CardioRenal Systems wins FDA breakthrough nod for RenalGuard Therapy device

[Image courtesy of CardioRenal Systems]CardioRenal Systems announced today that it received FDA breakthrough device designation for its RenalGuard Therapy device.

Milford, Massachusetts-based CardioRenal Systems designed the device for preventing acute kidney injury (AKI). It’s for patients at risk for cardiac surgery-associated AKI.

RenalGuard protects the kidneys with personalized, active hydration. The system maximizes urine output while balancing hydration. It does so through real-time urine output monitoring and IV infusion in a smart re-hydration system.

Results from the company’s KIDNEY study produced positive results for RenalGuard. CardioRenal Systems said the device demonstrated a 52% reduction in AKI compared to standard of care. The company evaluated it in a 220-patient, randomized, controlled clinical trial.

“We are thrilled to receive the breakthrough device designation and appreciate all the hard work that our team pu…

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Able Medical launches Valkyrie looped sternotomy sutures

[Image courtesy of Able Medical Devices]Able Medical Devices announced today that it launched its Valkyrie looped sternotomy sutures for use after open heart surgery.

Marquette, Michigan-based Able Medical designed the stainless steel sutures to close a patient’s chest after open heart surgery. Compared to traditional wire sutures, Valkyrie doubles the surface area of single wires and provides a more robust sternal closure.

The sutures also come fitted with three different needle configurations and in two different sizes (48mm and 55mm).

“We are thrilled to offer another integral part to sternal closure at an affordable price to hospitals,” said Peter Didyk, managing director of Able Medical. “Offering high-quality sutures at low prices is a win for patients and healthcare providers alike.”

Able Medical’s Valkyrie sutures can work in conjunction with its Valkyrie thoracic fixation system. It stabilizes and fixates the fractures of the che…

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Getinge launches new ventilator

The Servo-c ventilator. [Image courtesy of Getinge]Getinge this week launched its new Servo-c mechanical ventilator that offers lung-protective therapeutic tools for pediatric and adult patients.

The company aims for Servo-c to make healthcare accessible and affordable for more hospitals, according to a news release. Its design simplifies respiratory support, Getinge said.

“Lung protection challenges come in many shapes and sizes,” said Getinge President of Acute Care Therapies Elin Frostehav. “That is why Servo-c is designed for safe, easy and efficient use that enables personalized respiratory treatments. With the essential functionalities provided, it is ideal for hospitals in the targeted markets looking for a high acuity ventilator at an affordable price point.”

Servo-c uses modular component parts to enable smart fleet management. This ensures uptime and drives down costs without the need of proprietary disposables.

Other feat…

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FDA extends shelf life of some popular COVID tests

[Image courtesy of Abbott]The FDA announced today that certain COVID-19 diagnostic tests under emergency use authorization now have a longer shelf life.

Diagnostics made by Abbott, Maxim Biomedical and iHealth Labs all received extensions for their expiration dates.

The Abbott BinaxNow COVID-19 antigen self tests now have a shelf life of 22 months. Previously, the popular test had a 15-month shelf life.

Maxim Biomedical’s ClearDetect COVID-19 antigen home test initially received authorization with an eight-month shelf life. The FDA announced that it extended the shelf life of that test to 12 months.

iHealth Labs COVID-19 antigen rapid tests received a three-month extension from 12 months to 15 months.

“The expiration dates for these tests have been extended to reflect the longer shelf-life,” the FDA said in a notice. The agency based its extension on additional data provided by the manufacturers. This data demons…

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Novocure announces leadership team restructuring

Novocure (Nasdaq:NVCR) today announced organizational changes for its leadership team as it prepares for future growth.

The company said the changes became effective Jan. 17.

Pritesh Shah, Novocure’s chief commercial officer, transitioned into a new role as chief growth officer. His responsibilities include product and portfolio strategy, brand management, launch framework and market access/intelligence. He also holds responsibility for new indications in the U.S.

Dr. Ely Benaim, chief medical officer, stepped down from his role and departed the company. He will partner with Novocure’s executive leadership team to ensure a smooth transition. Dr. Piet Hinoul, currently SVP and head of global medical affairs, takes over in an interim role to ensure business continuity.

Novocure chief science officer Dr. Uri Weinberg now becomes chief innovation officer. His new position includes expanding the potential of the company’s tumor-treati…

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Surmodics announces regulatory delay for its SurVeil balloon
The FDA noted more information on biocompatibility and labeling is needed.

The FDA has indicated that Surmodics’ Surveil drug-coated balloon premarket approval application is not approvable.

According to an FDA letter to the company, Surmodics’ Surveil was not approved due to certain information in the biocompatibility and labeling categories. The governing agency said more information needs to be added by an amendment to Surmodics’ PMA application to place it in an approvable form.

