Sounds of relief as Masimo unloads audio division
News of the sale of Masimo Corp.’s consumer audio unit may be music to the ears of investors, even at the steep discount from its original purchase price. Samsung Electronics Co. Ltd.’s Harman International Industries Inc. unit snapped up the Sound United business for about $350 million – roughly one-third of the $1.025 billion Masimo paid for the company in 2022.

Precision Neuro leads BCI race following FDA clearance
The recent 510(k) clearance by the U.S. FDA for a core part of Precision Neuroscience Corp. brain-computer interface technology is certainly a boon for the company, and others developing the devices. For the millions of people suffering from health disorders, such as motor neuron disease, spinal cord injury or severe stroke, its sign that a solution which could transform their lives could be just a few years away.

Sounds of relief as Masimo unloads audio division
News of the sale of Masimo Corp.’s consumer audio unit may be music to the ears of investors, even at the steep discount from its original purchase price. Samsung Electronics Co. Ltd.’s Harman International Industries Inc. unit snapped up the Sound United business for about $350 million – roughly one-third of the $1.025 billion Masimo paid for the company in 2022.
Precision Neuro leads BCI race following FDA clearance
The recent 510(k) clearance by the U.S. FDA for a core part of Precision Neuroscience Corp. brain-computer interface technology is certainly a boon for the company, and others developing the devices. For the millions of people suffering from health disorders, such as motor neuron disease, spinal cord injury or severe stroke, its sign that a solution which could transform their lives could be just a few years away.
FDA posts regulation for 2018 test for hematological malignancies
The U.S. FDA in 2018 granted the de novo petition by Seattle-based Adaptive Biotechnologies Corp. for the company’s DNA test for evaluation of residual hematological malignancies, but waited until March 8, 2025, to post notice of the attendant regulation.
Oncosil’s brachytherapy device outperforms SBRT in pancreatic cancer
Oncosil Medical Ltd.’s brachytherapy device outperformed stereotactic body radiation therapy plus chemotherapy in patients with unresectable or borderline-resectable locally advanced pancreatic cancer, according to a comparative analysis.
M&A activity dominates Q1, nearly 99% total med-tech deal value
In the first quarter of 2025, the med-tech sector saw a total of $149.08 million raised through 475 deals. This marked a significant decline from the $519.14 million raised in Q4 2024, representing the smallest quarterly total recorded by BioWorld MedTech since 2018.
Today's news in brief
BioWorld MedTech briefs for May 8, 2025.

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Digital health

Med-tech financings and guidance strong despite tariffs
Deals and M&A
April data and first quarter earnings reports show remarkable resilience in med tech, even as other sectors continue to suffer in response to tariffs and changing regulations. Not that tariffs proved insignificant: several companies reported annualized impacts north of half a billion dollars, but...
Voinosis uses AI and voice analytics for early dementia diagnosis
Neurology/psychiatric
Seoul, South Korea-based Voinosis Co. Ltd. filed for potential worldwide protection of its AI-based system that allows for the early detection cognitive impairment, dementia, Alzheimer’s disease and hearing loss through voice analysis.
Advamed AI policy document criticizes FDA’s AI PCCP guidance
Regulatory
The Advanced Medical Technology Association released a policy proposal for AI in medical devices that took the U.S, FDA to task for its guidance for predetermined change control protocols for AI, stating that the guidance is “inconsistent with the statutory authority” for PCCPs.
Device makers wary of FDA guidance for AI-enabled software functions
Medical devices and technologies
The U.S. FDA’s January 2025 draft guidance for AI-enabled device software functions has not fared well in terms of industry response. Two major trade associations argue that the draft is at least somewhat redundant with existing agency guidance.

Financings

Safeheal secures €35M for endoluminal fecal bypass system
Gastrointestinal
Safeheal SAS raised €35 million (US$39.72 million) in an oversubscribed series C financing round for its temporary endoluminal fecal bypass system, Colovac, which is placed in the colon following colorectal resection. The funds will be used to complete an investigational device exemption pivotal...

Newco news

Wearoptimo’s hydration sensor outperforms gold standard tests
Clinical
Health care technology company Wearoptimo Ltd. developed a next-generation microwearable sensor that accurately detects hydration levels, outperforming the needle-based gold standard.

Patent filed for multiweek, multitarget CGM-like wearable sensor
Cardiovascular
Researchers from the University of Cincinnati filed for protection of an electrochemical aptamer-based biosensor technology with improved sensitivity and longevity, which has the potential for monitoring several biomarkers over sustained periods.
Updoc patents AI-powered diabetes management platform
Diabetes
The first patent from Palo Alto, Calif.-headquartered Updoc Inc. provides protection for their development of an artificially intelligent, voice-based method for prescribing, managing and administering at least one medication for management of type 2 diabetes to a patient.

