The U.S. FDA has granted 510(k) clearance to GE Healthcare Technologies Inc. for its Precision DL for PET/CT, an artificial intelligence (AI) and deep learning (DL)-powered software designed to sharpen quality and improve efficiencies in medical imaging. Part of the company’s Effortless Recon DL portfolio, the technology is available on GE’s Omni Legend PET/CT digital scanner.

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.).

After receiving a U.S. FDA complete response letter nearly two years ago, Cyclopharm Ltd. said the agency has accepted its response and reset the clock for the NDA review of its Technegas combination product for pulmonary embolisms, with a new PDUFA date set for Sept. 29.

The success of the President’s Emergency Plan for AIDS Relief (PEPFAR) over the past 20 years is one of the biggest challenges in reaching its goal of eliminating HIV as a global public health threat by 2030, members of the U.S. Senate Foreign Relations Committee were told as they moved toward reauthorizing the program for another five years.

The possibilities of cures for cancer and other tough-to-treat diseases and the ability to further personalize medicine are creating a lot of excitement about the future of radiopharmaceuticals as both therapy and diagnostics. To reach that future, industry and researchers will have to overcome a lot of challenges, not the least of which stem from the multiple government agencies involved in regulating the source material, development, distribution and use of radioactive drugs and devices.

Global interest in radiopharmaceuticals is growing, and some big deals in the space have sparked interest in the last few years. Novartis AG has spent about $6 billion in acquisitions and is seen as the global leader.

The U.S. Federal Trade Commission (FTC) issued a final order in connection with the proposed reacquisition of Grail Inc. by Illumina Inc., in an action that might seem to finally conclude a matter that has stretched over several years. However, the FTC acknowledged that Illumina has 60 days to petition the order, which Illumina said it intends to do in conjunction with an effort to overturn a similarly adverse outcome in the EU.

Ixlayer Inc. expanded access to diabetes screening by offering its test via retailers, health systems and payers, making it easier for consumers to measure and track their blood glucose levels without requiring a doctor’s visit or prescription. If an individual’s test results indicate that they have or are at risk of developing diabetes, however, the company will offer to connect them with a health care provider available through the reseller’s network to discuss next steps.

Genialis Inc. reeled in $13 million in a series A financing co-led by Taiwania Capital and Debiopharm Innovation Fund. The funds will be used to build out the company’s store of clinically validated biomarker models for individualized cancer diagnosis.