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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more
On April 15, 2025, Canada’s Drug Agency (CDA) released its new five-year strategic plan, Insight to Impact 2025-2030. Formerly the Canadian Agency for Drugs and Technologies in Health (CADTH), this is the CDA’s first...more
Recorded at SCbio’s 2025 annual conference, Heather and Matthew welcome back Kimberlee Steele of SHL Medical, a global leader in medical technology design and manufacturingw. After first joining us six months ago, Kimberlee...more
What if the key to understanding and improving brain health lies in a breakthrough approach to neurodata? For Rob Cooley, founder and CEO of Nuream, unlocking the potential of brainwave data has the power to transform...more
To help you stay on top of the latest news, our AI practice group has compiled a roundup of the developments we are following....more
What if the key to advancing brain health and neuroscience lies in harnessing neurodata in ways never thought possible? On today’s episode of Founder Shares, Robert S. Cooley Jr., founder and CEO of Nuream, discusses how his...more
A recent report by Precedence Research estimates the global market size for implantable medical devices will grow from USD 97.62 Billion in 2024 to USD 178.15 Billion by 2034: The rapid increase in the global market size of...more
A New Hope in Kidney Transplants: The Promise of Xenotransplantation - Joe’s struggle for a kidney transplant highlights a dire reality: donor shortages are leaving countless patients in limbo. Enter Dr. PK, a pioneering...more
The 2025 SCOPE Conference (Summit for Clinical Ops Executives), held last week in Orlando, FL, brought together more than 4,500 industry leaders, innovators, and experts in the clinical operations field. ...more
Medtech mergers and acquisitions (M&A) and venture capital (VC) showed signs of life in 2024, contributing to an overall optimistic outlook for the sector this year despite lingering headwinds. Strategic investments are...more
Every year, 12,000 leaders in the healthcare industry meet at HLTH. This year's conference covered all aspects of the healthcare ecosystem, and here are the nine that we should watch as we enter the new year....more
As the New Year begins, questions surrounding how recent election results will impact technology regulation across industries loom large. It’s hardly a bold prediction that artificial intelligence (“AI”) and the regulation...more
Surgimatix, our client spotlight this month, developed what can only be called a novel solution. Surgimatix is an early-stage medical device company pioneering the first proprietary laparoscopic device that delivers...more
As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more
Last week, the U.S. Food and Drug Administration (FDA) finalized guidance on the types of information that should be included in a Predetermined Change Control Plan (PCCP) as part of a marketing submission for an artificial...more
For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical device submissions....more
Investment in artificial intelligence (AI) is rising fast. The International Data Corporation projects global spending on AI R&D will reach $632 billion by 2028, more than twice the expected total for 2024....more
Welcome to our eighth 2024 issue of Decoded - our technology law insights e-newsletter. Thank you for reading. EU AI Act Tightens Grip on High-Risk AI Systems: Five Critical Questions for U.S. Companies - Why this is...more
Generative AI is converging with every sector – and health care is no exception. With it, companies should keep up with the array of laws and regulations – existing and envisioned – that govern its use. Read on for highlights...more
On August 5, 2024, FDA’s Center for Devices and Radiological Health (CDRH) published a discussion paper entitled, “Discussion Paper: Health Equity For Medical Devices” (Discussion Paper), to aid in its efforts to advance...more
This week, Heather and Lauren welcome Kimberlee Steele, the Managing Director for North America of SHL Medical, a world leader in the design, development, and manufacture of autoinjectors, pen injectors, and drug delivery...more
Episode 8: Innovation in Spine Health In this episode of BRight Minds in Healthcare Delivery, Eric J. Muehlbauer joins host Eric Tower for a conversation about his storied career at the North American Spine Society...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more
During this session, McDermott Partner Kristian Werling and Jeff Smith, a senior partner at McKinsey & Company, shared insights across the pharma and MedTech services industries, including key trends and opportunities shaping...more
The European Union has introduced comprehensive regulations for artificial intelligence (AI) systems, encapsulated in the EU AI Act (AI Act). The objective of the AI Act is to ensure that AI systems in the EU are safe,...more