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Home » Topics » Medical devices and technologies

Medical devices and technologies
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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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Medivis SurgicalAR

Medivis lands $20M for AR-guided surgical navigation platform

June 15, 2023
By Meg Bryant
Surgical care startup Medivis Inc. tallied $20 million in a series A financing led by Thrive Capital. The funds will be used to advance its 3D holographic clinical visualization system. Initialized Capital and Mayo Clinic also participated in the round, along with investors Bob Iger, Kevin Durant, Robert Spetzler, Hugo Barra and Coalition Operators. With the funding from the series A, Medivis has raised a total of roughly $25 million to date.
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Seracam, Serac's portable gamma imaging system

Serac begins studies for portable gamma imaging system

June 14, 2023
By Nuala Moran
Gamma imaging is about to move out of the centralized nuclear medicine department and to the point of care, with the start of a U.S. study of a portable device Seracam, under development by Serac Imaging Systems Ltd. The study, at Ohio State University, will compare the performance of Seracam to its larger, fixed, counterpart in imaging the same patients, on the same day.
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Boston Scientific's Ranger drug-coated balloon

Boston Sci’s Ranger DCB shows ‘best ever’ 3-year primary patency and 4-year freedom TLR

June 14, 2023
By Shani Alexander
Boston Scientific Corp. said that three-year primary patency and the four-year freedom from target lesion revascularization (TLR) rate for patients treated with the Ranger drug-coated balloon (DCB), in the Ranger II superficial femoral artery (SFA) study, are the best ever reported data for randomized trials using DCBs.
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Surmodics Inc.’s Pounce

FDA 510(k) clears the way for Surmodics to Pounce on expanded thrombectomy opportunity

June 14, 2023
By Annette Boyle
Surmodics Inc. is poised to jump on the market for below the knee thrombectomy now that its Pounce platform with a low-profile (LP) model has FDA 510(k) clearance. The system can now effectively clear organized clots from vessels as small as 2 mm in diameter. The Pounce LP expands the Eden Prairie, Minn.-based company’s “grab-go-flow” platform. In its first iteration, Pounce enabled removal of thrombi and emboli in peripheral arteries 3.5 mm to 6 mm in diameter.
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Tenor, Cardiorenal’s at-home blood potassium measuring device

FDA grants Cardiorenal breakthrough designation for home blood potassium device

June 13, 2023
By Bernard Banga
Cardiorenal SAS reported it has been granted a breakthrough device designation by the U.S. FDA for its Tenor at-home blood potassium measuring device. The Tenor smart device combines multiple technologies, app and cloud capabilities to assist patients with chronic kidney disease in measuring their blood potassium levels from home, obtaining results in under five minutes.
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Vivolta's Medispin platform

Vivolta raises €7M to expand automated medical electrospinning production system

June 13, 2023
By Shani Alexander
Vivolta BV raised €7 million ($US7.56 million) in new financing from existing shareholders and the Dutch government to expand its Medispin platform, an automated medical electrospinning production system, for high-throughput manufacturing of tubular electrospun products such as vascular stent grafts and prosthetic heart valves. The funds will also allow the company to continue to evolve into a medical electrospinning contract development and manufacturing organization as it transitions away from an equipment manufacturer.
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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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Biosency Bora platform

Biosency detects COPD exacerbations early thanks to predictive digital medical device

June 12, 2023
By Bernard Banga
Biosency SAS recently unveiled the latest results on its predictive digital medical device for remote monitoring of patient suffering from chronic obstructive pulmonary disease (COPD). The Bora platform demonstrated its ability to predict COPD exacerbation on average three days prior to hospitalization.
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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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