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Home » Topics » Regulatory

Regulatory
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EPA’s proposal for ethylene oxide expected to drive smaller sterilizers out of the market

June 12, 2023
By Mark McCarty
The U.S. Environmental Protection Agency (EPA) has proposed a more stringent set of requirements for the use of ethylene oxide for sterilization of a variety of products, including medical devices, a proposal that is expected to increase the cost of operating these facilities.
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Senior eye exam

Medicare administrative contractors take dim view of several glaucoma technologies

June 12, 2023
By Mark McCarty
Beneficiaries in the U.S. Medicare program have access to several technologies and procedures for treatment of glaucoma, but Medicare administrative contractors (MACs) seem to be looking sideways at some of these offerings. Both Wisconsin Physician Services and Palmetto GBA have floated draft local coverage proposals that deem procedures such as goniotomy and the combination of canaloplasty and trabeculectomy to be investigational, suggesting that claims for these and other services and devices will not be paid by these MACs.
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Regulatory actions for June 12, 2023

June 12, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abeona, Anthos, Astellas, Astrazeneca, Crispr, Praxis, Sanofi, Vertex, Vor.
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US FDA adcom supports Leqembi for full approval

June 9, 2023
By Karen Carey
Eisai Co. Ltd. and Biogen Inc.’s Leqembi (lecanemab) gained the support of the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (adcom) in a 6-0 vote on June 9, as panel members unanimously agreed that the results of the phase III Clarity trial verified the clinical benefit in the treatment of Alzheimer’s disease. The FDA does not have to follow the adcom’s recommendation, but it often does. The PDUFA date for the supplemental NDA is July 6.
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Regulatory actions for June 9, 2023

June 9, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Foundation Medicine, Inspire Medical Systems.
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Health professional reviewing digital health data

FDA, industry coalition still at odds over September 2022 CDS final guidance

June 9, 2023
By Mark McCarty
The U.S. FDA’s September 2022 guidance for clinical decision support (CDS) software was controversial the moment the agency posted the document, prompting the filing of a citizen’s petition five months later. The CDS Coalition has penned a June 8 letter to FDA commissioner Robert Califf in an effort to draw a reaction from the agency, but the letter was accompanied by a summary of an analysis of CDS software with a machine learning (ML) component that suggests that such products that are in development may have to be reconsidered.
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Sonic DL imaging vs. conventional

FDA clears GE’s AI-powered Sonic DL for faster MRI

June 9, 2023
By Meg Bryant
GE Healthcare Technologies Inc. has launched Sonic DL, a deep learning technology designed to significantly accelerate magnetic resonance imaging (MRI) exams, after receiving regulatory clearance from the U.S. FDA.
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Pulse Medical’s non-invasive μFR system granted breakthrough device designation by FDA

June 9, 2023
By Doris Yu
Pulse Medical Technology Inc. obtained breakthrough device designation from the FDA for its fourth generation μFR system, which would accelerate the commercialization of the device. “The fourth generation μFR system is currently not available on the market, but Pulse Medical is preparing for the marketing approval of the product in the U.S.,” Jingfeng Han, director of science division at Pulse Medical, told BioWorld.
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Regulatory actions for June 9, 2023

June 9, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biogen, Eisai, Innate, Merck & Co., Novaliq, Pipeline, Rocket.
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Closest thing to an RSV vaccine gets adcom support

June 8, 2023
By Mari Serebrov
The U.S. FDA’s Antimicrobial Drugs Advisory Committee voted unanimously, 21-0, June 8 in support of Astrazeneca plc’s nirsevimab as a one-dose prophylactic for infants born during or entering their first respiratory syncytial virus (RSV) season.
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