- Medical Design Sourcing

HelioLiver is a multi-analyte blood test that uses cell-free DNA (cfDNA) methylation patterns and serum protein markers to detect hepatocellular carcinoma (HCC), which is the most common form of liver cancer. The test is able to detect HCC at its earliest stages when lesions are still small to enable more curative treatment options.

Recent studies of the test showed that HelioLiver had “superior sensitivity” over currently available blood tests, according to a news release. It had a specificity of 91% and demonstrated 76% sensitivity in detecting early-stage HCC, outperforming other detection tools like AFP (57%), GALAD (65%) and ultrasound (47%).

“We are excited to offer patients at high risk of developing liver cancer a convenient and sensitive serial testing option to catch cancer early when it counts the most,” He…

HelioLiver launches liquid biopsy test for early liver cancer detection

Helio Health and commercial partner Fulgent Genetics this week announced the launch of the HelioLiver liver cancer blood test.

“We are excited to offer patients at high risk of developing liver cancer a convenient and sensitive serial testing option to catch cancer early when it counts the most,” He…

Integrated Computer Solutions, Variscite to collaborate on hardware and software solution

Integrated Computer Solutions (ICS) and Variscite announced today that they are collaborating on new solutions in the embedded market.

The collaboration aims to offer a complete hardware and software solution to customers in the market, with Variscite’s SoM (system on module) solutions and ICS’ best-in-class software services set to provide a complete system solution that offers customers accelerated development, decreased development cost and more reliable continuity of maintenance and support, according to a news release.

Waltham, Massachusetts-based ICS said Variscite is the only SoM vendor member in the NXP Platinum Parner program, assuring the highest quality and stable supply for its product portfolio, which includes VAR-SOM and DART.

ICS’ software solutions have already been implemented on Variscite’s modules in several projects to allow customers to have a significantly accelerated product release.

“We are ver…

FDA clears Amra Medical’s MRI-based muscle assessment scanner

Amra Medical today announced that its Amra Mass Scan has received FDA 510(k) clearance.

Sweden-based Amra Medical designed Mass Scan to provide magnetic resonance imaging (MRI) scans using muscle and fat biomarkers. It has a rapid neck-to-knee MRI protocol that produces actionable patient-specific reports.

Reports created by Mass Scan contain the muscle assessment score and precise body composition measurements with contextual insights based on the company’s reference database, as well as anatomic and color-coded segmented images.

“We are very excited to expand this technology to the US. The Amra Mass Scan will greatly benefit patients by allowing clinicians to objectively and accurately assess muscle quality and take action to ultimately improve patient outcomes,” CEO Eric Converse said in a news release. “The beauty of the report is that it is easy-to-understand, it creates a common language among clinicians with the muscle asse…

Movia Robotics launches TheraPal digital health aide for neurodiverse individuals

Movia Robotics this week announced that it has launched its TheraPal line of digital health aides for autism spectrum disorder and other intellectual or developmental disabilities.

Bristol, Connecticut-based Movia Robotics released its TheraPal Progress Tracker, TheraPal Home and TheraPal Clinical assist aides for use in homes and clinician offices. The robotic aides are designed to be used by parents, therapists and other healthcare professionals for the development and learning of individuals with neurodevelopmental or intellectual challenges, according to the company.

Get the full story on our sister site, Medical Design & Outsourcing.

Veranex acquires medtech design firm Worrell

Veranex today announced that it has acquired medtech design firm Worrell for an undisclosed amount.

Raleigh, N.C.-based Veranex delivers strategic, operations and financial benefits to medical device companies and engineers that are developing breakthrough technologies, according to the company. The acquisition of Worrell will expand its offerings and geographic reach.

“The addition of Worrell strengthens Veranex’s offerings as the leading global provider in the medical device and biotech space. By enhancing our human-centered design capabilities with a focus on Phase 0 strategy, design conceptualization, and human factors services, we complement our existing ISO-certified Phase 1-4 engineering and pilot-scale manufacturing capabilities,” Veranex executive chairperson Patrick Donnelly said in a news release. “We’re thrilled to welcome the employees of Worrell to Veranex.”

Worrell’s president Kai Worrell will join Veranex as president of its p…

GSK and Vir upbeat about efficacy of sotrovimab against Omicron

GlaxoSmithKline (LON:GSK) and its partner Vir Biotechnology (NSDQ:VIR) have announced that their COVID-19 drug sotrovimab continues to offer protection against the mutations in the spike protein of the Omicron SARS-CoV-2 variant.

In March, the two companies received emergency use authorization (EUA) for the drug. The EUA specifically covers the treatment of mild-to-moderate COVID-19 in high-risk adults and children.

Drawing on preclinical research, the two companies suggest that at least one dose of sotrovimab would protect against Omicron, which WHO has categorized as a variant of concern. The preclinical research involved pseudo-virus testing, including 37 mutations in the Omicron variant spike protein.

Formerly known as VIR-7831, sotrovimab is a monoclonal antibody.

