Pattern Computer Inc.'s test for SARS-CoV-2 infection gives new meaning to rapid results. Taking 15 seconds from start to result, the test offers balanced accuracy of better than 96%, according to the company. The test is also not dependent on timing, unlike current antibody tests, and takes less time than point-of-care PCR tests. Its light-based system creates patterns based on a saliva sample, which is then matched against a previously developed model.
The FDA’s device center recently updated its guidance for testing and labeling of devices for compatibility with magnetic resonance (MR) fields. Some items, such as orthopedic plates and screws, might not have been evaluated for compatibility up to now. The FDA’s Sunder Rajan said that existing 510(k) and PMA devices are grandfathered in under the legacy policy, but that all implants will have to be evaluated for MRI compatibility going forward, even devices not previously subject to testing.
There is “a wide gap” in the availability of pediatric medical devices that suggest most of these were developed for adolescents, according to a new study on FDA premarket approval applications (PMAs). The findings stem from an evaluation of 297 PMA documents for 149 high-risk devices, 68% of which include pediatric age indications. Pediatric medical devices have lagged behind their adult counterparts in terms of availability, options and innovation. The new findings add to the current relatively limited body of research considering the ample medical device space but are consistent with previous findings that most devices indicated for children are limited to those over 18 years of age.
The follow-up to the U.S. 21st Century Cures Act, dubbed Cures 2.0, encodes several anticipated features such as a Medicare coverage mechanism for breakthrough devices and the Advanced Research Projects Agency for Health (ARPA-H). Less expected was a provision for the use of real-world evidence in evaluation of the safety and effectiveness of drugs and biologics after FDA approval, a provision that could prove useful in post-approval evaluations of products such as Biogen’s Aduhelm.
The FDA and industry are deep into the negotiations over the next device user fee, with the usual array of concerns such as premarket program performance and the volume of user fees. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), has once again given voice to a perceived need for a significant boost in user fee volumes in an interview with a major trade association, suggesting that device makers can expect a significant uptick in fees for PMAs and 510(k)s in the years ahead.
In a split decision delivered June 21, the U.S. Supreme Court resolved the dilemma created by the constitutional non-reviewability of decisions rendered by the Patent Trial and Appeal Board (PTAB). The Supreme Court’s solution is to make those PTAB decisions reviewable by the director of the Patent and Trademark Office (PTO), although the PTO director’s discretion regarding which PTAB cases should be reviewed may itself prove highly controversial in the months and years to come.
In denying cert to Abbvie Inc. v. FTC June 21, the U.S. Supreme Court may have strengthened an FTC tool for going after biopharma companies that try to protect their patents. The high court’s refusal to hear the case reinforces a September decision by the U.S. Court of Appeals for the Third Circuit that the biopharma industry has said will make it more difficult for drug companies to pursue patent infringement cases in keeping with Hatch-Waxman.
The U.S. Supreme Court will not take up Amarin Corp. plc’s appeal of a September Federal Circuit decision that opened the door for generics of the company’s fish oil-derived cardiovascular drug, Vascepa (icosapent ethyl), to enter the U.S. market.
A new FDA discussion paper addresses cybersecurity issues specific to the servicing of medical devices, with the goal of guiding the conversation about potential challenges and opportunities. It coincides with a larger agency initiative to provide more clarity on servicing.
The June report to Congress by the Medicare Payment Advisory Commission (MedPAC) encodes several suggestions as to how rates would be determined under the Medicare clinical lab fee schedule (CLFS), such as the use of competitive bidding for laboratory tests. That and other policy concepts earned a quick reply by the American Clinical Laboratory Association (ACLA), which said that bidding and other concepts either repeat the mistakes of recent history or fail to account for the prospect that these mechanisms could impose artificially low rates for tests and ultimately hamper patient access.
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