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Axonics receives Health Canada approval for rechargeable sacral neuromod

Axonics (Nasdaq:AXNX) announced today that Health Canada approved its fourth-generation rechargeable sacral neuromodulation (SNM) system.

Irvine, California-based Axonics’ R20 neurostimulator received labeling for a functional life in the body of at least 20 years. It reduces how frequently a patient must recharge their implanted device to once every six to 10 months. The devices charge for only one hour.

The previous generation of the device had a recharging interval of once a month for one hour. R20 utilizes the same small 5cc form factor as that device and pairs to the same tined lead and patient remote control.

“Since Axonics’ founding, delivering superior patient experiences has been at the forefront of our development efforts,” said Raymond W. Cohen, CEO of Axonics. “Patients with overactive bladder want efficacy and a long-lived solution to address their chronic condition. The Axonics R20 represents a significant breakthrough for rechargeabl…

Tandem Diabetes Care to acquire patch pump maker AMF Medical

The Sigi insulin patch pump. [Image courtesy of Tandem Diabetes Care/AMF Medical]Tandem Diabetes Care (Nasdaq:TNDM) announced today that it acquired AMF Medical, maker of the Sigi patch pump for insulin delivery.

Switzerland-based AMF Medical currently develops the Sigi patch pump and does not offer it commercially. The system received FDA breakthrough device designation just over one year ago.

AMF Medical designed Sigi as an ergonomic, rechargeable patch pump for reducing the burden of diabetes management. It uses pre-filled insulin cartridges and offers compatibility with automated insulin delivery technology.

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

Pharmaceutical industry trends: 2023 outlook

[Gene editing image courtesy: Illustration by Jill George using images from the National Human Genome Research Institute & the National Institute of Allergy and Infectious Diseases]

If your only tool is a hammer, everything looks like a nail. Such was the state of the pharmaceutical industry a decade ago. Gone are the days of pharmaceutical companies predominantly specializing in single modalities such as traditional vaccines, monoclonal antibodies, plasma-derived therapies or small molecules. Today’s Big Pharma, fueled by the acquisition of countless startup companies, are ensuring their toolboxes are flush with the trusty tools of the past decades. In addition, Big Pharma companies are leveraging the power of new tools in the form of advanced therapeutic modalities. Consequently, the pipelines of leading companies in the pharmaceutical industry are increasingly comprised of complex new modalities such as cell the…

GSK announces plans for new headquarters in London

GSK plc (LSE/NYSE:GSK) has announced its plans to move to its global headquarters to a new building in central London in 2024.

The company is currently based in Brentford, a suburban town in West London.

GSK isn’t the only Big Pharma company to announce a headquarters change. In late November, Sanofi (Nasdaq:SNY) moved its home base to Paris’s 17th arrondissement neighborhood.

The company terms its new six-storied headquarters as the ‘Earnshaw.’

Approximately 3,000 employees will be based at the site. It will have offices for the company’s C-suite. It will also have space for the company’s R&D team, and employees focused on the supply chain, operations, corporate functions and HIV-focused ViiV Healthcare, a joint venture with Pfizer and Shionogi.

The headquarters will be a hybrid working environment.

Construction of the Earnshaw building is slated for completion in 2023.

GSK spun out its consumer division, which it branded…

Researchers develop wearable monitor that measures ECG and SCG signals simultaneously

A researcher examines the health monitor part of the wearable device under a microscope in Yan’s lab. [Image courtesy of Pate McCuien/University of Missouri]

Researchers at the University of Missouri received a $2.6 million grant from the NIH to develop a multifunctional, wearable heart monitor.

Funding helps the researchers create a breathable material with antibacterial and antiviral properties. This supports their ongoing development of the heart monitor.

According to a post on the university’s website, they designed the device to continuously track human heart health. It does so by monitoring dual signals simultaneously. Its electrocardiogram (ECG) function measures the heart’s electrical signal while a seismocardiogram (SCG) measures vibrations. After the recording on an electronic device, users can share their information with their healthcare provider to identify potential warnin…

VitalConnect wins Frost & Sullivan innovation award for patient monitoring device

[Image from VitalConnect]Frost & Sullivan today recognized VitalConnect with its 2022 North America New Product innovation award for its biosensor technology.

VitalConnect’s biosensor monitors patients and detects multiple health problems.

