With the rates of nonalcoholic steatohepatitis (NASH) rapidly rising, Glympse Bio Inc. and Laboratory Corp. of America Holdings Inc. (Labcorp) have announced new tests that can assess the risk of the liver condition without the traditional biopsy.
U.S. FDA regulation of combination products has always been complicated, and a new final guidance takes up the long-standing controversy over FDA review of these applications. The final guidance makes explicit the possibility that the individual components of a cross-labeled combination product will be reviewed separately, a concession that industry saw as critical to ensure that these applications can make it through the FDA gauntlet without undue delay.
The quinquennial user fee process for medical devices has always proven controversial, but the FDA and industry have missed a Jan. 15 deadline for an agreement to be presented to Congress. Recently, several members of the House and Senate inked a letter to the FDA about the missed deadline, a signal that the agency’s aspirations for a $2.5 billion user fee deal are in jeopardy.
While comments continue to pour in, both in opposition and support, regarding the U.S. Centers for Medicare & Medicaid Services’ (CMS) proposed national coverage decision that would restrict Medicare coverage of monoclonal antibodies intended to treat Alzheimer’s to those used in CMS- or NIH-approved clinical trials, some groups also are appealing to Health and Human Services (HHS) Secretary Xavier Becerra to step into an HHS agency turf war.
Insulet Corp. received FDA clearance for its Omnipod 5 closed-loop automated insulin delivery (AID) system for patients aged six and older who have type 1 diabetes on Friday, Jan. 28, making it the first tubeless “artificial pancreas” system to get the FDA greenlight. The Omnipod 5 works with Dexcom Inc.’s widely used G6 continuous glucose monitor (CGM) to self-adjust insulin dosing using its Smartadjust algorithm.
Philips Respironics Inc., of Murrayville, Pa., was compelled to engage in multiple recalls over the use of a supplier’s polyester-based polyurethane (PE-PUR) sound abatement foam, and the latest victim of this problem is the company’s Trilogy Evo ventilator.
The semiconductor industry has been hit hard by shortages of computer central processing units (CPUs) in recent months, but the persistence of these shortages has prompted a new response from industry. The Advanced Medical Technology Association (AdvaMed) said device makers are taking steps to ease the crunch, but that the Biden administration must take steps to ensure that medical technologies do not suffer from shortages, given the critical role played by devices in patient care.
The U.S. FDA often has difficulty turning around draft guidances into final guidances in a timely manner, but that hasn’t impeded the agency’s appetite for fast turnaround of industry responses to FDA mandated postmarket surveillance studies. Nonetheless, the Medical Device Manufacturers Association (MDMA) said in comments to the docket for the May 2021 draft guidance for Section 522 postmarket surveillance studies that a requirement that such a study be fully enrolled within 24 months should be aspirational rather than compulsory.
Masimo Corp. managed to obtain and uphold an injunction against True Wearables Inc. regarding a pending patent application, which Masimo said would have disclosed a trade secret for pulse oximeters. However, the injunction is only a preliminary injunction, and thus the road ahead may ultimately yield a disclosure of a trade secret that Masimo has dedicated considerable resources to protect.
The U.S. Preventive Services Task Force (USPSTF) has once again broached the question of whether screening for atrial fibrillation (AF) in asymptomatic patients is a worthwhile exercise in public health, and once again the answer is “we don’t know.”
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