq by the Digital Evolution Institute explored the digital fabric comprising AI, data, and cybersecurity, and put a fascinating spotlight on the growing and unexpected risks and consequences. Byron Loflin, Nasdaq Board Excellence Center at the conference Digital Evolution Institute founder Julia Valentine stressed throughout the conference the shift from cyber crises as technical incidents to business and leadership-level challenges, and explained why being proactive in cyber crisis preparedness is no longer a luxury but a must-have. Cyber risk is a business risk Valentine, Presidential Lifetime Achievement Award recipient, entrepreneur, and a long time investor, is also the founder of AlphaMille, a global technology consulting firm specializing in digital and physical security, stressed at the conference that 'Companies cannot look to the government to protect them from cyberattacks in the AI era. Digital exposure should be treated as any other initiative that creates revenue, reduces cost, and mitigates risk,' she said, offering a familiar example from 2021, when R.R. Donnelley & Sons (RRD), a global provider of business communication and marketing services, which went through a ransomware attack that exposed sensitive client data. In 2024, the SEC reached a $2.125 million settlement with RRD for violating the internal controls and disclosure controls provisions of federal securities laws. As part of remediation, RRD revised incident response policies and procedures, adopted new cybersecurity technology and controls, updated employee training, and increased cybersecurity personnel headcount - all basic cybersecurity measures that shareholders increasingly expect to be put in place as a normal course of business. 'The 'R.R. Donnelley' case was a wake-up call,' Valentine now says. 'Despite being a data-intensive company, they missed key warning signs. This cost them millions and damaged client trust. Overlooking cybersecurity doesn't just increase risk; it sets a company up for sudden and devastating failure.' Presidential Lifetime Achievement Award recipient, entrepreneur, and a long time investor, Julia ... More Valentine at the conference. While awareness is supposedly on the rise, cybercrime losses have been steadily increasing, and projections indicate a continued upward trend. Globally, cybercrime costs are projected to reach $10.5 trillion annually by 2025, according to Cybersecurity Ventures. The annual cost of cybercrime in the U.S. alone is estimated to be around $639 billion in 2025. According to Valentine, three things need to happen to change the trend: 'Cybersecurity needs to be elevated to the board level. The board needs to calibrate the right amount of information it needs for effective oversight, and the company needs to right-size its cybersecurity defenses.' During the conference, broad discussions by key industry leaders explored this shift in priorities from multiple angles. 'As fiduciaries, we are now responsible for the resilience of our organizations, not just our balance sheets.' From a management and board perspective, it was made clear that the change starts there: 'Cybersecurity must be viewed not as an IT expense, but as a strategic differentiator. Boards need fluency in incident response, third-party risk, threat intelligence, and yes, a solid recovery plan. Because a breach today is no longer just a technical failure, it's a governance failure.' SMBs Are Losing the Battle to Cybercrime In today's digital economy, small and midsize businesses (SMBs) are no longer flying under the radar of cybercriminals. In fact, they've become prime targets. According to recent industry reports, nearly 60% of SMBs experience a cyberattack each year. 'Many SMBs operate under the dangerous assumption that they're too small or insignificant to attract cybercriminals,' she says. 'In reality, attackers often see SMBs as low-hanging fruit, companies with valuable data but weaker defenses. Whether it's financial records, employee data, or client information, your business is a digital goldmine to hackers.' Many small businesses are at serious risk without realizing it. Common signs include not using multi-factor authentication, not knowing what systems or tools are in use, and ignoring alerts or phishing emails. Relying on basic IT support, skipping regular backups, running outdated software, and lacking a clear response plan all leave the door open to attacks. Even being denied cyber insurance can be a red flag. So beyond misconceptions, what's actually preventing SMBs from getting the protection they need? Valentine outlines five practical barriers that prevent SMBs from getting the cybersecurity protection they need: Cyber protection is not out of reach. SMBs need focused, outsourced, and staged solutions, not bloated enterprise packages. "SMBs must treat cybersecurity like a business imperative." With the different views discussed at the conference, a new 'playbook' was created with the critical steps each business, big and small, must take. Valentine is now outlining The New Cybersecurity Playbook for SMBs: 7 Essential Steps: 'Cybersecurity is a boardroom concern and a business imperative,' she concludes. 'A modern, tested cyber playbook is the best line of defense.'
