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The best-selling pharmaceuticals of 2023: Immunology and oncology return to prominence

Note: This feature on the best-selling pharmaceuticals of 2023 will be updated regularly as new data becomes available. Stay tuned for our ongoing coverage of the pharma sector’s sales dynamics.

[Scanrail/Adobe Stock]

In 2023, as the grip of the COVID-19 pandemic began to loosen, the pharma sector returned to relying on immunology and oncology as sales drivers. So far this year, the two segments are on track to be the strongest in the pharma landscape. In the first half of 2023, the immunology and oncology domains drove sales of $31.110 billion and $37.982 billion, respectively, based on a review of financial data from 13 Big Pharma companies. Conversely, the infectious disease segment accumulated sales of approximately $28.587 billion.

Contrasting the boom of prior years, 2023 has seen a pronounced dip in the appetite for SARS-CoV-2 vaccines. For instance, the Pfizer-BioNTech vaccine generated roug…

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Synchron’s plan to beat Neuralink in the neuroprosthetic BCI race

Synchron Chief Commercial Officer Kurt Haggstrom [Photo courtesy of Synchron]

Competing brain-computer interface (BCI) developers Synchron and Neuralink both announced big news this month as they move their dueling neuroimplant technologies forward.

The device developers each have FDA investigational device exemption (IDE) for their experimental BCIs. They’ve also got billionaires backing their R&D and regulatory efforts, with Neuralink owned by Elon Musk and Synchron funded by Jeff Bezos and Bill Gates.

This month, Synchron announced the completion of patient enrollment in its COMMAND clinical trial. Two weeks later, Neuralink announced the start of recruiting for its own clinical trial, the PRIME first-in-human study.

With BCI technology advancing as one of the hottest spaces in medtech innovation, Synchron Chief Commercial Officer Kurt Haggstrom discussed the competitive landscape and…

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Dexcom, RxFood partner on AI-based nutrition, glucose monitoring for diabetes management

Within the RxFood app, Dexcom CGM users can capture photos of their meals. It eliminates the need for manual food and nutrition tracking. [Image courtesy of RxFood/Dexcom]Dexcom (Nasdaq:DXCM) announced that it teamed up with RxFood on a digital diabetes solution for people in Canada.

The first-of-its-kind partnership combines Dexcom’s continuous glucose monitoring (CGM) with RxFood’s AI-driven personalized nutrition assessments. The companies aim to introduce an improved digital health solution for people living with diabetes. It integrates food data with insulin dosing, exercise and glucose information.

RxFood made its next-generation app, featuring Dexcom CGM data integration, now available to healthcare program stakeholders in Canada. That includes clinics, hospitals, health authorities, pharmacies, insurers and employers. Through these programs, Canadians using the Dexcom G6 or G7 (once available) can access combined food and glucose data. It offer…

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USMI to debut Canady surgical robot

The Canady robotic AI surgical system. [Image courtesy of USMI]US Medical Innovations (USMI) today announced plans to display its Canady robotic AI surgical system at the start of next year.

USMI announced the planned debut in collaboration with the Jerome Canady Research Institute for Advanced and Biological Technological Sciences (JCRI-ABTS). They called the announcement “a ground-breaking achievement in surgical and robotic technology.” They plan to unveil the system at the First Global Surgical Oncology Summit in Jerusalem, Israel. It takes place between Jan. 30, 2024, and Feb. 2, 2024.

Canady delivers cold atmospheric plasma (CAP), a three-dimensional, non-contact biometric pulsed electromagnetic field. CAP selectively targets and kills microscopic tumor cells during surgery without damaging non-cancerous surrounding tissue.

The system features a motorized positioning arm, a speech recognition electrosurgical generator called ORLI and a con…

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Insightec scores positive coverage for ultrasound-based essential tremor treatment

The Exablate Neuro system. [Image from Insightec’s website]Insightec announced today that Humana became the fifth national payor in the U.S. to cover its ultrasound treatment for essential tremor.

The Haiefa, Israel, and Miami, Florida-based company develops the Exablate Neuro system. It uses focused sound waves safely guided by MRI. The system provides tremor treatment to patients with medication-refractory essential tremor and Parkinson’s disease. Focused ultrasound has FDA approval to treat both sides of the body. The second treatment occurs at least nine months after the first side for eligible patients.