According to a news release, the platform reduced hospital workloads by enabling home monitoring. Patients who prefer to move freely could use the comfortable, state-of-the-art cardiac monitoring device. It demonstrated the same effectiveness and quality as existing hospital- or home-based devices.

“With an embedded biosensor, the four-inch medical-grade wearable miniaturizes the observational capabilities of an ICU. The unique cardiac monitoring technology simultaneously examines eight essential patient vitals, looking for 21 different cardiac arrhythmias while sending all patient data to a secure cloud in real-time,” said Varun Babu, senior industry analyst at Frost & Sullivan. “Tradition…

Health Canada licenses Medtronic extended-wear infusion set for insulin delivery

[Image from Medtronic]Medtronic (NYSE:MDT) Canada announced that Health Canada licensed its Medtronic Extended infusion set for insulin pumps.

The Medtronic Extended Infusion Set represents the first and only infusion set labeled for a wear time of up to seven days. The infusion set for delivering insulin from a pump to the body typically requires changing every two to three days.

Its availability covers customers using MiniMed 600 and 700 series pumps. Medtronic developed it in partnership with Convatec Infusion Care.

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

How to show empathy through digital health apps

Empathetic app design encourages patients to stick to a treatment plan, empowers them to participate in their own care and improves their health.

This app for overactive bladder encourages patients for participating in their treatment. [Image courtesy of TXI]

Rex Chekal, TXI

Adoption of digital health tech has exploded during the pandemic, but the story is different for digital health apps.

Just 18 percent of patients used a digital health app in 2021, a major drop from previous years. One reason for lagging adoption? A lack of empathy in design.

Using a digital health app can be a highly personal experience, and patients want an app that makes them feel cared for.

With an empathy-first approach to app development, digital health leaders can boost app adoption, which helps patients adhere to treatment protocols and leads to better health outcomes.

Listen to your users

Many digital he…

Dexcom partners with Green Shield, Health Depot on digital diabetes management service

The Dexcom G6. [Image courtesy of Dexcom]Dexcom (Nasdaq:DXCM) announced today that it partnered with Green Shield and The Health Depot to expand access to the Dexcom G6.

The partnership offers Green Shield plan members convenient access to the G6 real-time continuous glucose monitor (rtCGM). It combines this access with virtual diabetes coaching support.

Green Shield plan members eligible for G6 coverage can register for the new Digital Diabetes Care program. It offers them exclusive access to convenient and coordinated diabetes management support services in Canada.

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

FDA clears RF Medical radiofrequency ablation system

[Image courtesy of RF Medical]RF Medical announced today that the FDA cleared its Mygen M-3004 generator and specialized electrodes, including Myoblate.

The Korea-based thermal ablation system manufacturer made both products commercially available in the U.S.

According to a news release, the technologies help to modernize the standard of care for minimally invasive practices.

“The world’s medical device market is showing remarkable growth driven by cutting-edge minimally invasive technology and its industrial value is limitless,” said RF Medical CEO Mike Jun. “RF Medical is working diligently in an effort to keep pace with the advanced medical market. Improving the health and safety of mankind is our top priority and we are dedicated to carrying our mission as a leading medical device company through continuous investments in superior workforce and R&D.”

Mygen M-3004 enables a combination of monopolar and bipolar mod…

Boston Scientific to acquire majority stake in interventional tech developer Acotec

Boston Scientific (NYSE:BSX) announced that it intends to make a partial offer to acquire a majority stake in Acotec.

Marlborough, Massachusetts-based Boston Scientific’s offer could add up to a maximum of 65% of Acotec’s shares. Its proposed price totals HK$20 per share. That amounts to approximately $523 million for the 65% stake at current exchange rates.

Acotec, a Chinese medical technology company offers solutions for a range of interventional procedures. Its offerings include drug-coated balloons (DCBs) for treating vascular and other diseases. The company launched the first peripheral DCB in China in 2016. It also offers radiofrequency ablation technologies and thrombus aspiration catheters, along with more than 20 other products in various development stages.

According to a news release, Acotec generated approximately $53 million in sales for the 12-month period ended June 30, 2022.

“Acotec is a profitable, fast-growing c…

Smiths Medical issues urgent device correction for some CADD infusion pumps

Smiths Medical today issued an urgent medical device correction letter to inform customers of potential issues with its CADD infusion system.

The company — which ICU Medical acquired in January for $2.35 billion — identified two potential issues with the infusion sets. They relate to the potential lack of delivery or underdelivery and false no disposable attached (NDA) alarms.

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