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FDA hands Lilly’s Alzheimer’s drug donanemab complete response letter

Last year, Lilly’s (NYSE:LLY) Alzheimer’s monoclonal antibody donanemab appeared to be a superior therapy to aducanumab from Biogen (Nasdaq:BIIB) and Eisai (OTCMKTS:ESALY), the first such antibody to win FDA approval. But facing criticism over its decision to grant accelerated approval to aducanumab, FDA has sent Lilly a complete response letter for the accelerated approval submission of donanemab to treat early symptomatic Alzheimer’s disease.

Specifically, the FDA noted that a limited number of patients with at least 12 months of drug exposure data were included in the submission.

LLY shares fell 2.23% to $343.26 in afternoon trading.

The Alzheimer’s Association supports the move

The Alzheimer’s Association released a statement praising FDA’s decision, saying that it appreciated its “methodical process in reviewing treatments for Alzheimer’s disease.”

The association noted that the FDA’…

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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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Activist investors pressure MindMed to accelerate clinical development, trim costs

[3D conformer image of LSD tartrate courtesy of PubChem]

The psychedelic therapeutics market could be worth billions of dollars in the coming years. The FDA has awarded breakthrough therapy designation to psilocybin and MDMA, potentially accelerating its approval of the currently Schedule I substances. 

Despite the promise, several psychedelic therapeutics companies have seen substantial drops in stock price. For instance, MindMed has seen its stock fall from nearly $65 per share in late April 2021 to $3.24 on January 18, 2023. 

Freeman Capital Management (FCM), which represents investors holding approximately 6.1% of MindMed’s total shares outstanding, believes the loss in stockholder value is essentially a result of the company’s lack of a clear strategic plan, poor communication to stockholders and a history of dilutive and damaging equity issuances. 

In August 2022, the firm sent a …

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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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Takeda and Boehringer Ingelheim selected as top pharma employers

The Top Employers Institute has named Takeda (TSE:4502/NYSE:TAK) and privately-held Boehringer Ingelheim to its list of 15 companies to win global Top Employer certification for 2023.

The Top Employers Institute rankings are based on data from its HR Best Practices Survey, which spans 20 topics, including people strategy, work environment, talent acquisition, learning, diversity and inclusion, well-being and other factors.

Takeda has been included in the ranking for six consecutive years. The company scored well in terms of ethics and integrity, purpose and values, business strategy, employer branding, organization and change.

On the employee review site Glassdoor, Takeda’s current ranking was 4.1 out of 5. A total of 82% of workers said they would recommend the company to friends, while 88% approved of CEO Christophe Weber.

[Related: 15 of the best pharma companies to work for]

In its ranking, Top Employers Institute praised Boehring…

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4 top drug discovery innovations of 2022

Prix Galien

Late last year, the Galien Foundation highlighted several drug discovery innovations in its annual Prix Galien USA Award Winners, which specifically highlighted drugs from Regeneron and Amgen as well as a platform from Exscientia and the incubators BioLabs and LabCentral.

The foundation recently hosted a webinar featuring several executives from the respective winning companies discussing their view on their respective drug discovery innovations.

1. Inmazeb: The first FDA-approved Ebola drug

The Galien Foundation chose Regeneron’s (Nasdaq:REGN) Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) as the best biotechnology product of 2022. The antibody cocktail became the first FDA-approved treatment for Ebola (Zaire Ebolavirus) for pediatric and adult patients in 2020.

There were several hurdles involved in developing Inmazeb, said Neil Stahl, EVP of R&D at Regeneron Phar…

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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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Philips, Masimo expand patient monitoring partnership with Masimo smart watch

[Image from Masimo]Philips (NYSE:PHG) and Masimo (Nasdaq:MASI) today announced that they expanded their patient monitoring partnership to home telehealth applications.

The companies extended their partnership to augment patient monitoring capabilities at home with the Masimo W1 watch. The advanced health-tracking watch first launched to early adopters in May 2022. It holds CE mark approval while FDA clearance is pending.

This system represents part of Masimo’s recently announced plan to turn home entertainment systems into health hubs.