Humana’s coverage extends to ultrasound treatment for medication-refractory essential tremor.

“We are pleased that this positive decision will expand access to focused ultrasound for more commercial patients,” said Dee Kolanek, Insightec VP of market access and reimbursement. “We are grateful to top insurers like Humana for…

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Akili launches its over-the-counter digital ADHD treatment for Android devices

A child uses the EndeavorRx digital therapeutic. [Image courtesy of Akili]Akili (Nasdaq:AKLI) today announced the over-the-counter (OTC) availability of its EndeavorOTC digital ADHD treatment.

Boston-based Akili last week announced a shift toward a non-prescription business model with its OTC offerings. In doing so, the company enacted a workforce reduction of approximately 40%. It included the elimination of the company’s field sales force and market access team.

That move followed a January workforce reduction of 30%, which totaled 46 workers. The company is one of many to slash headcounts as layoffs took medtech by storm recently.

Akili’s launch for EndeavorOTC comes on the Google Play market for popular Android devices. According to a news release, of the estimated 11 million adults with ADHD in the U.S., approximately 40% use Androids. The company believes this marks a crucial step in offering an accessible non-drug treatment option to adults wit…

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Abbott completes Bigfoot Biomedical acquisition

The Bigfoot Unity platform, now acquired by Abbott. [Image courtesy of Bigfoot Biomedical]Abbott (NYSE:ABT) announced today that it completed its previously announced acquisition of Bigfoot Biomedical.

Pursuant to the terms of the merger agreement, upon completion, Bigfoot became a wholly-owned subsidiary of Abbott. The companies declined to disclose financial terms.

Abbott announced on Sept. 5 that it entered into a definitive agreement to acquire the smart insulin management company. Their longstanding relationship dates back to 2017, with the medtech giant even leading a financing round for Bigfoot in 2020.

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

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Fast Five: Hologic, Bayer partnering for mammography imaging, Medtronic wins CE mark for next-gen CGM

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, September 22, 2023.

Fast Five by MassDevice · Hologic, Bayer partnering for mammography imaging, Medtronic wins CE mark for next-gen CGM

There are more funding raises in the news this week. The first one is from MedTrace, which raised $19 million for its PET-boosting technology. Fast Five hosts Sean Whooley and Danielle Kirsh go over what the funding will go toward and the technology they’re developing. Read more here>>

ProSomnus is raising $10 million for its CPAP alternative. Find out what the technology is and how optimistic executives are about the future of the technology. Read more here>>

Whooley details a regulatory nod for Quantum Surgical’s surgical robot in China. Hear about what the robot does, what kind of treatment it offers and …

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Early data suggest adjunctive cariprazine could be a promising tool for tackling stubborn anhedonia in MDD

[Cariprazine image courtesy of PubChem]

The dopamine D3 receptor-targeting cariprazine could potentially be a new tool for managing anhedonia, one of the most stubborn symptoms of major depressive disorder (MDD). Characterized by a lack of enjoyment in previously pleasurable activities, anhedonia has been “difficult to address with traditional antidepressants,” said Dr. Vladimir Maletic, coauthor of a poster presented at the U.S. Psych Congress annual meeting held earlier this month in Nashville.

In a post hoc analysis focusing on the adjunctive use of AbbVie’s dopamine D-preferring D3/D2 cariprazine in MDD patients with an inadequate response to one to three antidepressant therapies, patients saw a notable improvement in overall depressive symptoms and, specifically, anhedonia symptoms. This improvement, measured with the Montgomery-Åsberg Depression Rating Scale (MADRS), was observable as early as week 2…

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How LimFlow’s foot-saving system prevents amputations in patients with no other options

LimFlow’s crossing stent diverts blood from a diseased tibial artery to a tibial vein to deliver oxygen to a patient’s ischemic foot. [Illustration courtesy of LimFlow]

LimFlow’s breakthrough system for treating chronic limb-threatening ischemia (CLTI) is the first of its kind approved by the FDA for this severe form of peripheral artery disease (PAD).

The LimFlow System for Transcatheter Arterialization of Deep Veins (TADV) is now the only option other than amputation for ceratin CLTI patients who have lost blood flow below their knee. LimFlow’s TADV system won breakthrough device designation in October 2017 and secured FDA premarket approval (PMA) in September 2023.

