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2023 Medtech Forum

Physicians the next audience for selling artificial intelligence in the EU

June 19, 2023
By Mark McCarty
Artificial intelligence (AI) faces a number of interesting hurdles in the EU, such as the still-developing Artificial Intelligence Act (AI Act), which seems destined to treat health care uses as high-risk propositions. Corinne Dive-Reclus, director of global lab insights at Roche Diagnostics, said there are possible solutions, such as overwriting the AI Act’s risk classifications with the risk category provided by existing regulations, but there is an open question as to whether a fix will be in place to prevent a potentially disastrous risk framework for AI in health care.
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Corneat Vision Ltd.’s Everpatch

Corneat aims to domesticate foreign body response with synthetic tissue

June 19, 2023
By Shani Alexander
The U.S FDA 510(k) clearance for Corneat Vision Ltd.’s Everpatch is a “safety stamp” for the product, and the “first step’ in the deployment of Corneat’s synthetic tissue substitute technology, which could displace the use of donor and processed tissue, Almog Aley-Raz, CEO of Corneat, told BioWorld. The Corneat Everpatch, for use in ophthalmic surgeries, is the first non-degradable material that seamlessly embeds itself with surrounding tissue avoiding foreign body response often triggered by implanted devices, Aley-Raz claimed.
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Sientra Allox2 Pro tissue expander

Sientra wins FDA clearance for next generation Allox2 Pro tissue expander

June 19, 2023
By David Godkin
Whoever said beauty is only skin deep hasn’t looked below to see what Sientra Inc. has made available there recently. The medical aesthetics company now boasts the only tissue expander cleared in the U.S. for exposure to magnetic resonance imaging, an important screening tool for breast reconstruction patients. Sientra’s CTO Denise Dajles told BioWorld the newly cleared Allox2 Pro Tissue Expander builds on the original expander also cleared by the FDA. “No other expander in the market has an MRI compatibility indication because they are based on a metal, i.e., metallic ports and big magnets in them,” Dajles explained.
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After yearlong break, OPDP sends new letter

June 16, 2023
By Mari Serebrov
In its first untitled letter in more than a year, the U.S. FDA’s Office of Prescription Drug Promotion (OPDP) took Xeris Biopharma Holdings Inc. to task for two webpages promoting the company’s Recorlev.
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Approval-stamp-blue.png
Biopharma regulatory actions and approvals May 2023

Two RSV vaccines among 19 US FDA approvals in May

June 16, 2023
By Amanda Lanier
The first five months of the year showed a slight increase in U.S. FDA approvals, though numbers are down compared to the previous four years. Worldwide approvals are down 16.67% through May, but up 5.42% compared to the previous seven years’ average.
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VRBPAC recommends monovalent vaccines targeting XBB for 2023-2024 COVID-19 campaign

June 16, 2023
The U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend COVID-19 vaccines for the 2023-2024 vaccination campaign be monovalent vaccines that target the XBB variants, currently the most prominent variants of the SARS-CoV-2 virus.
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Photomicrograph of diffuse large B-cell lymphoma

Genentech wins U.S. accelerated approval for lymphoma drug Columvi

June 16, 2023
By Karen Carey
Patients with an aggressive form of lymphoma who have failed prior therapies now have a new option for treatment with the U.S. FDA’s accelerated approval of Columvi (glofitamab-gxbm), which was granted under priority review a few weeks ahead of the July 1 PDUFA date.
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Regulatory actions for June 16, 2023

June 16, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Altamira, Anavex, Avenge, Biostar, Glycomimetics, Ipsen, Mabwell, Medexus, Mersana, NS, Seagen, Takeda, UCB.
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General Stim implanted sacral nerve stimulation system

General Stim’s implanted sacral nerve stimulation approved in China

June 16, 2023
By Doris Yu
General Stim Inc.’s implanted sacral nerve stimulation (SNS) system was approved in China to treat individuals with certain bladder and bowel conditions. Hangzhou-based General Stim’s SNS system consists of a sacral nerve stimulator, an extension lead and an electrode.
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SX-One device by Sonex Health

Sonex Health presses FDA to avoid down-classification of SX-One device

June 16, 2023
By Mark McCarty
The U.S. FDA’s citizen’s petition process doesn’t always yield the desired outcome, but the agency must nonetheless respond to these petitions. Sonex Health Inc., has petitioned the FDA to rethink a proposal to reclassify the company’s SX-One device for treatment of carpal tunnel syndrome, an unusual instance in which a medical device maker has resisted a proposal to make a device exempt from regulatory requirements.
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