The antibody is the first with “preclinical data demonstrating activity against all tested SARS-CoV-2 variants of concern and interest to date, including Omicron, as well as the sti…

Vapotherm announces executive leadership changes

Vapotherm this week announced that it has appointed Brian Lawrence as senior VP and chief technology officer and Dorota McKay as controller and chief accounting officer, effective immediately.

Prior to joining the company, Lawrence was chief technology officer and general manager of Gravity Diagnostics where he was responsible for technology and innovation programs across the company, according to an SEC filing. He has also held numerous leadership roles at Hillrom and GE Healthcare.

McKay most recently served as controller of Decibel Therapeutics. She has also held financial leadership roles at Oxford Immunotec Global, Altra Industrial Motion and Macpage.

LiveCare, AliveCor partner to launch at-home remote cardiac monitoring

[Image from AliveCor]LiveCare announced today that it successfully integrated AliveCor’s KardiaMobile 6L electrocardiogram (EKG) device into its platform.

New York-based LiveCare said in a news release that it integrated KardiaMobile 6L, a clinically-validated personal EKG device, within its LiveCare Link+ smart RPM gateway.

Through the integration, patients and caregivers will receive real-time EKG monitoring at home or in skilled nursing facilities, LiveCare said. Data aggregation of the AliveCor EKG data in concert with the LiveCare device and gateway propels LiveCare’s goal of delivering a fully automated RPM system for aiding geriatric patients across a range of chronic conditions, the company said.

“We are excited to partner with LiveCare,” AliveCor SVP of U.S. Healthcare Mark Bogart said in the release. “The integration of the KardiaMobile 6L EKG device with the Link+ Smart RPM Gateway will provide a more seamless real-t…

Movia Robotics launches TheraPal digital health aide for neurodiverse individuals

Movia Robotics this week announced that it has launched its TheraPal line of digital health aides for autism spectrum disorder and other intellectual or developmental disabilities.

Movia’s robot-assisted intervention is a friendly digital tool that uses applied behavior analysis and other evidence-based methods with gamification techniques to allow children and older individuals to practice a broad range of life skills and confidence-building activities.

The fully-configurable system has modules for cognitive training, communication training, practice and edu…

Philips recognized for its climate action leadership

Royal Philips (NYSE:PHG) announced today that it received recognition from environmental non-profit CDP for its climate action leadership.

Through its efforts in cutting emissions, mitigating climate risks and developing the low-carbon economy, Philips was included on CDP’s “A List” for the ninth consecutive year, according to a news release.

CDP’s scoring methodology assesses companies on the comprehensiveness of their disclosure, awareness and management of environmental risks and demonstration of best practices associated with environmental leadership, including setting ambitious and meaningful targets.

Philips said it is already carbon neutral in its operations with intentions to further reduce its CO2 emissions in line with 1.5°C global warming. Efforts include improving the energy efficiency of its products during the customer use phase and teaming up with customers and stakeholders to decarbonize healthcare.

Goals fo…

Cytena inks $10M deal to distribute its single-cell isolators in China

BICO subsidiary Cytena has reached a $10 million agreement with Applitech Pharmaceutical Equipment Technology to distribute its single-cell isolators in China with the intent to develop novel treatments such as gene therapies, biosimilars and monoclonal antibodies.

The two-year deal encompasses the use of almost 100 of Cytena’s single-cell isolators, including the UP.SIGHT devices. China represents the world’s second-largest life science market.

The UP.SIGHT automates steps involved in cell line development (CLD) workflows.

“The life science market in China is one of the most impressive in the world, and we’re thrilled with this deal to be able to help researchers there accelerate their life-saving work,” said Erik Gatenholm, CEO and co-founder of BICO, in a press release.

In October, Cytena debuted the C.Station automated cell line development platform for antibody and gene therapies.

D…

CereVasc successfully performs first-in-human procedure with eShunt system

CereVasc announced today that it completed the first treatment with its eShunt system for treating communicating hydrocephalus (CH).

Boston-based CereVasc touts the eShunt as the first minimally invasive cerebrospinal fluid shunt and delivery technology designed to avoid the need for invasive surgery and extended hospitalization associated with the current surgical treatment of hydrocephalus.

The company said in a news release that it designed the eShunt to offer improvements compared to the current treatment, a half-century-old neurosurgical procedure that is associated with frequent failure, infection risk and high costs.

Dr. Pedro Lylyk reported the first case as he conducts the first-in-human study of the eShunt system at Clinica la Sagrada Familia in Buenos Aires, Argentina. The ongoing trial will produce additional data in 2022, CereVasc said.

“Despite this being very early data, there is great significance in the first-ever treatment …

Inhaled drug delivery tech company Aerami to go public through SPAC merger

Aerami Therapeutics announced today that it entered into a merger agreement with FoxWayne Enterprises Acquisition Corp. (NSDQ:FOXWU).

Through the definitive business combination agreement with the special purpose acquisition company (SPAC), Aerami, a developer of inhaled therapies for treating respiratory and chronic diseases, will be listed on the Nasdaq market as “Aerami Therapeutics Holdings, Inc.”