“A lot of technologies come out of people fiddling with technologies that already exist, and then developing unique proprietary solutions after that,” LimFlow CEO Dan Rose said in an interview with Medica…

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Relievant Medsystems unveils Intracept simulation training program

The Intracept procedure. [Image from Relievant Medsystems]Relievant Medsystems announced today that it released its Intracept simulator system, a training platform for the Intracept procedure.

Further progress for Relievant and Intracept follows Tuesday’s major news of an agreement for Boston Scientific to acquire the company. Boston Scientific officials went into further detail on their expectations for the Relievant deal at the company’s Investor Day yesterday.

Minneapolis-based Relievant develops the Intracept intraosseous nerve ablation system for chronic pain. The minimally invasive, FDA-cleared, same-day, outpatient procedure treats chronic vertebrogenic low back pain. Intracept utilizes targeted radiofrequency energy to ablate the basivertebral nerve (BVN). This stops the nerve from transmitting pain signals to the brain. The procedure takes approximately one hour to perform.

Relievant based its simulator system for Intracept on Medabilit…

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Hologic, Bayer partner on improved mammography imaging

Hologic (Nasdaq: HOLX) + and Bayer today announced an international partnership focused on improving breast cancer detection.

The companies teamed up to deliver contrast-enhanced mammography (CEM) solutions across Europe, Canada and Asia Pacific. CEM, a highly sensitive, relatively low-cost breast imaging modality combines digital mammography with contrast agent administration. It supports breast cancer diagnosis and guides treatment decisions.

Marlborough, Massachusetts-based Hologic said the partnership brings together its mammography gantries with Bayer’s CEM-approved injection systems. It enables the administration of contrast media during a mammography examination, according to a news release. The agreement allows the companies to support radiologists with a comprehensive product package and hands-on training.

“Over the past several years, we’ve seen an increased interest in contrast-enhanced mammogra…

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LivaNova president of cardiopulmonary is retiring

LivaNova (Nasdaq: LIVN) +  announced today that Marco Dolci intends to retire from his position as president of the cardiopulmonary business unit.

Dolci plans to retire by Dec. 31, 2023, continuing in his role to support the transition of responsibilities through the end of the year. The company appointed Franco Poletti to serve as interim GM of cardiopulmonary to support the transition. He’ll do so in addition to his current role as VP of cardiopulmonary for Europe, effective immediately.

The London-based medtech company plans to retain a leading international executive search firm to help find a permanent successor. It’s another high-profile executive departure for the company, which saw CEO Damien McDonald resign in April.

LivaNova noted Dolci’s role in the progress of its Essenz perfusion system, which just last month hit another regulatory milestone.

“On behalf of the board, the exec…

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MedTrace raises $19M for its PET-boosting technology

MedTrace Pharma seeks to bring 15 O-water production inside hospitals with its P3 automated point-of-care chemistry system. [Image courtesy of  MedTrace Pharma]MedTrace Pharma announced today that it has raised €18.2 million (roughly $19 million) to fund the completion of its Phase 3 trial of its tech to make PET with oxygen-15 labeled water widely available.

15 O-water has a reputation as a gold-standard radioactive tracer for PET imaging, but supply chain problems around the substance have hindered adoption. Hørsholm, Denmark–based MedTrace, which opened a U.S. headquarters in downtown Minneapolis last year, seeks to solve the problem by moving 15 O-water production inside hospitals with an automated point-of-care chemistry system. A Phase 3 clinical trial of the system kicked off last year. 

The investments surpassed MedTrace Pharma’s goal of raising €15 million — an achievement in a challenging fundraising environment that shows investors are confident i…

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Quantum Surgical earns regulatory nod for surgical robot in China

The Epione surgical robot system. [Image from Quantum Surgical]Quantum Surgical announced today that the National Medical Products Administration (NMPA) authorized its Epione surgical robot in China.

News of the regulatory nod comes just weeks after the last one for Quantum. It announced CE mark expansion for Epione to treat lung tumors earlier this month.

Montpellier, France-based Quantum’s flagship Epione robot enables the early and minimally invasive treatment of abdominal tumors. It allows surgeons to treat inoperable tumors that are particularly hard to reach due to size or location. The simple, effective platform provides treatment at an early stage.

A robotic-assisted percutaneous ablation system, Epione uses a robotic arm, a navigation system and a camera. It inserts a needle through the skin to the tumor and destroys it.

