The second day of the U.S. FDA’s orthopedic devices advisory panel included a proposal to down-classify semi-constrained toe joint prostheses as class II devices, but the panel was adamant that such devices be slotted in class III, with one panelist referring to the literature for these devices as “garbage.” Read More

Medtronic plc is celebrating its latest win following the U.S. FDA’s approval of an early feasibility study (EFS) of the Intrepid transcatheter tricuspid valve replacement system in patients with severe, symptomatic tricuspid regurgitation. The action comes after the agency granted breakthrough device designation for the system. Read More

Minnetronix Medical Inc. has won the U.S. FDA’s nod for its Mindseye Expandable Port for neurosurgical procedures. The company touts the device as the first minimally invasive, retractable deep brain access system for use in the treatment of stroke, cancer and other conditions. Read More

The Lifetime Initiative released a roadmap to revolutionize health care in Europe by implementing cell-based interceptive medicine in a perspective article published Sept. 7 in Nature. Read More

A new type of SARS-CoV-2 antigen test that relies on single molecule array technology may be able to help clinicians identify which patients are most likely to experience severe disease. Read More

According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), drug-induced liver injury (DILI) is the leading cause of acute liver failure in the U.S. It is also a leading cause of drug failure in clinical trials. Now, researchers have used liver organoids to develop a polygenic risk score that could predict the risk of liver toxicity for multiple different drugs, regardless of the underlying mechanism. Read More

New hires and promotions in the med-tech industry, including: Discgenics, Entrinsic Biosciences, Medx Health, Sherlock Biosciences, Vitall Intelligence. Read More

Med-tech firms raising money in public or private financings, including: 10x Genomics, Acarix, Grail, Invacare, Nyxoah, Oncomfort, Recursion, Truepill. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alydia Health, BD, Dreamed Diabetes, Sight Sciences. Read More

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ambu, Analog Devices, A.R.C. Laser, Avricore Health, Benchmark Electronics, Change Healthcare, Clearside Biomedical, Coracoid Solutions, Coremap, D&D Pharmatech, Dnanudge, Evonetix, Fotona, Genova Diagnostics, Gogomeds, Hospitec, Joint Commission, Kit Check, Lifelabs, Livongo, Lncbio, Magellan Health, Medline Industries, Nanostring, Nanox, Orexo, Paradise Genomics, Parvizi Surgical Innovation, Personal Genome Diagnostics, Pharmigene, Regenexbio, Respiration, Rocky Mountain Analytical, S2 Genomics, Sca Pharma, Scrum, Spi Medical, Sqi Diagnostics, Thermo Fisher Scientific, Thrive Health, Thunderbio Science, Trendbio, Vizient. Read More

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alydia Health, Ka Imaging, Procisedx, Thermo Fisher Scientific. Read More

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Neuromatrix, Snyders Heart Valve, St. Jude Medical, Thermo Fisher Scientific. Read More

Keeping you up to date on recent developments in orthopedics, including: New drug shown to improve bone growth in children with achondroplasia; Failure to calibrate for ethnicity in fracture epidemiology would do more harm than good; Muscle aging: Stronger for longer; After Medicaid expansion, 'unmet need' for joint replacement surgery. Read More