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Home » Topics » Medical devices and technologies

Medical devices and technologies
Medical devices and technologies RSS Feed RSS

Sophia Lam, CEO, Mettactics

Mettactics in the process of raising money to empower precision medicine

June 23, 2023
By Doris Yu
As it develops a new metastasis-on-a-chip device based on microfluidic chip technology that provides a platform to capture and study highly metastatic cancer cells, Mettactics Ltd. is in the process of raising financing to develop its product to empower precision medicine. Founded in 2019, Hong Kong-based Mettactics developed a microfluidic device that can capture metastatic cells and carry out clinical tests to predict the drug response of patients based on the cells’ genetic signature.
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MHRA adopts device nomenclature system into device registration database

June 21, 2023
By Mark McCarty
The U.K. Medicine and Healthcare Products Regulatory Agency (MHRA) has moved to incorporate the Global Medical Device Nomenclature (GMDN) system into its device registration database, a development that will ease the task of providing postmarket surveillance for these products. However, the change may also take some of the noise out of the registration process in the U.K. market, thanks to the standardization of information the GMDN represents.
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Avita Recell device

Avita’s Recell gains FDA greenlight for skin repigmentation in vitiligo

June 21, 2023
By Tamra Sami
In its second approval this month from the U.S. FDA, Avita Medical Inc.’s Recell system received premarket approval for the repigmentation of stable depigmented vitiligo lesions. The approval marks the first therapeutic device offering a one-time treatment for vitiligo at the point of care. Using the device, a clinician prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas.
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Vanta device image

Medtronic presses physicians to revisit label instructions for Vanta during cardioversion

June 19, 2023
By Mark McCarty
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.
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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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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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Avenda Health’s Unfold AI

Avenda Health’s AI-powered prostate cancer mapping tool outperforms standard care in independent study

June 16, 2023
By Meg Bryant
Avenda Health Inc. reported new study results showing its Unfold AI platform, which uses artificial intelligence (AI) to map a tumor’s location within the prostate, encapsulates all of the clinically significant cancer present in the gland more effectively than standard care.
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Beyond Air Lungfit platform

Beyond Air breathes easier with $40M term loan

June 16, 2023
By Annette Boyle
Beyond Air Inc. completed a senior secured debt financing of up to $40 million from Avenue Capital Group to support the company’s commercial launch of the Lungfit PH and further development of the Lungfit platform. Beyond Air is focused on applications of nitric oxide for the treatment of patients with a range of respiratory conditions. Its affiliate, Beyond Cancer Ltd., is developing a treatment for solid tumors that uses an ultra-high concentration of nitric oxide.
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