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

Medtronic’s Hugo wins Health Canada license to expand robotic-assisted surgery

Medtronic’s Hugo robot-assisted surgery system [Image courtesy of Medtronic]Medtronic (NYSE:MDT) announced today that it received a Health Canada license for use of the Hugo robotic-assisted surgery system.

The company’s Brampton, Ontario-based Medtronic Canada subsidiary received the Health Canada license for use of Hugo in urologic and gynecologic laparoscopic surgical procedures.

According to a news release, those procedures make up about half of all robotic surgery procedures performed today.

“This license ushers in a new opportunity for healthcare in Canada, bringing the benefits of robotic-assisted surgery to more patients by addressing the historic cost and utilization barriers that have stifled robotic surgery adoption for two decades,” President of Medtronic’s Surgical Robotics Business Megan Rosengarten said in the release. “We’re beginning to see what the Hugo RAS system can do in the hands of clinicians in L…

The opportunities and challenges inherent in using protein biomarkers for new drug development

Image courtesy of Wikimedia Commons

Difficulties diagnosing disease earlier, failure to demonstrate efficacy, questions about safety and the sheer cost of testing constantly threaten new therapeutic development. But greater understanding and more widespread use of protein biomarkers have the potential to improve that narrative.

A biomarker indicates a medical state that can be measured accurately and reproducibly from outside a patient’s body. Think of measuring a patient’s blood pressure to diagnose hypertension and predict heart disease, heart attack or stroke. During drug development, a biomarker is evidence of disease at the molecular level, and a protein biomarker demonstrates that a human body reacted to a therapy. Monitoring the concentration of such proteins is a powerful tool to follow the outcome of a disease and a drug’s efficacy.

Protein biomarkers can bring clarity to invisible illnesses,…

Roche finalizes repurchase of shares from Novartis

Roche (SIX:RO,ROG) has announced that it has completed the repurchase of 53.3 million shares held by Novartis (NYSE:NVS) for a total consideration of $20.7 billion.

In early November, the companies had announced that they had agreed to a bilateral transaction related to the sale of the shares.

Roche intends on canceling the repurchased shares after the transaction is complete.

“With this transaction, we regain full strategic flexibility without compromising our operational scope of action,” said Christoph Franz, Roche chairman of the board of directors.

Roche had previously stated that the transaction would not affect its communicated outlook for 2021.

In related news, Novartis CEO Vas Narasimhan said the company plans on developing an oral therapy that would target an array of coronaviruses.

FDA authorizes COVID-19 antibody cocktail for younger children

The FDA will allow the use of Lilly’s (NYSE:LLY) bamlanivimab and etesevimab antibodies for younger pediatric patients, including newborns.

The revised expanded emergency use authorization (EUA) specifically includes children with mild-to-moderate COVID-19 who face a high risk of disease progression.

The EUA previously covered children at least 12 years of age who weigh at least 40 kilograms.

Get the full story from our sister site, Drug Discovery & Development.

FDA authorizes COVID-19 antibody cocktail for younger children

The FDA will allow the use of Lilly’s (NYSE:LLY) bamlanivimab and etesevimab antibodies for younger pediatric patients, including newborns.

The revised expanded emergency use authorization (EUA) specifically includes children with mild-to-moderate COVID-19 who face a high risk of disease progression.

The EUA previously covered children at least 12 years of age who weigh at least 40 kilograms.

The FDA will now allow the use of the antibody cocktail as post-exposure prophylaxis (PEP) to prevent COVID-19 in all pediatric patients with a high risk of progressing to severe COVID-19.

Bamlanivimab and etesevimab image courtesy of Lilly.

The expanded authorization is not intended to provide an alternative to vaccination, said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a press release. “Vaccines remain our best tool in the fight against the virus, an…

Instron launches Bluehill Central lab management software

[Image from Instron]

Instron announced today that it launched the Bluehill Central lab management solution for Bluehill Universal software.

Norwood, Massachusetts-based Instron’s Bluehill Central platform allows lab managers to remotely manage all test systems running Bluehill Universal, regardless of the number of systems and regardless of their location around the world, according to a news release.

The company said the new software uses a single database to manage Instron systems and data at the enterprise level in an effort to simplify the lab management process. It gives lab managers a method to manage tasks across all frames on their network, including all Bluehill Universal users and permissions, test method templates, results, file revision approvals and audit trail data.

Bluehill Central centers on groups of users sharing common files and settings, with an individual operator’…

9 predictions for pharma in 2022

Image courtesy of Pixabay

The pharma industry has been slower to embrace technologies such as AI and digital technology than many less-regulated sectors. The COVID-19 pandemic has changed the equation, forcing pharma companies to become more agile and open-minded in approaching drug discovery and development, including managing evolving clinical trials.

In this article, several experts offered their predictions of the trends that will be most meaningful in 2022.

1. Digital components drive new pharma value

Jaydev Thakkar

In 2022, a growing number of pharmaceutical companies will recognize how their products could deliver significantly improved outcomes with a digital component, predicted Jaydev Thakkar, chief operating officer of Biofourmis, which offers digital therapeutics and care-at-home solutions powered by AI. “This digital component c…

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