New diagnostics, trials address deadly disparities in women’s cardiac care
While women with “big hearts” play well in popular culture, cardiologists see a very different picture – with significant implications for women’s health and medical care. Women have smaller hearts and narrower blood vessels than men and their cardiovascular systems respond to disease and treatment in very different ways. Growing evidence that failure to reflect women’s distinct anatomy in cardiac care leads to deadly disparities in outcomes has recently stimulated development of new diagnostics and increased focus on inclusion of women in medical device trials.

Devyser to democratize NGS test, seek US FDA approval
The recent agreement between Devyser Diagnostics AB and Thermo Fisher Scientific Inc. to collaborate to obtain U.S. FDA approval for a next-generation sequencing (NGS) test for kidney transplant monitoring allows the test to be democratized, Fredrik Alpsten, CEO of Devyser to BioWorld.

New diagnostics, trials address deadly disparities in women’s cardiac care
While women with “big hearts” play well in popular culture, cardiologists see a very different picture – with significant implications for women’s health and medical care. Women have smaller hearts and narrower blood vessels than men and their cardiovascular systems respond to disease and treatment in very different ways. Growing evidence that failure to reflect women’s distinct anatomy in cardiac care leads to deadly disparities in outcomes has recently stimulated development of new diagnostics and increased focus on inclusion of women in medical device trials.
Devyser to democratize NGS test, seek US FDA approval
The recent agreement between Devyser Diagnostics AB and Thermo Fisher Scientific Inc. to collaborate to obtain U.S. FDA approval for a next-generation sequencing (NGS) test for kidney transplant monitoring allows the test to be democratized, Fredrik Alpsten, CEO of Devyser to BioWorld.
Radiopharma Telix acquires FAP-targeting agents for bladder cancer
Radiopharmaceutical company Telix Pharmaceuticals Ltd. has inked a deal worth up to AU$264 million (US$171 million) to license and develop next-generation radiopharma imaging and therapy technology targeting fibroblast activation proteins found in a wide range of cancers.
Data, med tech and science to transform the NHS
The U.K. Secretary of State for Health and Social Care, Wes Streeting, says that he wants people to see the national health service as a neighborhood health service as he works towards reimagining the health system and bringing care into people's homes. Data, he said, will be at the heart of the transformation. So too will be the deployment of science and medical technologies.
‘Evo’ AI can design complete genomes
The development of new machine learning tools like Alphafold and Rfdiffusion has allowed scientists to predict the structure of proteins and design them for drug discovery purposes, among other uses. Now, scientists at the Arc Institute have created Evo, an AI model that generates DNA sequences and estimates their interaction with other molecules at single-nucleotide resolution, scalable to an entire genome.
Today's news in brief
BioWorld MedTech briefs for November 20, 2024.

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Digital health

Nevro wins CE mark for spinal cord stimulation technology
Regulatory
Nevro Corp. received CE mark certification for its HFX iQ spinal cord stimulation system that delivers pain relief.
Researchers pen novel QD-OLED tech for wearable electroceuticals
Clinical
South Korean researchers developed a novel quantum dot and parallel-stacked organic light-emitting diode (QD-PSOLED)-based wearable patch capable of being “freely tunable” in real-time, and described as a flexible and commercial-level technology with wide applications for health care wearables.
Inocras launches ‘panel-free’ whole genome MRD test for cancer
Cancer
For Inocras Inc., the benefits of whole genome sequencing are two-fold. First is its explicit usefulness in diagnosing and treating hard-to-treat diseases like cancer and rare diseases. The second, less apparent, benefit lies in the data generated in the process, and its applications to current and...
Helfie AI partners with Microsoft to democratize health care
Newco news
Mobile health platform company Helfie AI has partnered with Microsoft to offer Microsoft enterprise customers the ability to license Helfie’s cutting-edge health assessment tools directly through the Microsoft Azure Marketplace.

Financings

Investors and corporates bullish about 2025, Jefferies says
Deals and M&A
Investors and corporates in health care are optimistic going into 2025 as they believe that capital constraints in the sector are finally easing, according to a report by global investment bank Jefferies. The return of the IPO market and increased M&A activity contributed to an uptick in confidence...

Newco news

Identifyher patents wearable perimenopause tracking sensor
Women's health
The first filing to emerge from Identifyher Ltd. seeks to gain protection for a wearable sensor that women can wear daily to track potential symptoms of perimenopause, providing them with data that can be used to find the right management plan for their needs.

