Vicentra developing next-gen insulin delivery system, eyes US market
Vicentra BV aims to make its Kaleido 2 insulin patch pump and automated insulin delivery system even smaller than its current device, already amongst the smallest, lightest and most precise insulin device on the market, new CEO Tom Arnold told BioWorld. As the company works to meet growing demand for its product, Kaleido has the potential to transform diabetes care, he said.

Researchers develop visual prosthetic to restore sight
Researchers from the Albert Einstein College of Medicine filed for protection of the development of a lateral geniculate nucleus (LGN) visual prosthetic device with implantable electrode arrays that stimulate the LGN and restore vision.

Vicentra developing next-gen insulin delivery system, eyes US market
Vicentra BV aims to make its Kaleido 2 insulin patch pump and automated insulin delivery system even smaller than its current device, already amongst the smallest, lightest and most precise insulin device on the market, new CEO Tom Arnold told BioWorld. As the company works to meet growing demand for its product, Kaleido has the potential to transform diabetes care, he said.
Researchers develop visual prosthetic to restore sight
Researchers from the Albert Einstein College of Medicine filed for protection of the development of a lateral geniculate nucleus (LGN) visual prosthetic device with implantable electrode arrays that stimulate the LGN and restore vision.
AI legislation advances in US states as Washington dithers
Several American states are forging into a legislative vacuum where regulation of AI is concerned as Congress continues to delay action. Adoption of AI regulations on a state level increases the risk of a fragmented regulatory landscape, as already exists in U.S. privacy law, further complicating the path forward for med-tech companies deploying AI algorithms.
Have kit, will travel further: Telix PET-imaging agent approved by FDA
The U.S. FDA’s approval of Telix Pharmaceuticals Ltd.’s kit for preparing prostate-specific membrane antigen-PET imaging for prostate cancer widens the opportunities for patients who live far away from large hospitals. The FDA’s nod for the imaging agent, TLX007-CDx, now branded as Gozellix, has a long shelf life and needs less equipment and preparation compared to some other agents.
Fibrosight launches in US for AI-based, stain-free MASH imaging
Histoindex Pte Ltd. launched its laboratory-developed test for metabolic dysfunction-associated steatohepatitis (MASH), Fibrosight, in the U.S. as the company’s first in a suite of next-generation digital pathology solutions.
Today's news in brief
BioWorld MedTech briefs for March 20, 2025

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Digital health

Toilets could be the next big health device: Medical Korea 2025
Conferences
Seung-min Park, professor at Nanyang Technological University and cofounder of Kanaria Health, is working to manufacture smart bidets that can capture biomarker data from urine and stool automatically and enable continuous monitoring.
Legislation would authorize AI to write prescriptions
Regulatory
The unrelenting pressure on medical practice in the U.S. has sparked some innovations, but a legislative innovation is now in the works that would fundamentally shift how at least some drugs are prescribed. The Healthy Technology Act of 2025 (H.R. 238) would allow AI and machine learning algorithms...
Magicmirror on the wall, who’s the healthiest of them all?
Diagnostics
Nuralogix Corp.’s Anura Magicmirror seeks to answer questions more important than relative beauty with health insights gained via transdermal optical imaging technology and AI-powered insights into more than 100 health metrics. If Snow White’s stepmother had possessed one, she might have realized...
New AI fall prediction tool being rolled out across the NHS
Regulatory
The U.K.’s national health service (NHS) is rolling out a new artificial intelligence (AI)-powered tool which can predict a patient’s risk of falling with a 97% accuracy rate. The AI software designed by Cera Care Ltd. is already in use in more than two-thirds of NHS integrated care systems across...

Financings

Brainomix raises £14M for AI-powered imaging solution for stroke, lung fibrosis
Cardiovascular
Brainomix Ltd. raised £14 million ($18 million) in a series C financing round to expand its AI-powered imaging solution, Brainomix 360 Stroke, into the U.S. market. Funds will also go towards advancing the Brainomix 360 E-Lung, which can accurately predict the progression of lung fibrosis. “This...

Newco news

New Zealand’s Avasa develops world-first arterial coupler
Cardiovascular
New Zealand med-tech startup Avasa Ltd. has developed an arterial coupler that could save surgeons 30 minutes in the operating room to better connect arteries.