Philips and Masimo plan to integrate W1 into Philips’ enterprise patient monitoring ecosystem to advance telemonitoring and telehealth. The companies expect to highlight their plans at Arab Health 2023 later this month.

Bilal Muhsin, Chief Operating Officer of Masimo Healthcare, said, “Expanding our partnership with Philips in this way is a win-win for patients and clinicians everywhere, and is an important…

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Bausch + Lomb buys AcuFocus and its intraocular lens tech

[Image from AcuFocus]Bausch + Lomb (NYSE:BLCO) announced that its affiliate acquired AcuFocus, a privately held maker of ophthalmic medical devices.

The deal remains pursuant to a merger transaction with the parent company of AcuFocus. Neither company disclosed the financial terms of the transaction.

AcuFocus develops small aperture intraocular technology. Its portfolio includes the IC-8 Apthera intraocular lens (IOL). The lens received FDA approval in July 2022. It’s the first and only small aperture non-toric extended depth of focus (EDOF) IOL for certain patients. These patients have as much as 1.5 diopters of corneal astigmatism. They also wish to address presbyopia at the same time.

The lens provides excellent distance vision through its small aperture technology, AcuFocus says. It also offers clear intermediate and near vision to mitigate the effects of presbyopia.

IC-8 Apthera’s commercial availability includes markets across Europ…

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Natus Medical closes acquisition of Micromed

Natus Medical today announced it completed the previously announced acquisition of Micromed Holdings.

The deal, announced in December 2022, will add Micromed’s neurophysiology solutions to Natus Medical’s offerings. The financial details of the acquisition were not disclosed.

The Micromed acquisition is the first transaction made by the Middleton, Wisconsin-based company since its $1.2 billion acquisition by the ArchiMed group in July 2022.

“We are thrilled to complete this deal and move forward combining the Natus and Micromed teams and product portfolios,” Natus President Austin Noll said in a news release. “Together, we will be able to provide our neuroscience customers a more comprehensive product offering and unrivaled global service and support through the increased breadth and depth of our combined resources.”

Natus Medical has specialized in 85 years of neurodiagnostic leadership. Micromed’s portfo…

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OstomyCure completes recruitment in trial for TIES implant

The TIES implant. [Image courtesy of OstomyCure]OstomyCure announced today that it completed patient recruitment in the pivotal clinical trial of its proprietary TIES implant technology.

Oslo, Norway-based OstomyCure developed TIES as an innovative titanium port. It designed it for implantation within a stoma, attaching lid to effectively open and close the stoma at the user’s convenience.

The company said it designed the device to end the reliance on a permanent ostomy bag for those with ileostomy.

OstomyCure said that 20 patients received TIES implants across participating hospitals in the UK, Sweden, Poland, Austria and India. The trial will monitor them for a further six months. It evaluates the safety and performance of the technology. OstomyCure plans to submit the analysis of its clinical data in its regulatory submissions for CE mark. It also intends to continue recruiting patients to build further evidence for the device.


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Moderna’s RSV vaccine mRNA-1345 was more than 80% effective in a Phase 3 study 

mRNA vaccine company Moderna (Nasdaq:MRNA) plans on submitting for regulatory approval for its investigational RSV mRNA-1345 vaccine after it met primary efficacy endpoints in the Phase 3 ConquerRSV study (NCT05127434).

The RSV data are “a clear positive for MRNA” and represent a good omen for upcoming mRNA Phase 3 influenza data, noted UBS in a briefing note.

MRNA shares were up 5.70% in after-hours trading, hitting $201.55.

“Importantly, we think this is a milestone for MRNA’s pipeline beyond COVID in demonstrating the competitive efficacy of mRNA vaccines,” noted UBS Eliana Merle. “We think RSV could be a meaningful opportunity with no vaccine yet approved.

UBS sees an opportunity worth more than $5 billion in RSV.

The Moderna study, enrolling roughly 37,000 adults aged 60 or older in 22 countries, tested mRNA-1345 in older adults divided into two groups. One group had two or more symptoms of RSV…

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