Fibra patents smart underwear for monitoring fertility
Artificial intelligence
The first patenting from Fibra Inc. sees its founder and CEO Parnian Majid describe their development of a non-invasive wearable device which tracks fertility data through the measurement of various physiological parameters.
IR spectroscopy, machine learning combine for cancer diagnosis
Cancer
The third PCT family of patenting to emerge from IR Medtek LLC, and its first as the sole named assignee, sees its CEO, Douglas Cohen, continue to build protection for the company’s platform which uses a light detection technology and machine learning to improve the accuracy of cancer diagnosis.

Deals and M&A

Med-tech deal and M&A volume up from last year
Analysis and data insight
Med-tech deal values hit their lowest point of 2024 in October, reaching just $15.9 million – a sharp drop from the $356.79 million recorded in September.
Half the population’s health needs are underserved
Conferences
While the size of the market is enormous, drug development and treatments for women’s health care still lag behind what is offered for men. There has been a renaissance in the past few years, however, led by investors and companies that have wrestled with determining exactly what encompasses...
Boston Sci to acquire Cortex, expand AF portfolio
Cardiovascular
Boston Scientific Corp. signed a definitive agreement to acquire Cortex Inc., from Ajax Health Inc. to develop an integrated mapping and ablation solution for cardiac arrhythmias. Cortex’s Optimap system employs a basket catheter and algorithm to identify active sources for atrial fibrillation...
Onward licenses BCI chip, Morgan Stanley sees $400B opportunity
Neurology/psychiatric
In an effort to shore up its position in a rapidly developing market for brain-computer interface (BCI) technologies, Onward Medical NV signed an exclusive license with France’s CEA-Clinatec to use its BCI chip as part the Arc-BCI system, which restores direct communication from the brain to the...
Hologic to acquire Gynesonics for $350M
Gynecology/obstetrics
Hologic Inc. signed an agreement to acquire Gynesonics Inc. for $350 million. The acquisition will significantly boost Hologic’s revenues from surgical gynecology and provide an option not met by the company’s current portfolio of products.

Europe

Medtronic receives CE mark for next generation Endoflip system
Gastrointestinal
Medtronic plc obtained a CE mark for its next generation Endoflip 300 system which measures pressure and dimensions in the esophagus and pylorus, in adults. The Endoflip can be used to help diagnose and treat thousands of people across Europe suffering with esophageal motility disorders.

Asia-Pacific

Holistic strategies needed to diagnose and treat endometriosis
Analysis and data insight
Endometriosis has been woefully under-recognized in the medical community, and consequently, the delay between onset and diagnosis is often quite long, with some women waiting up to 12 years for a diagnosis.

Gender bias leaves women at risk in cardiology treatment guidelines
Analysis and data insight
Gender bias in cardiac treatment guidelines is putting women at risk because guidelines are written based on clinical trials conducted mostly in men. As previously reported in BioWorld, nearly 70% of female patients are underdiagnosed for cardiovascular disease as women are grossly...
Duchembio files for IPO to grow radiopharma business
Financings
Radiopharmaceutical biotech and contract development and organization firm Duchembio Co. Ltd. filed a securities report to South Korea’s Financial Services Commission Nov. 11, kickstarting the IPO process to list on the Korea Exchange.

Clinical

FDA eases the way for cell and gene therapy companies
Conferences
Cell and gene therapy companies are the beneficiaries of positive changes along the regulatory path that the U.S. FDA is paving for them, according to a panel of executives who spoke at the BioFuture 2024 conference in New York.
BioFuture 2024: FDA eases the way for cell and gene therapy companies
Conferences
Cell and gene therapy companies are the beneficiaries of positive changes along the regulatory path that the U.S. FDA is paving for them, according to a panel of executives who spoke at the BioFuture 2024 conference in New York.
One-year data for TRISCEND II favorable for quality of life
Transcatheter Cardiovascular Therapeutics
The first year of data from the TRISCEND II study of the Evoque tricuspid valve by Edwards Lifesciences Corp. confirm the notion that reduced regurgitation has a big impact on patient well-being. While one-year data support the device’s safety,...
ACURATE study leaves Boston Scientific with lots of homework
Transcatheter Cardiovascular Therapeutics
The ACURATE study of the Accurate neo2 TAVR device by Boston Scientific Corp., failed to demonstrate the device is non-inferior to established devices, but the COVID-19 pandemic threw up some roadblocks.
Sirolimus gaining ground on paclitaxel for peripheral artery use
Drug design, drug delivery and technologies
The contest between the two main classes of antiproliferatives for circulatory system use continues as seen in a presentation at this year’s Transcatheter Cardiovascular Therapeutics.
ECLIPSE study suggests limited role for atherectomy in PCI cases
Transcatheter Cardiovascular Therapeutics
Atherectomy devices play a key role in dealing with calcified coronary arteries. But a study presented at this year’s Transcatheter Cardiovascular Therapeutics demonstrates that angioplasty balloons made a lot of headway in this clinical area,...

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