Forbes
10 minutes ago
- Forbes
New MTU-IACMI Partnership Expands Metallurgy Education And Outreach
Casting—pouring molten metal into molds to create new components—is one of the fundamental skills ... More covered by IACMI's METAL program. With all the focus currently on skilled trades training and recruiting, one vital area that hasn't gotten a lot of attention is the fundamental processes of making things from metal. The Metallurgical Engineering Trades Apprenticeship & Learning program was founded in June 2024 to help with that, and its latest win is a new partnership with Michigan Technological University in Houghton, Michigan. METAL is led by the Institute for Advanced Composites Manufacturing Innovation with funding from the Department of Defense's Industrial Base Analysis and Sustainment program, It focuses breakthrough education and awareness efforts on the metallurgical processes of casting, forging and plate rolling. The new partnership will provide workforce training to strengthen metalworking industries. As METAL's newest hub operator, Michigan Tech joins The Ohio State University, the University of Tennessee in Knoxville, the University of Alabama in Birmingham, and Pennsylvania State University in helping deliver METAL's nationally recognized curriculum, facilitate instructor certification, and launch boot camps and academic pathways for metalworking professionals. MTU will also integrate METAL training into its existing Summer Youth Programs, offering an introduction to metalworking, metallurgy and materials science to high school students from across the Upper Midwest. Plate rolling—running hot metal through progressive roll mills to create thinner slabs—is another of ... More the basic processes in the METAL program. 'We're trying to create exposure,' Greg Harrell, workforce coordinator at IACMI, told me in an interview. 'K through gray is what we call it, from kindergarten all the way through to adults, to expose them to different types of metallurgical-type processes.' 'So Michigan Tech, one of the ones things they're doing is summer youth programs,' added Michael Kubacki, project coordinator at IACMI added. 'We're able to help fund those so that they have more casting and forging curriculum, or expand on it, add more summer youth programs to try to get more kids interested. It can also drive them to take a metal or material science or engineering course at school so you can help drive admissions into the higher degree pathways for engineering.' The MTU hub curriculum will combine interactive online learning with in-person casting and forging boot camps at MTU's state-of-the-art labs. Future educational modules will incorporate training on automation in casting and forging and will open pathways to employment in critical industry roles. 'We have a fully working foundry,' Alexandra Glover, assistant professor of materials science and engineering at MTU, said in an interview. 'We have full-time staff who work there. So it's a really easy thing for us to slot in. As a department, we've taught a very rigorous castings class for a very long time, and so curriculum-wise, a lot of the activities line up really well with METAL. We're used to having large groups of students in our foundry all the time.' Forging—using powerful presses to shape hot metal—is another of the METAL program's fundamental ... More metallurgical processes. Glover sees additional educational opportunities arising as the program moves forward. 'We're making some upgrades to the facilities, just to have better teaching spaces, designated spaces where we don't have to deconflict research and teaching as much. We are getting a mill and a lathe so we can incorporate some machining into our program… Right now, they are mostly focused on casting. My background is actually in forging. For me, I would love to get more into the metalworking space.' Growing the program is also a focus for IACMI as well. 'We're going to continue to grow our network,' said Kubacki. 'We have a proposal out there that is not yet to be executed, but we're told soon that'll help us get eight to 10 more sites. … We also have Ohio State, and one of their deliverables is plans for a mobile foundry.' 'We're also trying to integrate the METAL program into our high schools,' added Harrell. 'We're doing one in Grange County here in Tennessee. We're integrating our place like a workshop where the kids will melt tin, they'll create a mold, they'll pour that, and we'll have some curriculum-building around that with the teachers there. We have a lot of outreach programs we're doing there to try to spark more interest in the metallurgical-type processes.' From her perch at Michigan Tech, Glover sees both the need for, and the tremendous opportunities that can arise from, programs like METAL. 'There's a ton of need for people to enter this workforce, a ton of opportunity to develop new technologies. Our factories and our forging houses and our metalworking spaces need to be modernized. They need a high level of investment over the next couple decades just to meet the manufacturing needs of this country. And that really hasn't been the case for a long time. So it's a really exciting time, and it's also a great area for employment. Michigan Tech grads have a super-high employment rate. I think that's true for engineering in general, and this is a great industry that has had a lot of hiring and continues to have a lot of hiring. And that's true both on the college side and on the trade side. You can make a really good career out of being a trades person in a metalworking space.'
Bloomberg
13 minutes ago
- Bloomberg
Musk Slams Trump Tax Bill, Again
Elon Musk has slammed the US Senate's version of President Donald Trump's tax bill for cutting tax credits for electric vehicles. Bloomberg's Max Chafkin talks about the impact that could have on Tesla with Caroline Hyde and Ed Ludlow on 'Bloomberg Tech.' (Source: Bloomberg)
