Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Eyenovia, Happe Spine, Neuronetics.
Citing significant concerns of bacterial contamination, the FDA urged consumers and health care providers to stop using specific lots of SD Biosensor Inc.’s Pilot COVID-19 At-Home Tests, which were distributed by Roche Diagnostics Systems Inc. The agency warned that direct contact with the contaminated liquid solution could pose safety issues as well as impair the test’s performance.
Anhui Happiness Workshop Medical Equipment Co. Ltd.'s single use ureteroscope was approved by China’s NMPA, becoming the first domestically developed electronic soft ureteroscope to monitor intrarenal pressure during procedures.
Even though COVID-19 is transitioning from pandemic to endemic across the world, it will remain first in mind as U.S. lawmakers look to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA) this year to ensure the country is better prepared for future threats. With a Sept. 30 deadline for reauthorizing PAHPA, the Senate Health, Education, Labor and Pensions (HELP) Committee has its work cut out for it. But it won’t be starting from scratch. In opening a May 4 hearing on the reauthorization, HELP Chair Bernie Sanders (I-Vt.) said the committee would build on the efforts started last year under then-Chair Patty Murray (D-Wash.) and now-retired Ranking Member Richard Burr (R-N.C.).
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cumulus Neuroscience, Norlase, Nucleix.
With the COVID-19 public health emergency ending in the U.S. next week, Congress is looking to use the lessons learned from the pandemic to draft a new iteration of the Pandemic and All-Hazards Preparedness Act to ensure the country is better prepared for the next pandemic.
The FDA gave the greenlight to Route 92 Medical Inc. for its Freeclimb 70 reperfusion system in the treatment of ischemic stroke. The 510(k) clearance includes a Freeclimb 70 aspiration catheter, as well as a Tenzing 7 delivery catheter.
Med-tech companies often use robotics and artificial intelligence (AI) to transform healthcare systems and improve patient outcomes. However, the current hype around generative AI, such as ChatGPT, and the explosion in the use of data are raising questions around regulation, reimbursement, and whether AI and robotics are the right tools for certain jobs, participants heard at the LSX World Congress in London.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cognixion, Formus Labs, Foundation Medicine.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Centricity Vision, Femasys.