The FDA’s quarterly report on device user fee performance goals encodes a number of metrics, such as the rate at which PMA originals are cited for a major deficiency on the first review cycle. For premarket approval applications (PMAs) filed in fiscal year 2021 to date, the major deficiency rate on the first cycle is 86%, which would be tied for the fifth highest rate in two decades if that rate holds throughout the balance of the fiscal year.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insightrx, Ortho Clinical, Pillar, Zoll.
Citing a surge in merger filings, the U.S. Federal Trade Commission (FTC) said it is adjusting its process for reviewing mergers, which means more mergers may be reviewed retroactively.
For the first time ever, Canada will be granting patent term adjustments beginning in January. That’s welcome news for the biopharmaceutical and med-tech industries, and it’s long overdue, Jeffrey Morton, a partner at Snell & Wilmer LLP, told BioWorld.
The U.K.’s National Institute for Health and Care Excellence (NICE) is playing catch-up after seeing its workflow disrupted by the COVID-19 pandemic and has made the first funding approval using a new fast track appraisal process.
For the second time in less than 30 days, a company indirectly acquired by Abbott has settled with the U.S. government over alleged violations of the False Claims Act (FCA). In this instance, the now-defunct Arriva Medical LLC and its parent company Alere Inc. have agreed to pay $160 million to settle allegations that Arriva caused false Medicare claims to be filed for glucometers.
Abbott Laboratories has secured FDA clearance for its latest optical coherence tomography (OCT) imaging platform powered by the company’s new Ultreon software. The artificial intelligence (AI)-powered imaging software allows doctors to view coronary blood flow and blockages more clearly, aiding in care management and treatment decisions.
The annual scramble for elevated payment rates under the U.S. Medicare inpatient rule has concluded, and at least one artificial intelligence product came up short in its bid for a new technology add-on (NTAP) payment. However, Medtronic plc, Boston Scientific Corp. and Cook Medical Inc. all secured or sustained NTAP payments for products that are critical for patients with a variety of life-threatening conditions, such as severe pulmonary valve regurgitation in pediatric patients.
PERTH, Australia – In a possible world-first decision, an Australian court has ruled that artificial intelligence can be named as the inventor of a patent. Federal Court Justice Jonathan Beach ruled in Thaler v. Commissioner of Patents that under Australian patent law, inventors don’t necessarily have to be human.