Latest news with #510(k
Business Wire
6 days ago
- Business
- Business Wire
Covita Health Partners Launches with a Mission to Make Expert Life Sciences Consulting More Accessible and Impactful
DENVER--(BUSINESS WIRE)-- Covita Health Partners, a newly launched regulatory and quality consulting firm, is proud to announce its entry into the life sciences industry by offering expert, affordable support to innovators developing medical devices, diagnostics, digital health technologies, combination products, human tissue-based therapies, and more. With a focus on accessibility, creativity, and measurable value, Covita is redefining what it means to be a consulting partner in today's dynamic healthcare environment. 'We started Covita because we saw talented teams and groundbreaking innovations stalling, not for lack of vision, but for lack of the right guidance at the right time." Founded to Fill a Critical Gap Covita Health Partners was founded in response to a growing and urgent need in the market. Life science innovators, especially early-stage teams, are being asked to do more with fewer resources, yet access to experienced, practical regulatory and quality support remains limited. Without that support, promising products face costly delays, missed opportunities, and in many cases, never reach the patients who need them most. 'In this industry, timing and execution are everything,' said Jeff Dupont, Chief Executive Officer and Co-Founder of Covita Health Partners. 'We started Covita because we saw talented teams and groundbreaking innovations stalling, not for lack of vision, but for lack of the right guidance at the right time.' The stakes are high: 75% of medical device startups fail, and the statistics are not much better in other segments of the life sciences. Covita Health Partners is committed to changing that. By providing smart, flexible support, and crafting creative, resource-conscious strategies, Covita helps innovators overcome early obstacles, accelerate development, and stay on a clear path to market. Industries Served and Services Offered Covita Health Partners supports clients across the life sciences spectrum, including: Medical Devices In Vitro Diagnostics (IVDs) Digital Health & AI-enabled technologies Combination Products Human Tissue-Based Products Reproductive Medicine Wellness Products and Supplements Its service offerings span the entire product lifecycle, some of which are listed below: Regulatory strategy and submissions (e.g., 510(k), De Novo, PMA, Q-Sub, CE marking, MDL) Quality management systems and ISO 13485 readiness Design control and risk management Software lifecycle and cybersecurity compliance Supplier qualification and management Audit readiness and inspection support (including PAI and ISO audits) Postmarket surveillance, complaint handling, and change control A True Partner, Not Just a Service Provider Unlike traditional consultants that offer one-size-fits-all services, Covita takes a tailored, hands-on approach. Its team engages as a true partner and scales support to match the client's stage and structure, and provides mentorship, training, and flexible solutions that grow with the organization. 'We're not just here to tick boxes,' said Dupont. 'We're here to solve problems creatively, teach as we go, and make sure our clients understand not only what they need to do, but why. That's how you build long-term success and foster long-term relationships.' Delivering Real, Measurable Value Covita's approach is designed to drive impact where it matters most. Clients benefit from: Faster time to market through proactive planning and targeted execution Reduced risk by staying ahead of regulatory requirements Smarter spending through right-sized systems and support Stronger investor confidence thanks to clear, executable strategies Empowered teams with increased internal capability and confidence Accessible Expertise for a Healthier Future Whether preparing for your first FDA submission, entering the EU market, or scaling operations after securing funding, Covita Health Partners brings clarity, experience, and creativity to the table, without the inflated cost or inflexibility of traditional firms. 'At Covita, we believe innovation shouldn't be held back by access to regulatory and quality support,' said Dupont. 'Our mission is to close that gap, so innovative medical products can reach the patients who need them.'
