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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

June 19, 2023

View Archived Issues
Sientra Allox2 Pro tissue expander

Sientra wins FDA clearance for next generation Allox2 Pro tissue expander

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. Read More
Corneat Vision Ltd.’s Everpatch

Corneat aims to domesticate foreign body response with synthetic tissue

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. Read More
Bioactive glass

Silver-infused glass improves wound healing

Saturating bioactive glass with silver sustains the metal’s antimicrobial properties and reduces biofilm formation, researchers at the University of Birmingham, U.K., found. Their study, published in Biofilm, demonstrated that specific preparation, storage and application techniques minimize the transformation of silver ions to silver chloride that typically reduces silver’s healing properties over time. Read More

Physicians the next audience for selling artificial intelligence in the EU

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. Read More
Vanta device image

Medtronic presses physicians to revisit label instructions for Vanta during cardioversion

The Vanta device by Medtronic plc, provides relief from pain for thousands of patients, but the Vanta might also feel the pain when the patient is undergoing cardioversion. According to a field safety notice from Dublin-based Medtronic, two patients in Europe have undergone explant procedures for the device due to damage sustained during cardioversion, but the company urges physicians to pay heed to the labeled indication, which recommends that the device be temporarily reprogrammed to reduce the risk of damage to the device, an action that Medtronic indicated should ward off any such issues. Read More

Med-tech gainers and losers for June 12-16, 2023

The top 10 med-tech stock gainers and losers for the week. Read More

Appointments and advancements for June 19, 2023

New hires and promotions in the med-tech industry, including: Northstar. Read More

Financings for June 19, 2023

Med-tech firms raising money in public or private financings, including: Adicon. Read More

In the clinic for June 19, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Hangzhou Valgen. Read More

Other news to note for June 19, 2023

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Sqi Diagnostics. Read More

Regulatory actions for June 19, 2023

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avita Medical. Read More

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