Deals and M&A

Emerging markets presents opportunities for med tech
Financings
Med tech companies were reminded that there are opportunities in emerging and growing markets as they look for ways to adapt to the uncertainties created by the U.S. administration threats of import tariffs. With large populations, and relatively untapped markets, these opportunities represent...
Startup, strategic relationship dependent on fair terms
Europe
Partnership agreements between startups and strategics need to be based on terms that are fair otherwise they will be rejected.
DOJ rolls out task force for review of burdensome regulation
Regulatory
The U.S. Department of Justice recently announced the formation of a task force that will advocate the roll-back of regulations that affect a wide swath of sectors of the American economy. Health care is one of the areas of interest for the task force, which will examine state as well as federal...
Radnet doubles down on breast cancer with $103M Icad buy
Cancer
Radnet Inc. expanded its commitment to the use of AI in improving diagnosis of breast cancer with an all-stock purchase of Icad Inc. for approximately $103 million. The transaction is expected to close in the second or third quarter of 2025.
GE Healthcare taps into Japan radiopharma market with Nihon buy
Regulatory
GE Healthcare Technologies Inc. gained full ownership of Nihon Medi-Physics Co. Ltd. after acquiring the remaining 50% stake from Sumitomo Chemical Co. Ltd. on March 31.

Europe

Viromed signs deals for cold plasma technology devices
Dermatologic
Viromed Medical AG recently signed a couple of deals to get its devices based on cold plasma technology into the hands of clinicians to treat patients with skin diseases and pneumological infections.

Asia-Pacific

FDA issues CRL for Telix's glioma imaging agent, wants more data
Regulatory
The U.S. FDA issued a complete response letter (CRL) to Telix Pharmaceuticals Ltd. for its NDA for glioma imaging agent, TLX-101-CDx (floretyrosine F18 or 18F-FET, Pixclara), citing the need for additional confirmatory clinical evidence.

Med tech majors unfazed by tariffs
U.S.
First quarter earnings reports from Edwards Lifesciences Corp., Intuitive Surgical Inc. and Boston Scientific Corp. support trends seen earlier: Larger med-tech companies expect substantial tariff hits, but also have confidence that they can absorb the impact with fairly minor adjustments.
Sky Labs seeks global expansion of world’s first BP monitor ring
Clinical
Sky Labs Inc. CEO and founder Jack Byunghwan Lee reported on plans to greatly expand the market for the company’s blood pressure monitor ring, including seeking regulatory approvals for the CART BP products in the U.S., Europe and Japan.

Clinical

J&J reports completion of first cases with Ottava robotic system
Regulatory
Johnson & Johnson’s Medtech division reported the completion of the first cases in the clinical trial for the Ottava robotic surgical system. The cases mark the first clinical experience with the Ottava system, which has been a long time in...
Saliva test predicts prostate cancer better than PSA
Cancer
U.K. scientists developed a saliva-based test which better predicts the risk of prostate cancer than current prostate-specific antigen (PSA) blood tests by analyzing DNA to look for genetic variants linked to prostate cancer and calculating a...
PFA non-inferior, even superior, to cryoablation for paroxysmal AF
Cardiovascular
Pulsed field ablation using Boston Scientific Corp.’s Farapulse system was non-inferior and even superior, slightly, to Medtronic plc’s Artic Front Advance cardiac cryoablation system in treating patients with paroxysmal atrial fibrillation.
Radiopharmaceuticals stake more territory in breast cancer care
Cancer
Radiopharmaceuticals, including 16α-18F-fluoro-17β-estradiol (18F-FES) PET/CT, are emerging as powerful tools with new diagnostic and therapeutic potential in breast cancer diagnosis and treatment, Han Sang-won, professor from the department of...
AI used to ID abnormalities in unborn babies
Neonatal/pediatrics
The use of an AI tool could speed up the time it takes to do pregnancy scans by almost half and it is still able to identify any abnormalities in the fetus, researchers found. Results from a study showed the AI tool used to assist with 20-week...
Acrivon narrows focus for ACR-368 in endometrial cancer
Cancer
Acrivon Therapeutics Inc. provided updated phase II data for checkpoint kinase candidate ACR-368, highlighting promising response rates for biomarker-positive patients with endometrial cancer and raising the possibility of an accelerated pathway...

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