News and Resources from the WTWH Media Life Science Network - Page 6 of 977

ICU Medical’s Smiths Medical is reportedly closing a New Hampshire plant, cutting 220 jobs

ICU Medical’s Smiths Medical unit reportedly plans to close a New Hampshire manufacturing facility that houses about 220 employees.

The infusion technology maker plans to close the plant in Keene, New Hampshire, next year, according to the Keene Sentinel. The outlet said VP of Global Marketing, Tom McCall, confirmed the decision to close today after employees received word yesterday.

McCall reportedly told the Sentinel that the decision came as a result of a manufacturing capability redundancy following ICU Medical’s $2.35 billion acquisition of the company in 2022. The VP said the company decided that it needed to consolidate its manufacturing footprint and transfer the manufacturing from Keene to other locations.

According to the report, all employees receive 60 days notice before they are let go from their position. Smiths Medical plans to provide those employees with severance pay and benefits to aid in the transition.

Smiths Medical’s …

Conmed appoints new chief operating officer

Conmed (NYSE: CNMD) + announced that it promoted Patrick Beyer to the newly created role of COO.

Beyer previously served as president of international and global orthopedics at the Largo, Florida-based company. In his new role, his responsibilities include leading commercial businesses, plus operations, distribution, regulatory/quality and customer excellence.

“Pat has been invaluable in driving Conmed’s above-market growth and expanding our presence in key markets,” said Curt R. Hartman, Conmed chair, president, and CEO. “He is an experienced leader with a proven track record of commercial and operational excellence and delivering results, and I look forward to Pat’s continued impact on the organization.”

Beyer joined Conmed in 2014 as president of international. In October 2020, he received a promotion to the role of president of international and global orthopedics. He served in that post for nearly fou…

Study highlights benefits of automated insulin delivery for children in UK

The MiniMed 780G with Guardian 4 and a 7-day infusion set. [Image courtesy of Medtronic]A study in the UK demonstrated significant improvements in HbA1c for users of automated insulin delivery technologies.

This comes on the heels of a UK NHS initiative to provide tens of thousands of children and adults with type 1 diabetes in the country with an artificial pancreas.

The study aimed to assess the efficacy of hybrid closed-loop systems at 12 months. It looked at HbA1c, time in range, hypoglycemia frequency and quality of life measures among children and young people with type 1 diabetes.

Investigators conducted the study between Aug. 1, 2021, and Dec. 10, 2022 across eight pediatric diabetes centers in England. They utilized three automated insulin delivery systems, all fully funded by the NHS:

Tandem t:slim X2 pump with Control IQ technology in combination with the Dexcom G6 CGM. Medtronic MiniMed 780G with Guardian 4. Ypsomed YpsoPump with CamDiab Ca…

Public vs. private: Who’s leading the charge in H5N1 preparedness?

[James Thew/Adobe Stock]

The recent emergence of H5N1 avian influenza in humans and many other animals has intensified global efforts to prepare for a potential pandemic. Public health agencies and international organizations are collaborating with pharmaceutical companies and academic institutions to develop vaccines, treatments, and strategies to mitigate the impact of an outbreak. The CDC, for instance, has released interim guidelines for dealing with the highly pathogenic virus, including recommendations for antiviral treatment.

While government agencies and international organizations are leading the charge on public health guidance, surveillance and research initiatives, private pharma firms are driving the development and manufacturing of H5N1 vaccines and antivirals, often in sync with academic institutions and with support from public funds.

Global efforts ramp up H5N1 pandemic preparedness

While…

Tips on Bluetooth, batteries and Apple vs. Android from Eko Health co-founder and CEO Connor Landgraf

Eko Health’s Core 5000 digital stethoscope has a rechargeable lithium-ion battery that lasts up to 300 minutes of continuous use, or up to 60 hours of regular clinical use. The stethoscope uses Bluetooth 4.2 low-energyand offers a wireless listening option. [Photo courtesy of Eko Health]

Eko Health has learned a bit about batteries and Bluetooth while developing AI-powered medical devices to help physicians detect cardiovascular disease.

Eko Health’s devices include hardware — in the form of its Duo and Core digital stethoscopes — and algorithms that analyze the acoustic and electrocardiogram (ECG) signals collected by those handheld devices. Together, their hardware and software is cleared by the FDA to detect heart murmurs, atrial fibrillation (AFib) and signs of low left ventricular ejection fraction.

Related: How Eko Health’s AI-powered stethoscope detects early signs of heart failure

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AtaCor Medical closes $28M Series C extension

AtaCor Medical announced today that it completed a $28 million Series C financing round to support its cardiac pacing and defibrillator technology.

Arboretum Ventures led the financing round. Existing investors Longview Ventures, Hatteras Venture Partners, Catalyst Health Ventures and BayMed Venture Partners participated, too.

San Clemente, California-based AtaCor plans to use the funds to support an FDA submission for its extravascular (EV) temporary pacing lead system. It also intends to complete a pilot study for the third generation of its EV-ICD (implantable cardiac defibrillator) lead system.

AtaCor’s proprietary EV cardiac pacing and defibrillation lead systems provide critical cardiac rhythm management (CRM) therapy. They offer benefits without requiring the placement of any hardware inside the patient’s heart.

