The U.S. FDA has several years of experience with computational modeling (CM) for medical device design and testing; however, the movement toward a policy has wanted for a solid body of data on which to base a guidance.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ac Immune, Alliance Family of Companies, Applied DNA Sciences, Battelle, Caretaker Medical, Cerner, Clinical Laserthermia Systems, Columbia University, DNA Labs International, Freedom Innovations, Haliodx, Induction, Medalliance, OSU Wexner Medical Center, Osmind, Ottobock, Pacific Edge, Paltown Development Foundation Proteor, Providence, Southwest Labs, Stratus, Tegria, Thermo Fisher Scientific, Votis.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cartiheal, GE Healthcare, Varian.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: ICER cost models going global; Canada prepares for ICH Q12; HHS partners on Lyme innovation; AMA adds codes for COVID-influenza testing; MedPAC concerned about post-pandemic telehealth; CMS: CLIA audits yield cease-and-desist letters.
Keeping you up to date on recent developments in cardiology, including: Complications in pregnancy tied to increased risk of heart disease, stroke later on; Creating an artificial vessel; Hearts in space!
Belong.Life has expanded its digital clinical trial matching program to include patients with multiple sclerosis (MS). The technology uses advanced artificial intelligence (AI) that processes a patient's medical data and determines which trials in its global database are appropriate. The app typically returns results, which are prescreened by a clinical trial coordinator, in less than two days. More than 8,000 cancer patients have used the program so far.
PARIS – Bonetag SAS, of Perpignan, France, is developing a universal medical device designed to ensure in vivo traceability for orthopedic knee replacements.
Several senior managers at the Center for Devices and Radiological Health (CDRH) have been pushing the convergence between U.S. FDA and international quality systems standards, often with the claim that the two standards already are nearly completely aligned. However, Jack Garvey, CEO of Compliance Architects LLC, ran through a side-by-side comparison of ISO 13485 and Part 820 and maintained that the two standards are too conceptually and textually different to plausibly assert that they are 95% harmonized.
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