The FDA plans to expand generative AI capabilities—across all centers using a secure, unified platform.
Angioplasty and stenting procedures (or percutaneous coronary interventions/PCIs) are performed more than four million times around the world every year to open up blockages in coronary arteries to allow the heart to receive proper blood flow. Most of these procedures — 80-85 percent — are only guided by traditional angiography, an x-ray of the blood vessels that requires a contrast agent to be flushed into the heart to identify where the blockages are.
As healthcare pushes forward in digital transformation, AI has emerged as a critical tool in optimizing electronic medical records. EMRs remain both vital and frustrating. Clinicians wrestle with usability, while patients struggle with engagement and access. By integrating AI thoughtfully and securely, we can create a more intuitive, efficient and user-centric experience for both groups.
The industry’s heavy reliance on waterfall project management has resulted in long, siloed, and high-risk product development cycles. This model does not accommodate evolving regulations, shifting geopolitical realities, or fast-changing healthcare needs.
Black Book’s ad hoc survey of 200 healthcare executives reveals real-time disruptions, cost inflation, and stalled innovation as Trump-era tariffs expand across key healthcare imports.
Industry groups hoping to lessen impacts of Donald Trump’s “Liberation Day” plans on medical products and MedTech development sent letter to the U.S. Trade Representative.
Under IVDR, clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers seeking CE Marking and global market access. With updated compliance deadlines approaching, how can manufacturers manage risk and avoid regulatory delays and disruptions in their market strategies?
Clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers seeking CE Marking and global market access. With IVDR compliance deadlines approaching, how can manufacturers manage risk and avoid regulatory delays and disruptions in their market strategies?
Solventum purification and filtration portfolio expected to be highly complementary with Thermo Fisher’s bioproduction business, strengthening the company in the high growth bioprocessing market.
Teleflex to create a new, independent publicly traded company consisting of its Urology, Acute Care, and OEM businesses. Remaining units and recently announced acquisition expected to remain.