Astellas-Yaskawa JV to build robot-based cell production platform
Deals and M&A
Astellas Pharma Inc. is setting up a joint venture with Yaskawa Electric Corp. to develop a new cell production platform using Yaskawa’s dual-arm humanoid robot called Maholo.
EEG earpiece predicts seizures up to an hour before onset
Neurology/psychiatric
The first patenting from Theta Neurotech Inc. sees the company’s co-founders describe their development of a wearable earpiece that uses an electroencephalography technology and machine learning algorithms to alert epilepsy patients 30 to 60 minutes before they have a seizure.

Deals and M&A

Med-tech averages 150 deals monthly in 2025, plus $5B in M&As
Analysis and data insight
Med-tech M&A activity reached $10.35 billion in the first two months of 2025, with $4.81 billion in deals recorded in January and increasing to $5.55 billion in February. While total M&A value remained strong, the number of M&As dropped month-over-month, falling from 40 transactions in January to...
Vivani looking to get slim with Cortigent neurostimulation spin
Diabetes
The Vivani Medical Inc. combination appears to be over less than three years since its inception after the company reported plans to spin off Cortigent, the division that develops brain implants.
Repligen buying 908 Devices’ Bioprocess Analytics portfolio
Diagnostics
Repligen Corp. acquired 908 Devices Inc.’s desktop portfolio of four devices for bioprocessing process analytical technology (PAT) applications for $70 million in cash.
Ajax, Boston Sci partner to develop new heart failure treatment
Cardiovascular
Ajax Health LLC, with backing from the $4 billion KKR Health Care Strategic Growth Fund II, and Boston Scientific Corp. launched a new business, Flowmod, to advance a system for treating heart failure developed by Boston Sci.
Boston Scientific to acquire Sonivie for up to $600M
Merger
Boston Scientific Corp. agreed to acquire Sonivie Ltd., developer of a therapeutic intravascular ultrasound system for denervation to treat resistant hypertension, pulmonary hypertension and chronic obstructive pulmonary disease. On a 100% basis, the deal is valued at $600 million with $400 million...

Europe

UK government abolishes NHS England
In a move that surprised many across the health care sector, the U.K. government decided to scrap NHS England, the body which runs the national health service (NHS), and bring it under the control of ministers. “I don’t see why a decision about £200 billion of taxpayer money on something as...

Asia-Pacific

Australian patient first to leave hospital with Bivacor TAH
Cardiovascular
An Australian man in his 40s with severe heart failure was implanted with a Bivacor Inc. total artificial heart (TAH) and has been discharged from the hospital. He remained at home with the artificial heart for 100 days until he received a transplant earlier this week.

EU MDR backlog could create an opportunity for Australia
Regulatory
A slow-down in EU medical device audits due to the long-delayed transition to the EU Medical Device Regulation is leading to increased applications to Australia as small businesses bypass Europe altogether.
Red-hot market supports two med-tech IPOs in a day
Financings
With more than three weeks left in the first quarter, the value of med-tech IPOs for 2025 already exceeds the funds raised from all IPOs for med-tech companies in the last two years combined. Kestra Medical Technologies Ltd. provides a clear example of how fast the market is heating up, with a...

Clinical

Tandem’s Control-IQ+ looks like a smart move for insulin-using T2D
Diabetes
Tandem Diabetes Care Inc.’s Control-IQ+ automated insulin delivery system improved multiple measures of glycemic control in individuals with type 2 diabetes who use insulin, a study presented March 19 at the 18th International Conference on...
Sooma receives IDE for neurostimulation therapy for depression
Regulatory
Sooma Oy secured U.S. FDA investigational device exemption approval to initiate a pivotal study of its transcranial direct current stimulation medical device in people with major depressive disorder. The study will examine the efficacy of the...
Medtronic sees SMART TAVR results in small aortic annulus patients
Cardiovascular
Medtronic plc released positive results from a two-year trial of Evolut TAVR that demonstrated superior valve performance in patients with small aortic annuli.
Onward exploring spinal cord stimulation system to treat Parkinson’s
Neurology/psychiatric
Onward Medical NV’s spinal cord stimulation system Arc-IM is being investigated to explore its potential to help people with Parkinson's disease.
Scientists develop scanner to see undetectable breast tumors
Cancer
Scientists at the University of Aberdeen developed a new scanner that distinguishes breast tumor material from healthy tissue more accurately than current magnetic resonance imaging (MRI) methods.
Raft of FDA job cuts may slow med-tech approvals
Regulatory
In response to the news of reported layoffs at the U.S. FDA over the weekend, Advanced Medical Association president and CEO Scott Whitaker said in press release that these “significant job cuts could have a very negative impact on patient care in...

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