“Show us your work” is basically the message the U.S. Court of Appeals for the Federal Circuit sent to the Patent Trial and Appeal Board (PTAB) when it vacated a decision by the board in an ex parte review of rejected patent claims submitted by Theripion Inc. While the Aug. 10 Federal Circuit opinion that remanded the case is nonprecedential, the appellate court made it clear that the PTAB must explain its reasoning for whatever conclusions it reaches.
Dermasensor Inc.’s elastic scattering spectroscopy device appears to have solved one of the more challenging issues in dermatology—early detection of skin cancers in individuals with darker skin tones. The device demonstrated very high sensitivity across all skin cancer types compared to histopathological exams with minimal variation between Fitzpatrick skin type groups in an analysis of the DERM-SUCCESS trial.
Developers of medical technology have many concerns about the U.S. Centers for Medicare & Medicaid Services’ (CMS) handling of coverage and reimbursement, but those controversies have typically revolved around process. A new report sponsored by industry steers a somewhat different tack, however, arguing that while there are issues of process, one key issue is that of funding, a problem that only Congress can remedy.
Venostent Inc. has completed $16 million in series A financing to support a U.S. pivotal trial for bioabsorbable wraps designed to improve outcomes for hemodialysis patients suffering from end-stage renal disease (ESRD). This comes after Venostent was granted an FDA investigational device exemption (IDE) to begin its U.S. Selfwrap-assisted arteriovenous fistula study and breakthrough device designation of its technology awarded last year.
Histoindex Pte Ltd.'s’s artificial intelligence (AI)-enabled tissue imaging technology more accurately measures the change in fibrosis than current pathology tests, the company said.
A complete response letter (CRL) from the U.S. FDA for GC-4419 (avasopasem) is causing Galera Therapeutics Inc. to dramatically change course to survive, with the company laying off about 70% of its workforce. That layoff, which will reach across several company departments, is designed to extend the cash runway into the second quarter of 2024. The adjustment comes after Galera expanded its commercial leadership in May to prep for a potential launch of avasopasem before the end of 2023.
A team from Siemens Medical Solutions Inc. presented a new artificial intelligence (AI) model that can predict people’s risk of multiple sclerosis (MS), at the 2023 American Association for Clinical Chemistry (AACC) annual scientific meeting in Anaheim, Calif.
It's one thing to ablate a lesion to treat a cardiac arrhythmia “but you can’t ablate the right place if you don’t know where it is,” said Nikki Sidi, U.S. President ofBiosense Webster Inc. Sidi was commenting on the July 24 U.S. launch of the high-density diagnostic Optrell mapping catheter with Trueref technology powered by its Carto 3 software.
The inter partes review (IPR) process used to adjudicate patent disputes in the U.S. has had its share of critics, but ongoing patent litigation revolving around nerve stimulation technology between Axonics Inc., and Medtronic plc has disclosed another bone of contention in how IPRs are handled. The Court of Appeals for the Federal Circuit has ruled that a patent holder, Dublin-based Medtronic in this instance, can offer a new claim construction for its disputed patent once an IPR has been instituted, but said also that the Patent Trial and Appeal Board (PTAB) had erred in not allowing Axonics to respond to the new claim construction, sending the related IPRs back to the PTAB for another look.
The accelerated clearance won by Johnson & Johnson (J&J) from the U.S. FDA for Talvey (talquetamab-tgvs) for relapsed or refractory multiple myeloma (r/r MM) in adults brings to the market the bispecific antibody that takes aim at G protein-coupled receptor class C group 5 member D, a target of interest to other developers as well.
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