Epione can treat tumors in the liver, kidney and pancreas, in addition to the lung expansion it just received. It…

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ProSomnus raises $10M for CPAP alternative

The ProSomnus Therapy. [Image from the company’s website]ProSomnus (Nasdaq:OSA) announced today that it completed a $10 million convertible preferred equity offering.

The company earmarked the new capital to optimize its core business operations and support its strategic growth initiatives. It aims to achieve cash flow breakeven with these efforts. Spring Mountain Capital and Cetus Capital led the financing. The company’s Executive Chair, CEO and CFO also participated.

Pleasanton, California-based ProSomnus develops an alternative to CPAPs for treating obstructive sleep apnea (OSA). Its intraoral medical devices precisely track the treatment plan and anatomy of each patient. The FDA-cleared, non-invasive mouthguard-like devices have the backing of a “growing body of clinical investigations,” ProSomnus says.

It may be an opportune time for companies developing alternatives to to CPAP machines as Philips continues working to resolve it…

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Medtronic wins CE mark for next-gen Simplera CGM with InPen integration

The InPen and Simplera system. [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + announced today that it received CE mark approval for its new Simplera continuous glucose monitor (CGM).

The all-in-one, disposable CGM features a simple, two-step insertion process for people with diabetes using multiple daily injections (MDI). Medtronic’s newest no-fingerstick sensor eliminates the need for overtape, too. It seamlessly integrates with the InPen smart insulin pen for real-time, personalized dosing guidance to simplify diabetes management.

Medtronic plans to begin a phased launch for Simplera at the European Association for the Study of Diabetes (EASD) 59th Annual Meeting. It takes place in Hamburg, Germany, from Oct. 2-6.

Commercializing a new CGM comes at a good time for Medtronic, which could see the benefits from the newly popular GLP-1 drug class. Analysts recently outlined the ways in which those drugs m…

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Device strategies to prevent healthcare-associated infections

[Image courtesy of the National Institute of Allergy and Infectious Diseases]

Device design, sterilization before use and proper cleaning of reusable equipment can prevent infections and save lives.

By Ted Eveleth, AvantGuard

Nosocomial infections, also commonly known as healthcare-associated infections (HAIs), are a multibillion-dollar problem and a leading cause of morbidity and mortality around the world. On any given day, about 1 in 31 hospital patients has at least one HAI, according to the Centers for Disease Control and Prevention.

A significant cause for many of these HAIs are medical devices that touch or are implanted in the body, such as surgical implants, catheters and endoscopy devices.

For example, 75% of urinary tract infections in healthcare settings are associated with urinary catheters. Central line-associated bloodstream infection (CLABSI), another category of HAIs associate…

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Fast Five: Boston Scientific targets M&A to reach ‘next level’, EU sees potential antitrust activity in medtech

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, September 21, 2023.

Fast Five by MassDevice · Boston Scientific targets M&A to reach ‘next level’, EU sees potential antitrust activity in medtech

Today’s news covers Orthofix’s launch of its new fixation system and the first cases with the device were performed. Fast Five hosts Sean Whooley and Danielle Kirsh discuss what the system offers to patients and surgeons. Read more here>>

There is also more brain-computer interface (BCI) news this week from Neuralink, which has opened recruitment for its first-in-human BCI trial. Hear more about the study’s details and the path Neuralink took to get to this point. Read more here>>

Surgical robots are dominating the news this week. This time, CMR Surgical brought in $165 million in a fundi…

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High-profile drugs under the legal spotlight in 2023

[Adobe Stock]

In the wake of the COVID-19 pandemic, the U.S. has witnessed a surge in litigation. One factor driving the uptick in the pharmaceutical sector is the rise of copycat litigation. As mass tort activity amplifies, plaintiff lawyers are treating previously filed lawsuits as templates for new claims. Examples of the trend include steadily increasing nitrosamines litigation and allegations of laminal duct obstruction against the chemotherapeutic agent Taxotere (docetaxel), as Greenberg Traurig has noted. Additionally, plaintiff-affiliated labs are intensifying their efforts to test various products for potentially harmful chemicals.

Amidst this backdrop, the heartburn medication Zantac (ranitidine) has found itself at the center of a litigation storm. Data from X-Ante, a litigation analysis firm, reveals the drug is the most frequent drug target of mass tort TV advertising in 2023 based on estimated ad s…

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