Yahoo
28-05-2025
- Business
- Yahoo
CEO maligns FDA delays over depression device treatments' US market entry
The CEO of Flow Neuroscience has called out the US Food and Drug Administration (FDA) for market entry delays for clinically validated devices for treating depression. The UK company's CEO pointed out that in spite of these delays, the US market is instead 'flooded' with wellness products that lack clinical validation and make 'vague' claims about their ability to 'improve focus' or relieve the symptoms of depression. Transcranial direct current stimulation (tDCS) devices such as the one developed by Flow, which gained a breakthrough device designation from the FDA in 2022, have been proposed as a new treatment in major depressive disorder (MDD). In a recent international clinical trial of Flow's device, the results of which were recently published in Nature Medicine, 57% of patients experienced remission from depressive symptoms and no severe side effects reported, while 92% of participants had a clinically significant response to the treatment. Despite the breakthrough designation, Flow remains unavailable in the US. 'People can easily purchase wellness devices with no clinical evidence behind them, while science-backed companies are still waiting on regulatory approval,' said Flow Neuroscience CEO Erin Lee. 'This kind of regulatory imbalance doesn't just hold back innovation, but ultimately harms patients.' Lee pointed out that the FDA system is 'fundamentally inconsistent' and called its approach 'two standards under one roof' given the FDA demands extensive US-based trials from devices that already meet international medical standards, yet at the same time, companies can 'flood the wellness category with unverified claims and no clinical scrutiny'. A recent whitepaper testifies to this gap. It found that 85-90% of medical devices in the US reach market via the 510(k) pathway, which doesn't require clinical trials, while novel neuromodulation devices like tDCs are typically pushed into De Novo or Premarket Approval routes, requiring multi-year trials even if they have existing international approval. Lee concluded: 'In practice, what this means is that people in Sweden, the UK, or even Hong Kong can access a device like Flow, while Americans are left with expensive gadgets that claim to stimulate the vagus nerve or boost brainwaves, without any evidence.' The FDA did not immediately respond to a request for comment. "CEO maligns FDA delays over depression device treatments' US market entry" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
06-05-2025
- Business
- Yahoo
Tariff-driven disruptions in regulatory compliance
Tariffs can have a significant indirect impact on regulatory compliance within the medical device industry, as any disruption in the components, materials or manufacturing processes used in these devices can trigger additional regulatory requirements, complicating the approval and post-market surveillance landscape. When tariffs are imposed on imported materials or components, manufacturers may be forced to adjust their supply chains, either by switching suppliers, modifying components or relocating production facilities. While these changes may be necessary to maintain cost efficiency, they often result in regulatory consequences. The US Food and Drug Administration requires that manufacturers submit new 510(k) notifications or supplements to existing approvals if there are significant modifications to a device's design, materials or manufacturing process. Even small changes in internal circuitry may require revalidation and regulatory resubmission, delaying product availability and increasing compliance costs. For example, for companies such as Medtronic in the diabetes care space, where 88.89% of diabetes care devices are wholly manufactured in the US, the immediate exposure to tariffs may be lower but the broader impact is still felt. Many components or raw materials may still be imported and subject to tariffs, creating potential bottlenecks and compliance triggers if alternatives are introduced. Companies operating internationally must also consider how such changes affect their regulatory obligations in multiple jurisdictions. An adjustment made in response to tariffs may require parallel filings with the European, Canadian or other global authorities. This multiplies administrative workload and extends timelines, diverting resources away from innovation and toward compliance maintenance. Abbott Laboratories offers a clear example of these tariff pressures. With key components of its FreeStyle Libre CGM system manufactured abroad, the company experienced cost hikes following US-China tariff escalations. In response, Abbott began exploring US-based production alternatives to mitigate trade exposure. However, this shift required regulatory revalidations and documentation updates for multiple global markets, straining internal compliance resources and delaying enhancements to its product pipeline. In essence, tariffs, though designed as economic tools, have ripple effects that extend deeply into the regulatory framework of the medical device sector. Maintaining compliance while navigating supply chain disruptions and evolving trade landscapes requires strategic agility. Balancing innovation, cost containment and regulatory integrity has become increasingly complex, particularly for multinational manufacturers striving to ensure uninterrupted access to life-sustaining technologies.
