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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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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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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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Elderly woman holding illustration of brain with missing puzzle piece

As diagnostics advance, Parkinson’s sector waits for better therapy

June 8, 2023
By Randy Osborne
Standing as one of the more prominent among incurable conditions, Parkinson’s disease (PD) still hasn’t met a medicine or surgical intervention that can slow or stop progression, despite efforts of many drug developers testing new strategies.
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USoP device being worn on chest

UCSD engineers develop ultrasound, deep tissue monitoring device

June 8, 2023
By David Godkin
They call it the world's “first fully integrated wearable” ultrasound system for evaluating cardiovascular function while you walk, run, even ride a bicycle. Built on the nanoengineering research at the University of California San Diego (UCSD) the wearable ultrasonic system-on-patch (USoP) employs machine learning to interpret deep tissue vital signs data and track subjects in motion.
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Telehealth Expansion Act passes first hurdle in US House Ways and Means

June 8, 2023
By Mark McCarty

Proponents of telehealth have been pressing Congress to statutorily broaden coverage of telehealth since before the COVID-19 pandemic, and the Telehealth Expansion Act of 2023 carries the weight of at least some of these expectations. The House Ways and Means Committee’s health subcommittee recently voted 30-12 to pass along the legislation to the full committee, but the bill operates principally to allow high-deductible health plans to cover telehealth benefits before the enrollee has met the deductible, leaving a substantial amount of telehealth terrain unaddressed.


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Avita Recell device

FDA approval gives Avita’s Recell room for healthy growth

June 8, 2023
By Annette Boyle
The U.S. FDA granted premarket approval to Avita Medical Inc.’s Recell system for a wide range of full-thickness skin defects, potentially quintupling the company’s market opportunity. Recell is a cell harvesting device that produces and delivers a regenerative cell suspension using a small sample of the patient’s own skin. The Spray-On Skin cells, previously approved for use in severe burns, stimulate healing and repigmentation. “This is a landmark approval representing an inflection point for Avita Medical,” said Avita CEO Jim Corbett. “The FDA approval now offers surgeons a best-in-class treatment option for a multitude of severe wounds within inpatient and outpatient settings.”
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Powered wheelchair in hallway

US Medicare program renders ‘landmark’ coverage memo for seat elevation devices

June 7, 2023
By Mark McCarty
The U.S. CMS has wrapped up a coverage analysis for seat elevation systems that are accessories for power wheelchairs, but the agency went above and beyond the strict terms laid out in the proposed decision memo.
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FDA warning letters hint that med-tech compliance programs drifted during COVID

June 7, 2023
By Mark McCarty
The U.S.FDA posted two warning letters to medical device manufacturers June 6, one each to Irhythm Technologies Inc., and Steiner Biotechnology LLC, and both warnings include citations for marketing for claims that are not in the FDA-reviewed product labels.
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