Temporary pacing lead placement eliminates the need for medical imaging, leading to faster, less invasive therapy deli…

FDA wants to advance health equity through home-based care

The FDA has announced an initiative to reimagine the home environment as an integral part of the healthcare system and promote health equity for all Americans.

The new initiative, called “Home as a Health Care Hub,” seeks to address the longstanding disparities in healthcare access and outcomes using home-based care. FDA’s Center for Devices and Radiological Health (CDRH) said the move comes amidst a shifting clinical care landscape brought on by the COVID-19 pandemic.

In a joint statement, FDA CDRH Director Jeff Shuren and Deputy Director for Transformation Michelle Tarver said the healthcare system faces persistent challenges. These include shortages of healthcare professionals, rising costs and disparities in access that can affect more marginalized communities.

Related: Biden signs executive order for women’s health research and innovation

When devices don’t operate together, the FDA says pat…

Blue Arbor wins FDA breakthrough nod for neuromuscular interface

A screenshot from a Blue Arbor video demonstrating the capabilities of the Restore system.

Blue Arbor Technologies announced today that it received FDA breakthrough device designation for its Restore neuromuscular interface system.

The FDA also accepted the system into its Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot. TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices.

Grass Lake, Michigan-based Blue Arbor designed Restore to integrate into the peripheral nervous system with available robotic prosthetics. It aims to restore naturalistic hand and arm function in patients with upper limb loss. The platform could enable patients to move upper limb prosthetic devices with improved dexterity, speed and reliability.

Features of the Blue Arbor Restore system

Restore features implantable intramuscular electrodes, a sensing uni…

Boston Scientific stock is up as Farapulse drives Q1 beat, raised guidance

Boston Scientific (NYSE: BSX) + shares got a boost this morning on first-quarter results that came in ahead of the consensus forecast.

Shares of Boston Scientific ticked up nearly 7% to $73.66 apiece in early-morning trading today. They got as high as $74.39 during the day, marking a 52-week best for the company. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose slightly.

The Marlborough, Massachusetts-based company reported profits of $495 million. That equals 33¢ per share on sales of $3.86 billion for the quarter ended March 31, 2024.

Boston Scientific recorded a 65% bottom-line gain on a sales increase of 13.8%.

Adjusted to exclude one-time items, earnings per share came in at 56¢. That landed 5¢ ahead of expectations on Wall Street. Sales also beat The Street as experts projected…

FDA approves pair of therapies for rare pediatric cancers: Novartis’ Lutathera and Day One’s Ojemda

[peterschreiber.media/Adobe Stock]

The FDA has signed off on two novel therapies targeting rare pediatric cancers. Novartis’ Lutathera targets aggressive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in children 12 and up, while Day One Biopharma’s Ojemda (tovorafenib) tackles treatment-resistant BRAF-mutated relapsed or refractory pediatric low-grade glioma (pLGG) with a BRAF fusion or rearrangement, or BRAF V600 mutation

These approvals offer new treatment possibilities for young patients with rare pediatric cancers who previously had limited treatment options. The FDA’s decisions highlight the growing focus on developing targeted therapies for these underserved malignancies.

Lutathera targets rare gastrointestinal cancers in children

Lutathera, a radioligand therapy (RLT) from Novartis, has won an indication for the treatment of pediatric patients 12 years and older with som…

FDA clears Sail Fusion’s BowTie Sacroiliac Fusion System

Sail Fusion today announced it received FDA 510(k) clearance for its BowTie Sacroiliac Fusion System.

The Del Mar, California-based sacroiliac device company designed the device to incorporate intra-articular and transfixing components. BowTie minimizes tissue disruption, thoroughly prepares the joint, and provides rigid fixation to enable robust arthrodesis.

“There hasn’t been meaningful differentiation in the SI fusion market for many years,” President and CEO David Jansen said in a news release. “By interviewing hundreds of surgeons, we were able to identify an unmet need for robust fixation built on proven AO principles. Our approach challenges the prevailing trend of lateral fixation that is more appropriate for stabilization rather than true joint fusion. To achieve this, BowTie leverages decades of clinically validated arthrodesis methods that have been applied to nearly every other joint.”

The MIS BowTie device has a bowtie shape and integrated t…

Medtronic names new chief regulatory officer

Medtronic Chief Regulatory Officer Yarmela Pavlovic [Photo courtesy of Medtronic]Medtronic (NYSE: MDT) + officials today shared that the medtech giant named Yarmela Pavlovic as its new chief regulatory officer.

Pavlovic posted the news on LinkedIn: “I’m excited to share that I’ve recently been named chief regulatory officer for Medtronic. Medtronic products touch the lives of 74 million patients per year, and I’m honored to continue to support our global mission.”

According to her LinkedIn profile, Pavlovic joined Medtronic as VP of regulatory strategy in July 2021. She held that role until April 2023, when she became VP of global regulatory affairs, strategy and policy. Pavlovic was a partner at law firms Manatt, Phelps & Phillips and Hogan Lovells after starting her career as an attorney at Pepper Hamilton in 2003.

As Medtronic’s chief regulatory officer, Pavlovic will lead regulatory affair…