Needham analyst Mike Matson said in an email that company management anticipated approval in the first quarter of 2023 to trigger a $27 million milestone payment from Abbott, $25 million of which would be considered revenue.

Get the full story on our sister site, Medical Tubing + Extrusion.

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SetPoint Medical raises $80M for nerve stimulation tech that treats autoimmune disease

[Image from the SetPoint Medical website]Autoimmune disease treatment developer SetPoint Medical announced today that it raised $80 million in a preferred stock financing.

Valencia, California-based SetPoint Medical develops a novel platform for treating chronic, inflammation-mediated autoimmune diseases. Its initial focus centers around a potentially less immunosuppressive option for treating rheumatoid arthritis (RA).

New investors Norwest Venture Partners and Viking Global Investors co-led the preferred stock financing. New investor Gilmartin Capital also participated.

Returning investors New Enterprise Associates (NEA), Action Potential Venture Capital, Boston Scientific, Topspin Fund, Euclidean Capital, Morgenthaler Ventures, Richard King Mellon Foundation, ShangBay Capital, Ascendum Capital, Catalio Capital Management, Midas Capital, Citta Capital, SVE Capital, and an undisclosed strategic investor all participated.

“We are thrilled to secure a…

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Medtronic signs pledge to advance health equity

Medtronic (NYSE:MDT) today announced that it joined the Global Health Equity Network (GHEN) to drive change in health equity.

GHEN, a World Economic Forum, brings together the private and public sectors to address health equity issues. CEOs and business leaders comprise the forum focused on prioritizing action in organizational strategy and purpose.

“Addressing health equity is critical because more than half the world’s population lacks access to essential healthcare,” Medtronic said in a news release. “And the most challenging health issues disproportionately impact marginalized populations. But we recognize that no one solution or organization can achieve health equity alone; strategic partnerships are essential to accelerating this critical work.”

As part of the GHEN agenda, Medtronic signed the Zero Health Gaps Pledge. This pledge addresses progress in health equity across 10 areas. Committed organizations agreed to help driv…

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Akili lays off 46 workers

A child uses the EndeavorRx digital therapeutic. [Image courtesy of Akili]Akili announced that its board of directors approved an operating plan for 2023 that includes a 30% workforce reduction.

The Boston-based digital therapeutic developer’s reduction reaches across different areas and functions. In total, 30% of Akili’s workforce amounts to 46 employees. The company communicated the decision to employees on Jan. 12 and expects to complete the reduction by the end of the first quarter.

Get the full story at our sister site, Drug Delivery Business News.

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Ra Medical realigns board of directors following merger

Ra Medical Systems (NYSE:RMED) this week announced the realignment of its board of directors in conjunction with the recently announced merger with Catheter Precision.

David Jenkins joins the board as executive chair, and James Caruso will serve as a director. Martin Colombatto, Will McGuire and Susann Meline will serve as directors. Additionally, directors Joan Stafslien and Richard Mejia have resigned.

Get the full story on our sister site, Medical Tubing + Extrusion.

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Bayer makes radiology play with Blackford Analysis acquisition

Bayer announced today that it acquired AI imaging provider Blackford Analysis as it looks to drive innovation in radiology.

The company said in a news release that its strategy includes developing and adopting AI within the clinical workflow. It aims to improve patient care and advance its position in digital medical imaging.

Blackford has a presence in both the U.S. and United Kingdom. It develops a clinical application ecosystem focused on imaging and analytics.

“Adding Blackford and its AI technology to our radiology portfolio secures Bayer an excellent position in the fastest growing segment within the overall global radiology industry,” said Stefan Oelrich, member of the board of management, Bayer AG and President of Bayer’s Pharmaceutical Division. “This acquisition complements our comprehensive radiology portfolio and nourishes our engagement to drive innovation in digital health. We are pleased to join forces with Blackford and their exceptional …

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FDA clears new sepsis diagnostic from Cytovale

The Cytovale System on which the IntelliSep diagnostic is run. [Image from Cytovale’s website]Cytovale announced today that it received FDA 510(k) clearance for its IntelliSep test for the early detection of sepsis.

San Francisco-based Cytovale designed IntelliSep to provide test results in under 10 minutes. The emergency department-focused tool helps clinicians recognize sepsis and make time-sensitive critical decisions. It provides actionable answers directly from a standard blood draw.

The diagnostic categorizes patients into three bands according to their probability of sepsis. Band 1 indicates a low probability of sepsis and the probability increases through Band 3. These results can help optimize clinical outcomes and improve hospital resource utilization, Cytovale said.

Cytovale completed its CV-SQuISH-ED study of the diagnostic in early 2022 and plans for publication soon. Data from previous studies demonstrate the test’s potential in de…

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